Digitala Vetenskapliga Arkivet

Change search
Refine search result
12345 1 - 50 of 217
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Rows per page
  • 5
  • 10
  • 20
  • 50
  • 100
  • 250
Sort
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
Select
The maximal number of hits you can export is 250. When you want to export more records please use the Create feeds function.
  • 1.
    Adams, Sally
    et al.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Penton-Voak, Ian S.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Harmer, Catherine J.
    Univ Oxford, Warneford Hosp, Dept Psychiat, Oxford OX3 7JX, England.
    Holmes, Emily A.
    MRC Cognit & Brain Sci Unit, Cambridge CB2 7EF, England.
    Munafo, Marcus R.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, article id 161Article in journal (Refereed)
    Abstract [en]

    Background: We have developed a new paradigm that targets the recognition of facial expression of emotions. Here we report the protocol of a randomised controlled trial of the effects of emotion recognition training on mood in a sample of individuals with depressive symptoms over a 6-week follow-up period. Methods/Design: We will recruit 190 adults from the general population who report high levels of depressive symptoms (defined as a score >= 14 on the Beck Depression Inventory-II). Participants will attend a screening session and will be randomised to intervention or control procedures, repeated five times over consecutive days (Monday to Friday). A follow-up session will take place at end-of -treatment, 2-weeks and 6-weeks after training. Our primary study outcome will be depressive symptoms, Beck Depression Inventory- II (rated over the past two weeks). Our secondary outcomes are: depressive symptoms, Hamilton Rating Scale for Depression; anxiety symptoms, Beck Anxiety Inventory (rated over the past month); positive affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); negative affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); emotion sensitivity, Emotion Recognition Task (test phase); approach motivation and persistence, the Fishing Game; and depressive interpretation bias, Scrambled Sentences Test. Discussion: This study is of a novel cognitive bias modification technique that targets biases in emotional processing characteristic of depression, and can be delivered automatically via computer, Internet or Smartphone. It therefore has potential to be a valuable cost-effective adjunctive treatment for depression which may be used together with more traditional psychotherapy, cognitive-behavioural therapy and pharmacotherapy.

  • 2.
    Adhikari, Tara Ballav
    et al.
    Aarhus Univ, Sect Global Hlth, Dept Publ Hlth, Aarhus, Denmark.;Nepal Dev Soc, COBIN Project, Bharatpur, Chitwan, Nepal..
    Neupane, Dinesh
    Nepal Dev Soc, COBIN Project, Bharatpur, Chitwan, Nepal.;Johns Hopkins Univ, Dept Epidemiol, Welch Ctr Prevent Epidemiol & Clin Res, Baltimore, MD USA..
    Karki, Arjun
    HAMS Hosp, Dept Pulm Crit Care & Sleep Med, Kathmandu, Nepal..
    Drews, Arne
    Nepalmed, Leipzig, Germany..
    Cooper, Brendan
    Univ Hosp Birmingham, Lung Funct & Sleep, Birmingham, W Midlands, England..
    Högman, Marieann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Lung- allergy- and sleep research.
    Sigsgaard, Torben
    Aarhus Univ, Sect Environm Occupat & Hlth, Dept Publ Hlth, Aarhus, Denmark..
    Kallestrup, Per
    Aarhus Univ, Sect Global Hlth, Dept Publ Hlth, Aarhus, Denmark..
    Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, article id 474Article in journal (Refereed)
    Abstract [en]

    Background: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, a high prevalence of smoking, and the lack of awareness of COPD make it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level.

    Method: This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12months of FCHVs-led interventions. The difference in the rate of decline of forced expiratory volume in 1s (FEV1) and FEV1/FVC (forced vital capacity) ratio are the primary outcomes and the change in the proportion of modifiable risk factors of COPD, health-related quality of life scores, and change in knowledge of COPD will be secondary outcomes.

    Discussion: This study will estimate the burden of COPD, the magnitude of risk factors and generate evidence to mobilize community health workers for COPD prevention and management at the community level in Nepal.Trial registrationClinicalTrials.gov NCT03797768. Registered on January 9, 2019.

    Download full text (pdf)
    FULLTEXT01
  • 3.
    Adolfsson, Annsofie
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Lindén, Karolina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    Sparud Lundin, Carina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    Larsson, Per-Göran
    Department of Obstetrics and Gynecology, Skaraborg Hospital, Skövde, Sweden.
    Berg, Marie
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for arandomized controlled trial2014In: Trials, E-ISSN 1745-6215, Vol. 15, p. 513-Article in journal (Other academic)
    Abstract [en]

    Background: Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden.

    Methods: The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.

    Discussion: The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management.

  • 4.
    Afsharnejad, Bahareh
    et al.
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Falkmer, Marita
    Jönköping University, School of Education and Communication, HLK, CHILD. Jönköping University, School of Health and Welfare, HHJ. CHILD. School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Black, Melissa H.
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Alach, Tasha
    Autism Association of Western Australia, Perth, WA, Australia.
    Lenhard, Fabian
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Fridell, Anna
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Coco, Christina
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Milne, Kelly
    Autism Association of Western Australia, Perth, WA, Australia.
    Chen, Nigel T. M.
    Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia.
    Bölte, Sven
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Girdler, Sonya
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    KONTAKT© for Australian adolescents on the autism spectrum: Protocol of a randomized control trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, no 1, article id 687Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Individuals diagnosed with autism spectrum disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (1) replication of effects in additional clinical and cultural contexts, (2) designs that employ active control groups, (3) calculation of health economic benefits, (4) identification of the optimal training duration, and (5) measurement of individual goals and quality of life outcomes.

    METHOD/DESIGN:

    With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12-17 years (N = 90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking programme. Participants will attend both programmes in groups of 6-8 adolescents, over 16 one-and-a-half-hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via the Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, and emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and healthcare costs.

    DISCUSSION:

    The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents' personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigorous evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD.

    TRIAL REGISTRATION:

    Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12617001117303. Registered on 31 July 2017. anzctr.org.au ClinicalTrials.gov, NCT03294668. Registered on 22 September 2017. https://clinicaltrials.gov.

  • 5.
    Ahlin, Rebecca
    et al.
    Department of Oncology, Division of Clinical Cancer Epidemiology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.
    Nybacka, Sanna
    Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Josefsson, Andreas
    Umeå University, Faculty of Medicine, Wallenberg Centre for Molecular Medicine at Umeå University (WCMM). Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Urology and Andrology. Department of Urology, Sahlgrenska Cancer Center, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Stranne, Johan
    Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
    Steineck, Gunnar
    Department of Oncology, Division of Clinical Cancer Epidemiology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Box 423, Gothenburg, Sweden.
    Hedelin, Maria
    Department of Oncology, Division of Clinical Cancer Epidemiology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Box 423, Gothenburg, Sweden; Regional Cancer Center West, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
    The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 1041Article in journal (Refereed)
    Abstract [en]

    Background: A high intake of phytoestrogens, found in soy, rye, and seeds, is associated with a reduced risk of a prostate cancer diagnosis. Previously, we found that the overall decreased risk of prostate cancer diagnosis in males with a high intake of phytoestrogens was strongly modified by a nucleotide sequence variant in the estrogen receptor-beta (ERβ) gene. However, we do not know if phytoestrogens can inhibit the growth of prostate cancer in males with established diseases. If there is an inhibition or a delay, there is reason to believe that different variants of the ERβ gene will modify the effect. Therefore, we designed an intervention study to investigate the effect of the addition of foods high in phytoestrogens and their interaction with the ERβ genotype on prostate tumor proliferation in patients with prostate cancer.

    Method: The PRODICA trial is a randomized ongoing intervention study in patients with low- and intermediate-risk prostate cancer with a Gleason score < 8, prostate-specific antigen (PSA) < 20, and scheduled for radical prostatectomy. The study is conducted at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention consists of a daily intake of soybeans and flaxseeds (~ 200 mg of phytoestrogens) until the surgery, approximately 6 weeks. The aim is to recruit 200 participants. The primary outcome is the difference in the proliferation marker Ki-67 between the intervention and the control groups. The genotype of ERβ will be investigated as an effect-modifying factor. Secondary outcomes include, e.g., concentrations of PSA and steroid hormones in the blood.

    Discussion: The results of the PRODICA trial will contribute important information on the relevance of increasing the intake of phytoestrogens in patients with prostate cancer who want to make dietary changes to improve the prognosis of their cancer. If genetic factors turn out to influence the effect of the intervention diet, dietary advice can be given to patients who most likely benefit from it. Dietary interventions are cost-effective, non-invasive, and result in few mild side effects. Lastly, the project will provide basic pathophysiological insights which could be relevant to the development of treatment strategies for patients with prostate cancer.

    Trial registration. ClinicalTrials.gov NCT02759380. Registered on 3 May 2016.

    Download full text (pdf)
    fulltext
  • 6.
    Alimoradi, Z.
    et al.
    Social Determinants of Health Research Center,Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, 34197-59811, Iran.
    Rajabalipour, S.
    Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.
    Rahmani, K.
    Social Determinants of Health Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran.
    Pakpour, Amir H.
    Jönköping University, School of Health and Welfare, HHJ, Dept. of Nursing Science.
    The effect of a social network-based cognitive behavioral therapy intervention on the severity of premenstrual syndrome symptoms: a protocol of a randomized clinical trial study2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 346Article in journal (Refereed)
    Abstract [en]

    Background: Premenstrual syndrome (PMS) is one of the most widespread menstrual disorders in women of reproductive age. This recurrent syndrome is a combination of physically, mentally, or behaviorally disturbing changes occurring during the secretory phase of the menstrual cycle. The aim of this study is to determine the effect of a cognitive-behavioral therapy-based educational intervention using social networks on PMS in female health center employees in Rudbar, Iran. Methods/design: A randomized superiority controlled trial will be conducted involving 140 female employees of health centers affiliated with the Guilan University of Medical Sciences, Rudbar. The study involves a block size of 4 and 6 in a randomly varied order, 140 women who meet all the inclusion criteria will be randomly and equally divided into 2 groups: the intervention and the control groups. Those in the former group will receive a cognitive-behavioral therapy-based treatment for eight consecutive weeks on the social network platform WhatsApp; however, those in the control group will not be offered any treatment except usual care practices (unprotocolized usual care). The study’s primary outcome is the severity of PMS symptoms, and the secondary outcomes include general self-efficacy, work-related quality of life, the impact of PMS on daily life, coping with the symptoms, and experiencing anxiety and depression at the beginning of the study to identify people with PMS. A daily record of the symptoms will be completed for two consecutive months by all female employees aged 20–45 years who wish to participate in the study. According to the initial screening, those with moderate to severe PMS will be included. We will use the MLwin software for the analyses. All questionnaires will be completed by both groups immediately and 8 weeks after the termination of the treatment. The data will be analyzed using linear mixed-effects modeling with random intercepts and slopes. Discussion: It is anticipated that the findings of the present study may demonstrate the effectiveness of the cognitive behavioral therapy intervention on the severity of PMS symptoms that could guide healthcare providers in opting for suitable treatment alternatives for the syndrome. Ethics and dissemination: The research proposal is approved by the Human Ethics Committee of Qazvin University of Medical Sciences (IR.QUMS.REC.1399.252). The results of this intervention trial will be submitted for publication in a peer-reviewed research journal. Trial registration: Iranian Registry of Clinical Trials IRCT20180218038789N4. Registered prospectively on October 28, 2020

  • 7.
    Al-Kaisy, Adnan
    et al.
    St Thomas Hosp, Pain Management & Neuromodulat Ctr, Westminster Bridge Rd, London SE1 7EH, England.
    Royds, Jonathan
    Guys & St Thomas NHS Fdn Trust, London, England.
    Palmisani, Stefano
    Guys & St Thomas NHS Fdn Trust, London, England.
    Pang, David
    Guys & St Thomas NHS Fdn Trust, London, England.
    Wesley, Samuel
    Guys & St Thomas NHS Fdn Trust, London, England.
    Taylor, Rod S.
    Univ Glasgow, Inst Hlth & Well Being, Glasgow, Lanark, Scotland;Univ Exeter, Inst Hlth Res, Med Sch, Exeter, Devon, England.
    Cook, Andrew
    Univ Southampton, Wessex Inst, Southampton, Hants, England;Univ Hosp Southampton NHS Fdn Trust, Southampton, Hants, England.
    Eldabe, Sam
    South Tees Hosp NHS Fdn Trust, Middlesbrough, Cleveland, England.
    McCracken, Lance
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology.
    Duarte, Rui
    Univ Liverpool, Hlth Serv Res, Liverpool Reviews & Implementat Grp, Liverpool, Merseyside, England.
    Fairbank, Jeremy
    Univ Oxford, Oxford, England.
    Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol2020In: Trials, E-ISSN 1745-6215, Vol. 21, article id 111Article in journal (Refereed)
    Abstract [en]

    Introduction: Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.

    Methods: This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.

    Discussion: The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.

    Download full text (pdf)
    FULLTEXT01
  • 8.
    Almeida, Osvaldo P.
    et al.
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia;Royal Perth Hosp, Dept Psychiat, Perth, WA 6000, Australia.
    MacLeod, Colin
    Univ Western Australia, Sch Psychol, Crawley, WA 6009, Australia.
    Ford, Andrew
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia;Royal Perth Hosp, Dept Psychiat, Perth, WA 6000, Australia.
    Grafton, Ben
    Univ Western Australia, Sch Psychol, Crawley, WA 6009, Australia.
    Hirani, Varsha
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia.
    Glance, David
    Univ Western Australia, Ctr Software Practice, Crawley, WA 6009, Australia.
    Holmes, Emily A.
    MRC, Cognit & Brain Sci Unit, Cambridge CB2 7EF, England.
    Cognitive bias modification to prevent depression (COPE): study protocol for a randomised controlled trial2014In: Trials, E-ISSN 1745-6215, Vol. 15, article id 282Article in journal (Refereed)
    Abstract [en]

    Background: Depression is a leading cause of disability worldwide and, although efficacious treatments are available, their efficacy is suboptimal and recurrence of symptoms is common. Effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder, but current options are limited. Cognitive bias modification (CBM) is a novel, simple, and safe intervention that addresses attentional and interpretive biases associated with anxiety, dysphoria, and depression. The primary aim of this trial is to determine if CBM decreases the one-year onset of a major depressive episode among adults with subsyndromal depression. Design and methods: This randomised controlled trial will recruit 532 adults with subsyndromal symptoms of depression living in the Australian community (parallel design, 1:1 allocation ratio). Participants will be free of clinically significant symptoms of depression and of psychotic disorders, sensory and cognitive impairment, and risky alcohol use. The CBM intervention will target attentional and interpretive biases associated with depressive symptoms. The sessions will be delivered via the internet over a period of 52 weeks. The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria over a 12-month period. Secondary outcomes of interest include change in the severity of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9), use of antidepressants or benzodiazepines, and changes in attention and interpretive biases. The assessment of outcomes will take place 3, 6, 9, and 12 months after randomisation and will occur via the internet. Discussion: We propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available. The intervention is simple, inexpensive, easy to access, and could be easily rolled out into practice if our findings confirm a role for CBM in the prevention of depression.

  • 9.
    Anandavadivelan, Poorna
    et al.
    Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institute, Stockholm, Sweden.
    Cardinale, Daniele A.
    Swedish School of Sport and Health Sciences, GIH, Department of Physiology, Nutrition and Biomechanics. Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institute, Stockholm, Sweden.
    Blomhoff, Rune
    Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway..
    Sunde, Berit
    Division of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institute, Solna, Sweden; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden..
    Lassen, Kristoffer
    Department of Hepatobiliary and Pancreatic Surgery, Oslo University Hospital, Oslo, Norway.
    Kleive, Dyre
    Department of Hepatobiliary and Pancreatic Surgery, Oslo University Hospital, Oslo, Norway.
    Sturesson, Christian
    Division of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institute, Solna, Sweden; Department of HPB Surgery, Karolinska University Hospital, Stockholm, Sweden.
    Gilg, Stefan
    Division of Surgery, Department of Clinical Science, Intervention and Technology, Karolinska Institute, Solna, Sweden; Department of HPB Surgery, Karolinska University Hospital, Stockholm, Sweden.
    Raastad, Truls
    Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway..
    Mijwel, Sara
    Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institute, Stockholm, Sweden; Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway..
    Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial.2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 356Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Patients diagnosed with pancreatic, biliary tract, and liver cancer often suffer from a progressive loss of muscle mass. Given the considerable functional impairments in these patients, high musculoskeletal weight loads may not be well tolerated by all individuals. The use of blood-flow restricted resistance training (BFR-T) which only requires low training loads may allow for a faster recovery of muscle due to avoidance of high levels of mechanical muscle stress associated with high-load resistance exercise. This study aims to investigate whether BFR-T can prevent or slow down the loss of skeletal muscle mass and enhance the functional capacity and mental health of patients with pancreatic, biliary tract, and liver cancer.

    METHODS: The PREV-Ex exercise trial is a multicenter two-armed randomized controlled trial. Patients will be randomized to an exercise program consisting of home-based low-load BFR-T during a combined pre- and postoperative period for a total of 6-10 weeks (prehabilitation and rehabilitation), or to a control group. Protein supplementation will be given to both groups to ensure adequate protein intake. The primary outcomes, skeletal muscle thickness and muscle cross-sectional area, will be assessed by ultrasound. Secondary outcomes include the following: (i) muscle catabolism-related and inflammatory bio-markers (molecular characteristics will be assessed from a vastus lateralis biopsy and blood samples will be obtained from a sub-sample of patients); (ii) patient-reported outcome measures (self-reported fatigue, health-related quality of life, and nutritional status will be assessed through validated questionnaires); (iii) physical fitness/performance/activity (validated tests will be used to evaluate physical function, cardiorespiratory fitness and maximal isometric muscle strength. Physical activity and sedentary behavior (assessed using an activity monitor); (iv) clinical outcomes: hospitalization rates and blood status will be recorded from the patients' medical records; (v) explorative outcomes of patients' experience of the exercise program which will be evaluated using focus group/individual interviews.

    DISCUSSION: It is worthwhile to investigate new strategies that have the potential to counteract the deterioration of skeletal muscle mass, muscle function, strength, and physical function, all of which have debilitating consequences for patients with pancreatic, biliary tract, and liver cancer. The expected findings could improve prognosis, help patients stay independent for longer, and possibly reduce treatment-related costs.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT05044065. Registered on September 14, 2021.

    Download full text (pdf)
    fulltext
  • 10.
    Andren, Per
    et al.
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    de la Cruz, Lorena Fernandez
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Isomura, Kayoko
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Lenhard, Fabian
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Hall, Charlotte L.
    Univ Nottingham, Inst Mental Hlth Mental Hlth & Clin Neurosci, Nottingham, England.;Univ Nottingham, Inst Mental Hlth, Sch Med Mental Hlth & Clin Neurosci, NIHR MindTech MedTech Cooperat, Innovat Park,Triumph Rd, Nottingham, England..
    Davies, E. Bethan
    Univ Nottingham, Inst Mental Hlth Mental Hlth & Clin Neurosci, Nottingham, England.;Univ Nottingham, Inst Mental Hlth, Sch Med Mental Hlth & Clin Neurosci, NIHR MindTech MedTech Cooperat, Innovat Park,Triumph Rd, Nottingham, England..
    Murphy, Tara
    UCL Great Ormond St Inst Child Hlth ICH, 30 Guilford St, London WC1N 1EH, England.;Great Ormond St Hosp Children NHS Fdn Trust, Psychol & Mental Hlth Serv, Great Ormond St, London, England..
    Hollis, Chris
    Univ Nottingham, Inst Mental Hlth Mental Hlth & Clin Neurosci, Nottingham, England.;Univ Nottingham, Inst Mental Hlth, Sch Med Mental Hlth & Clin Neurosci, NIHR MindTech MedTech Cooperat, Innovat Park,Triumph Rd, Nottingham, England.;Univ Nottingham, Div Psychiat & Appl Psychol, Inst Mental Hlth, NIHR Nottingham Biomed Res Ctr, Nottingham, England..
    Sampaio, Filipa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    Feldman, Inna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    Bottai, Matteo
    Karolinska Inst, Inst Environm Med, Unit Biostat, Stockholm, Sweden..
    Serlachius, Eva
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Andersson, Erik
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Mataix-Cols, David
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Gävlegatan 22, S-11330 Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, article id 669Article in journal (Refereed)
    Abstract [en]

    Background: Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists and long travel distances to specialist clinics. Internet-delivered BT has the potential of overcoming these barriers through remote delivery of treatment with minimal therapist support. In the current protocol, we outline the design and methods of a randomised controlled trial (RCT) evaluating an internet-delivered BT programme referred to as BIP TIC. The trial's primary objective is to determine the clinical efficacy of BIP TIC for reducing tic severity in young people with TS/CTD, compared with an active control intervention. Secondary objectives are to investigate the 12-month durability of the treatment effects and to perform a health economic evaluation of the intervention.

    Methods: In this single-blind superiority RCT, 220 participants (9-17 years) with TS/CTD throughout Sweden will be randomised to 10-12 weeks of either therapist-supported internet-delivered BT based on exposure with response prevention (BIP TIC) or therapist-supported internet-delivered education. Data will be collected at baseline, 3 and 5 weeks into the treatment, at post-treatment, and 3, 6, and 12 months post-treatment. The primary endpoint is the 3-month follow-up. The primary outcome is tic severity as measured by the Yale Global Tic Severity Scale - Total Tic Severity Score. Treatment response is operationalised as scores of "Very much improved" or "Much improved" on the Clinical Global Impression - Improvement scale, administered at the primary endpoint. Outcome assessors will be blind to treatment condition at all assessment points. A health economic evaluation of BIP TIC will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up). There are no planned interim analyses.

    Discussion: Participant recruitment started on 26 April 2019 and finished on 9 April 2021. The total number of included participants was 221. The final participant is expected to reach the primary endpoint in September 2021 and the 12-month follow-up in June 2022. Data analysis for the primary objective will commence after the last participant reaches the primary endpoint.

    Download full text (pdf)
    FULLTEXT01
  • 11.
    Arvidson, Elin
    et al.
    The Institute of Stress Medicine, Västra götalandsregionen, Sweden.
    Sjörs Dahlman, Anna
    Swedish National Road and Transport Research Institute, Traffic and road users, The Human in the Transport system.. The Institute of Stress Medicine, Västra götalandsregionen, Sweden.
    Börjesson, Mats
    University of Gothenburg.
    Gullstrand, Lennart
    University of Gothenburg.
    Jonsdottir, Ingibjörg H.
    University of Gothenburg.
    The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress: a randomized controlled study2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 888Article in journal (Refereed)
    Abstract [en]

    Background: Exercise training is suggested to have a stress-buffering effect on physiological reactions to acute stress. The so-called cross-stressor adaptation hypothesis is one of many theories behind the plausible effects, proposing that the attenuated physiological reaction seen in trained individuals in response to acute exercise is also seen when the individual is exposed to acute psychosocial stress. However, few randomized controlled trials (RCT) are available in this field. Therefore, the aim of the present trial was to study the effects of a 6-month aerobic exercise intervention on the physiological response to acute laboratory stress.

    Methods: A two-armed RCT including untrained but healthy individuals aged 20–50 years was conducted. Assessments included a peak oxygen uptake test and a psychosocial stress test (the Trier Social Stress Test). A total of 88 participants went through both baseline and follow-up measures (48 in the intervention group and 40 in the control group) with a similar proportion of women and men (20 women and 28 men in the intervention group and 18 women and 22 men in the control group). Outcome measures were adrenocorticotrophic hormone, cortisol, systolic and diastolic blood pressure, and heart rate responses to acute psychosocial stress.

    Results: Oxygen uptake and time-to-exhaustion increased significantly following the intervention, while a decrease was seen in the control group. The analyses showed attenuated responses to acute psychosocial stress for all variables in both groups at follow-up, with no differences between the groups. No correlation was seen between amount of exercise training and reactivity to the stress test. Despite the increased oxygen uptake in the intervention group, no differences were seen between the groups for any of the outcome variables at follow-up.

    Conclusions: In this study, the cross-stressor adaptation hypothesis could not be confirmed. Both groups showed decreased reactions indicating a habituation to the stress test.

    Trial registration: ClinicalTrials.gov NCT02051127. Registered on 31 January 2014—retrospectively registered.

    Download full text (pdf)
    fulltext
  • 12. Atuhairwe, Susan
    et al.
    Byamugisha, Josaphat
    Klingberg-Allvin, Marie
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Cleeve, Amanda
    Hanson, Claudia
    Tumwesigye, Nazarius Mbona
    Kakaire, Othman
    Danielsson, Kristina Gemzell
    Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, no 1, article id 376Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians.

    METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 μg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant.

    DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

    Download full text (pdf)
    fulltext
  • 13.
    Bartha, Erzsebet
    et al.
    Karolinska University Hospital, Sweden.
    Davidson, Thomas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Brodtkorb, Thor-Henrik
    RTI Health Solut, Sweden.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Kalman, Sigridur
    Karolinska University Hospital, Sweden.
    Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients2013In: Trials, E-ISSN 1745-6215, Vol. 14Article in journal (Refereed)
    Abstract [en]

    Background

    A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation’s main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed.

    Methods

    A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society’s willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT.

    Results

    If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society’s willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million.

    Conclusions

    If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as ‘further research is needed’ are replaced with ‘further research is cost-effective and ‘further funding of a trial is justified’.

    Download full text (pdf)
    fulltext
  • 14.
    Bartley, Andreas
    et al.
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden..
    Jakola, Asgeir S.
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden.;St Olavs Hosp, Dept Neurosurg, N-7006 Trondheim, Norway..
    Bartek, Jiri, Jr.
    Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden.;Rigshosp, Dept Neurosurg, Copenhagen Univ Hosp, Copenhagen, Denmark..
    Sundblom, Jimmy
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
    Förander, Petter
    Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden..
    Marklund, Niklas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
    Tisell, Magnus
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden..
    The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial2017In: Trials, E-ISSN 1745-6215, Vol. 18, article id 471Article in journal (Refereed)
    Abstract [en]

    Background: Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5-30% of patients, is a major clinical problem. The temperature of the irrigation fluid used during evacuation of the hematoma might theoretically influence recurrence rates since irrigation fluid at body temperature (37 degrees C) may beneficially influence coagulation and cSDH solubility when compared to irrigation fluid at room temperature. Should no difference in recurrence rates be observed when comparing irrigation-fluid temperatures, there is no need for warmed fluids during surgery. Our main aim is to investigate the effect of irrigation-fluid temperature on recurrence rates and clinical outcomes after cSDH evacuation using a multicenter randomized controlled trial design.

    Methods: The study will be conducted in three neurosurgical departments with population-based catchment areas using a similar surgical strategy. In total, 600 patients fulfilling the inclusion criteria will randomly be assigned to either intraoperative irrigation with fluid at body temperature or room temperature. The power calculation is based on a retrospective study performed at our department showing a recurrence rate of 5% versus 12% when comparing irrigation fluid at body temperature versus fluid at room temperature (unpublished data). The primary endpoint is recurrence rate of cSDH analyzed at 6 months post treatment. Secondary endpoints are mortality rate, complications and health-related quality of life.

    Discussion: Irrigation-fluid temperature might influence recurrence rates in the evacuation of chronic subdural hematomas. We present a study protocol for a multicenter randomized controlled trial investigating our hypothesis that irrigation fluid at body temperature is superior to room temperature in reducing recurrence rates following evacuation of cSDH.

    Download full text (pdf)
    fulltext
  • 15.
    Bejerholm, Ulrika
    et al.
    Lund Univ, Med Fac, Dept Hlth Sci, Lund, Sweden.;Reg Skane Cty, Div Psychiat Habilitat & Aids, Lund, Sweden..
    Hakansson, Anders
    Reg Skane Cty, Div Psychiat Habilitat & Aids, Lund, Sweden.;Lund Univ, Med Fac, Dept Clin Sci, Lund, Sweden..
    Knutagård, Marcus
    Lund Univ, Dept Social Sci, Sch Social Sci, Lund, Sweden..
    Hillborg, Helene
    Lund Univ, Med Fac, Dept Hlth Sci, Lund, Sweden.;Study Mid Sweden Univ, Sundsvall, Sweden.;Reg Vasternorrland Cty, Dept Res & Dev, Sundsvall, Sweden..
    Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 222Article in journal (Refereed)
    Abstract [en]

    Background: Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. However, the unemployment situation for this group reflects the knowledge gap in effective interventions to support employment. While Individual Placement and Support (IPS) is recognised as evidence-based supported employment for those with serious mental health problems, no scientific evidence for the target group of addiction exists to date. The aim of the present IPS for Alcohol and Drug Addiction in Sweden (IPS-ADAS) trial is to study whether IPS has an effect on gaining employment for this group. Methods: The IPS-ADAS trial is a multisite, pragmatic, parallel, and single-blinded, superiority randomised controlled trial (RCT). Participants (N = 330) will be randomly assigned (1:1) and participate in IPS plus treatment as usual within Addiction Services (IPS + TAU) or Traditional Vocational Rehabilitation (TVR) available plus TAU (TVR + TAU) for 12 months. The principle of intention-to-treat (ITT) will be applied. The hypothesis is that a significantly larger proportion of IPS + TAU participants will be employed for > 1 day (primary outcome), reach employment sooner, work more hours and longer periods of time, and have a higher income as compared to TVR + TAU participants at 18-month follow-up. We further anticipate that those who benefit from IPS + TAU will use less alcohol and drugs, experience better health, and use less care and support, including support from the justice system, in comparison to TVR + TAU participants, at 6, 12, and 18 months. A supplementary process evaluation, using the IPS Fidelity Scale (25 items) and adhered interviews will address delivery and receipt of the IPS as well as contextual hinders and barriers for coproduction and implementation. Working age (18-65), willingness to work, unemployment, participation in an information meeting about the RCT, treatment for addiction diagnosis, and being financially supported by welfare, constitute eligible criteria. Discussion: A primary study on the effectiveness of IPS on employment for the new target group of addictions will add to the international IPS knowledge base and inform national policy to include the underrepresented group in working life.

  • 16. Bejerholm, Ulrika
    et al.
    Håkansson, Anders
    Knutagård, Marcus
    Hillborg, Helene
    Mid Sweden University, Faculty of Human Sciences, Department of Health Sciences (HOV). Lund University; Region Västernorrland County, Sundsvall.
    Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 222Article in journal (Refereed)
    Abstract [en]

    Background: Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. However, the unemployment situation for this group reflects the knowledge gap in effective interventions to support employment. While Individual Placement and Support (IPS) is recognised as evidence-based supported employment for those with serious mental health problems, no scientific evidence for the target group of addiction exists to date. The aim of the present IPS for Alcohol and Drug Addiction in Sweden (IPS-ADAS) trial is to study whether IPS has an effect on gaining employment for this group. Methods: The IPS-ADAS trial is a multisite, pragmatic, parallel, and single-blinded, superiority randomised controlled trial (RCT). Participants (N = 330) will be randomly assigned (1:1) and participate in IPS plus treatment as usual within Addiction Services (IPS + TAU) or Traditional Vocational Rehabilitation (TVR) available plus TAU (TVR + TAU) for 12 months. The principle of intention-to-treat (ITT) will be applied. The hypothesis is that a significantly larger proportion of IPS + TAU participants will be employed for > 1 day (primary outcome), reach employment sooner, work more hours and longer periods of time, and have a higher income as compared to TVR + TAU participants at 18-month follow-up. We further anticipate that those who benefit from IPS + TAU will use less alcohol and drugs, experience better health, and use less care and support, including support from the justice system, in comparison to TVR + TAU participants, at 6, 12, and 18 months. A supplementary process evaluation, using the IPS Fidelity Scale (25 items) and adhered interviews will address delivery and receipt of the IPS as well as contextual hinders and barriers for coproduction and implementation. Working age (18–65), willingness to work, unemployment, participation in an information meeting about the RCT, treatment for addiction diagnosis, and being financially supported by welfare, constitute eligible criteria. Discussion: A primary study on the effectiveness of IPS on employment for the new target group of addictions will add to the international IPS knowledge base and inform national policy to include the underrepresented group in working life. Trial registration: WHO International Clinical Trials Registry Platform ISRCTN10492363. Registered on 14 August 2023. 

    Download full text (pdf)
    fulltext
  • 17.
    Bergh, Cecilia
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Landberg, Rikard
    Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden; Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Andersson, Kristina
    Department of Experimental Medical Science, Lund University, Lund, Sweden; Glucanova AB, Lund, Sweden.
    Heyman-Lindén, Lovisa
    Molecular Nutrition, Department of Experimental Medical Science, Lund University, Lund, Sweden; Berry Lab AB, Lund, Sweden.
    Rascón, Ana
    Glucanova AB, Lund, Sweden; Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.
    Magnuson, Anders
    School of Medical Sciences, Örebro University, Örebro, Sweden.
    Khalili, Payam
    Department of Cardiology and Acute Internal Medicine, Central Hospital, Karlstad, Sweden.
    Kåregren, Amra
    Department of Medicine, Hospital Region Västmanland, Västerås, Sweden.
    Nilsson, Johan
    Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Pirazzi, Carlo
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology.
    Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 338Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI.

    METHODS: The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months.

    DISCUSSION: Controlling hyperlipidemia and inflammation is critical to preventing new cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention after AMI.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03620266 . Registered on August 8, 2018.

  • 18.
    Bergh, Cecilia
    et al.
    Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden.
    Landberg, Rikard
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Section of Medicine. Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.
    Andersson, Kristina
    Department of Experimental Medical Science, Lund University, Lund, Sweden; Glucanova AB, Lund, Sweden.
    Heyman-Lindén, Lovisa
    Molecular Nutrition, Department of Experimental Medical Science, Lund University, Lund, Sweden; Berry Lab AB, Lund, Sweden.
    Rascón, Ana
    Glucanova AB, Lund, Sweden; Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden.
    Khalili, Payam
    Department of Cardiology and Acute Internal Medicine, Central Hospital, Karlstad, Sweden.
    Kåregren, Amra
    Department of Medicine, Hospital Region Västmanland, Västerås, Sweden.
    Nilsson, Johan
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Section of Medicine.
    Pirazzi, Carlo
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Fröbert, Ole
    Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 338Article in journal (Refereed)
    Abstract [en]

    Background: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI.

    Methods: The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months.

    Discussion: Controlling hyperlipidemia and inflammation is critical to preventing new cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention after AMI.

    Trial registration: ClinicalTrials.gov NCT03620266. Registered on August 8, 2018.

    Download full text (pdf)
    fulltext
  • 19. Berglind, Daniel
    et al.
    Nyberg, Gisela
    Karolinska Institutet, Stockholm, Sweden.
    Willmer, Mikaela
    Persson, Margareta
    Wells, Michael
    Forsell, Yvonne
    An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.2018In: Trials, E-ISSN 1745-6215, Vol. 19, no 1, article id 258Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors.

    METHODS: The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability.

    DISCUSSION: There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1).

    TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.

  • 20. Berglind, Daniel
    et al.
    Nyberg, Gisela
    Willmer, Mikaela
    Persson, Margareta
    Umeå University, Faculty of Medicine, Department of Nursing.
    Wells, Michael
    Forsell, Yvonne
    An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial2018In: Trials, E-ISSN 1745-6215, Vol. 19, article id 258Article in journal (Refereed)
    Abstract [en]

    Background: Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. 

    Methods: The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability.

    Discussion: There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1).

    Download full text (pdf)
    fulltext
  • 21.
    Berglind, Daniel
    et al.
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Nyberg, Gisela
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Willmer, Mikaela
    University of Gävle, Faculty of Health and Occupational Studies, Department of Health and Caring Sciences, Caring science.
    Persson, Margareta
    Department of Nursing, Umeå Universiy, Umeå, Sweden.
    Wells, Michael
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Forsell, Yvonne
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.2018In: Trials, E-ISSN 1745-6215, Vol. 19, no 1, article id 258Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors.

    METHODS: The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability.

    DISCUSSION: There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1).

    TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.

  • 22. Bergman Nordegren, Lise
    et al.
    Andersson, Gerhard
    Kadowaki, Åsa
    Carlbring, Per
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, p. 16-Article in journal (Refereed)
    Abstract [en]

    Background: Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and comorbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group.

    Methods: Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment.

    Discussion: This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial Registration: ClinicalTrials.gov: NCT01390168

    Download full text (pdf)
    Tailored internet
  • 23.
    Bergman Nordgren, Lise
    et al.
    Linköping University, Linköping, Sweden.
    Andersson, Gerhard
    Karolinska Institutet, Stockholm, Sweden; Linköping University, Linköping, Sweden.
    Kadowaki, Åsa
    County council of Östergötland, Linköping, Sweden.
    Carlbring, Per
    Umeå University, Umeå, Sweden.
    Tailored internet-administered treatment of anxiety disorders for primary care patients: Study protocol for a randomised controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 1, article id 16Article in journal (Refereed)
    Abstract [en]

    Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients ClinicalTrials.gov: NCT01390168.

  • 24.
    Bergman Nordgren, Lise
    et al.
    Linköping University, Department of Behavioural Sciences and Learning. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Clinical and Social Psychology. Linköping University, Faculty of Arts and Sciences.
    Kadowaki, Åsa
    Linköping University, Department of Social and Welfare Studies. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Psychiatry.
    Carlbring, Per
    Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 1, p. 16-Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. METHODS: Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. DISCUSSION: This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial registration: Clinical trials identifier NCT01390168.

    Download full text (pdf)
    fulltext
  • 25.
    Berman, Anne H.
    et al.
    Uppsala Univ, Sweden; Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden.
    Topooco, Naira
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Uppsala Univ, Sweden.
    Lindfors, Petra
    Stockholm Univ, Sweden.
    Bendtsen, Marcus
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Lindner, Philip
    Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden.
    Molander, Olof
    Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden.
    Kraepelien, Martin
    Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden.
    Sundstrom, Christopher
    Uppsala Univ, Sweden; Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden.
    Talebizadeh, Nooshin
    Uppsala Univ, Sweden.
    Engstroem, Karin
    Karolinska Inst, Sweden.
    Vlaescu, George
    Linköping University, Department of Behavioural Sciences and Learning. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Karolinska Inst, Sweden; Stockholm Hlth Care Serv, Sweden; Malmo Univ, Sweden.
    Andersson, Claes
    Uppsala Univ, Sweden.
    Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 158Article in journal (Refereed)
    Abstract [en]

    BackgroundEmerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components.MethodsThis study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned.DiscussionThis study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.

  • 26. Berman, Anne H.
    et al.
    Topooco, Naira
    Lindfors, Petra
    Stockholm University, Faculty of Social Sciences, Department of Psychology, Work and organizational psychology. Stockholm University, Faculty of Social Sciences, Department of Education.
    Bendtsen, Marcus
    Lindner, Philip
    Molander, Olof
    Kraepelien, Martin
    Sundström, Christopher
    Talebizadeh, Nooshin
    Engström, Karin
    Vlaescu, George
    Andersson, Gerhard
    Andersson, Claes
    Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 158Article in journal (Refereed)
    Abstract [en]

    Background: Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components.

    Methods: This study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned.

    Discussion: This study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.

  • 27.
    Berman, Anne H.
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology. Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Topooco, Naira
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology. Linköping Univ, Dept Behav Sci & Learning, Dept Biomed & Clin Sci, Linköping, Sweden..
    Lindfors, Petra
    Stockholm Univ, Dept Psychol, Stockholm, Sweden..
    Bendtsen, Marcus
    Linköping Univ, Dept Hlth Med & Caring Sci, Linköping, Sweden..
    Lindner, Philip
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Reg Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Reg Stockholm, Sweden..
    Molander, Olof
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Reg Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Reg Stockholm, Sweden..
    Kraepelien, Martin
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Reg Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Reg Stockholm, Sweden..
    Sundström, Christopher
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology. Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
    Talebizadeh, Nooshin
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology.
    Engström, Karin
    Karolinska Inst, Dept Global Publ Hlth, Solna, Sweden..
    Vlaescu, George
    Linköping Univ, Dept Behav Sci & Learning, Dept Biomed & Clin Sci, Linköping, Sweden..
    Andersson, Gerhard
    Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden;Reg Stockholm, Hlth Care Serv, Stockholm, Sweden.;Linköping Univ, Dept Behav Sci & Learning, Dept Biomed & Clin Sci, Linköping, Sweden..
    Andersson, Claes
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology. Department of Criminology, Malmö University, Malmö, Sweden.
    Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 158Article in journal (Refereed)
    Abstract [en]

    BackgroundEmerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components.MethodsThis study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned.DiscussionThis study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.

    Download full text (pdf)
    FULLTEXT01
  • 28.
    Berman, Anne H
    et al.
    Department of Psychology, Uppsala University, Uppsala, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
    Topooco, Naira
    Department of Psychology, Uppsala University, Uppsala, Sweden; Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
    Lindfors, Petra
    Department of Psychology, Stockholm University, Stockholm, Sweden.
    Bendtsen, Marcus
    Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
    Lindner, Philip
    Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
    Molander, Olof
    Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
    Kraepelien, Martin
    Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
    Sundström, Christopher
    Department of Psychology, Uppsala University, Uppsala, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
    Talebizadeh, Nooshin
    Department of Psychology, Uppsala University, Uppsala, Sweden.
    Engström, Karin
    Department of Global Public Health, Karolinska Institutet, Solna, Sweden.
    Vlaescu, George
    Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
    Andersson, Gerhard
    Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden; Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
    Andersson, Claes
    Malmö University, Faculty of Health and Society (HS), Department of Criminology (KR). Department of Psychology, Uppsala University, Uppsala, Sweden.
    Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 158Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components.

    METHODS: This study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned.

    DISCUSSION: This study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.

    Download full text (pdf)
    fulltext
  • 29.
    Bertuzzi, Vanessa
    et al.
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Semonella, Michelle
    Department of Psychology, Bar-Ilan University, 52900, Ramat-Gan, Israel.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Department of Clinical Neuroscience, Karolinska Institute, Solna, Sweden.
    Manzoni, Gian Mauro
    Department of Psychology, Faculty of Psychology, eCampus University, 22100, Como, Italy.
    Castelnuovo, Gianluca
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Molinari, Enrico
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Pietrabissa, Giada
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project.2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 801Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: This study aims to evaluate the feasibility and effectiveness of the RinasciMENTE program, an Internet-based self-help intervention based on cognitive behavioral therapy (CBT) principles and techniques in supporting individuals experiencing psychological impairments during the COVID-19 pandemic. A randomized controlled trial (RCT) design with random allocation at the level of individual will be conducted to compare the impact of the RinasciMENTE program with a waiting list control in improving the psychological functioning of the general population during the COVID-19 pandemic.

    METHODS: A minimum sample of 128 participants experiencing mild/subthreshold levels of psychological symptoms during the COVID-19 pandemic will be recruited. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 2 months, during which participants will receive 8 weekly CBT treatment modules. The impact of the RinasciMENTE program on selected primary and secondary psychological outcomes will be tested at the end of the intervention (2 months) and 6- and 12-month follow-ups.

    DISCUSSION: We expect people to show an increased level of psychological functioning and to acquire the skills and self-confidence necessary to deal with the psychological consequences of the COVID-19 outbreak and its related social isolation during and following the pandemic.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT0497903 Registered on 28 May 2021.

    Download full text (pdf)
    fulltext
  • 30.
    Beukes, Eldre W.
    et al.
    Anglia Ruskin University, England.
    Baguley, David M.
    Anglia Ruskin University, England; Nottingham Biomed Research Centre, England; University of Nottingham, England.
    Allen, Peter M.
    Anglia Ruskin University, England; Anglia Ruskin University, England.
    Manchaiah, Vinaya
    Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research. Lamar University, TX 77710 USA; Audiol India, India; Manipal University, India.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institute, Sweden.
    Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial2017In: Trials, E-ISSN 1745-6215, Vol. 18, article id 186Article in journal (Refereed)
    Abstract [en]

    Background: Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. Methods/design: This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. Discussion: This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems.

    Download full text (pdf)
    fulltext
  • 31.
    Björnsson, Bergthor
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Sandström, Per
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Lindhoff Larsson, Anna
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Hjalmarsson, Claes
    Blekinge Hosp, Sweden; Lund Univ, Sweden.
    Gasslander, Thomas
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, article id 356Article in journal (Refereed)
    Abstract [en]

    BackgroundEarlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only one randomized study has been conducted showing reduced time to functional recovery after LDP compared with ODP.MethodsLAPOP is a prospective randomized, nonblinded, parallel-group, single-center superiority trial. Sixty patients with lesions in the pancreatic body or tail that are found by a multidisciplinary tumor board to need surgical resection will be randomized to receive LDP or ODP. The primary outcome variable is postoperative hospital stay, and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids and as the ability of an ambulatory patient to perform activities of daily life), perioperative bleeding, complications, need for pain medication, and quality of life comparison.DiscussionThe LAPOP trial will test the hypothesis that LDP reduces postoperative hospital stay compared with ODP.Trial registrationISRCTN, 26912858. Registered on 28 September 2015.

    Download full text (pdf)
    fulltext
  • 32.
    Blom, Lisa
    et al.
    Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
    Edenius, Anna
    Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
    Enebrink, Pia
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
    Hjern, Anders
    Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Åhlén, Johan
    Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
    Bergström, Malin
    Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
    Lindberg, Lene
    Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
    Little All Children in Focus (Little ACF), evaluation of a parental support program for parents of children aged 1–2 years: study protocol for a randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 184Article in journal (Refereed)
    Abstract [en]

    Background: Child health and development can be promoted by strengthening and supporting parents. Research on parental support programs based on positive psychology and a health-promoting approach aimed at all parents, and in particular parents of infants is limited. All Children in Focus (ACF) is a parental support program that has been evaluated in a randomized trial in parents of children 3–12 years. The ACF is based on health promotion aiming to increase parents’ confidence and child’s well-being. In the current study, we will study the effects of a revised version of the ACF called Little ACF adapted to parents with children aged 1–2 years.

    Methods: The study includes a randomized controlled trial (RCT) taking place at several Child Health Centers (CHCs) in Sweden. The RCT will evaluate the efficacy of Little ACF (intervention) in comparison with four digital lectures about child development and parenting (active control). Parents are recruited at the 10-, 12-, or 18-month visits to CHC by CHC-nurses. Data to assess changes in parental competencies and child socio-emotional development are collected through online questionnaires completed by parents at five time points: baseline, post-intervention, after 6 and 12 months, and when the child is 3 years old.

    Discussion: The paper describes a study protocol of a randomized controlled trial evaluating the effects of a parental support program during infancy. Several issues related to the methodology and implementation are discussed.

    Trial registration: ClinicalTrials.gov NCT05445141. Registered on 6 July 2022.

    Download full text (pdf)
    fulltext
  • 33.
    Bluth, T.
    et al.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Teichmann, R.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Kiss, T.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Bobek, I.
    Semmelweis Egyet, Aneszteziol & Intenz Terapias Klin, Budapest, Hungary..
    Canet, J.
    Hosp Badalona Germans Trias & Pujol, Dept Anesthesiol, Badalona, Spain..
    Cinnella, G.
    Univ Foggia, Dept Anesthesiol & Intens Care Med, Foggia, Italy..
    De Baerdemaeker, L.
    Univ Ghent, Dept Anesthesiol, Ghent, Belgium..
    Gregoretti, C.
    Policlin P Giaccone, Dept Biopathol & Med Biotechnol, Palermo, Italy..
    Hedenstierna, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Hemmes, S. N.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Hiesmayr, M.
    Med Univ Vienna, Div Cardiac Surg, Vienna, Austria.;Med Univ Vienna, Div Thorac Dis, Vienna, Austria.;Med Univ Vienna, Div Vasc Surg, Vienna, Austria.;Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria..
    Hollmann, M. W.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Jaber, S.
    St Eloi Univ Hosp, Dept Crit Care Med & Anesthesiol SAR B, Montpellier, France..
    Laffey, J. G.
    St Michaels Hosp, Dept Anesthesia, Crit Care Med Program, Toronto, ON, Canada.;Univ Toronto, Dept Anesthesia, Toronto, ON, Canada.;Univ Toronto, Dept Physiol, Toronto, ON, Canada.;Univ Toronto, Interdepartmental Div Crit Care Med, Toronto, ON, Canada..
    Licker, M. J.
    Univ Hosp Geneva, Dept Anesthesiol Pharmacol & Intens Care, Geneva, Switzerland..
    Markstaller, K.
    Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria..
    Matot, I.
    Tel Aviv Univ, Sackler Sch Med, Tel Aviv Med Ctr, Dept Anesthesia & Crit Care, Tel Aviv, Israel..
    Mueller, G.
    Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany..
    Mills, G. H.
    Sheffield Teaching Hosp, OSCCA, Sheffield, S Yorkshire, England.;Univ Sheffield, Sheffield, S Yorkshire, England..
    Mulier, J. P.
    AZ Sint Jan Brugge Oostende AV, Dept Anesthesiol, Brugge, Belgium..
    Putensen, C.
    Univ Bonn, Dept Anesthesiol & Intens Care Med, Bonn, Germany..
    Rossaint, R.
    Univ Aachen, Dept Anesthesiol, Aachen, Germany..
    Schmitt, J.
    Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany..
    Senturk, M.
    Istanbul Univ, Istanbul Fac Med, Dept Anesthesiol & Intens Care Med, Istanbul, Turkey..
    Serpa Neto, A.
    Fac Med ABC, Hosp Israelita Albert Einstein, Dept Crit Care Med, Sao Paulo, Brazil.;Fac Med ABC, Program Postgrad Res & Innovat, Sao Paulo, Brazil..
    Severgnini, P.
    Univ Insubria, Dept Biotechnol & Sci Life, ASST Sette Laghi, Osped Cricolo & Fdn Macchi, Varese, Italy..
    Sprung, J.
    Mayo Clin, Dept Anesthesiol, Rochester, MN USA..
    Melo, M. F. Vidal
    Massachusetts Gen Hosp, Harvard Med Sch, Dept Anesthesia Crit Care & Pain Med, Boston, MA 02114 USA..
    Wrigge, H.
    Univ Leipzig, Dept Anesthesiol & Intens Care Med, Leipzig, Germany..
    Schultz, M. J.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Pelosi, P.
    Univ Genoa, IRCCS AOU San Martino IST, Dept Surg Sci & Integrated Diagnost, Genoa, Italy..
    de Abreu, M. Gama
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial2017In: Trials, E-ISSN 1745-6215, Vol. 18, article id 202Article in journal (Refereed)
    Abstract [en]

    Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.

    Methods/design: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index >= 35 kg/m(2) scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH(2)O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH(2)O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.

    Discussion: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.

    Download full text (pdf)
    fulltext
    Download (pdf)
    errata
  • 34.
    Boettcher, Johanna
    et al.
    Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Department of Psychology, Stockholm University, Sweden.
    Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 1, p. 68-Article in journal (Refereed)
    Abstract [en]

    Background

    Guided Internet-based cognitive-behavioral therapy (ICBT) has been found to be effective for social anxiety disorder (SAD) by several independent research groups. However, since the extent of clinically significant change demonstrated leaves room for improvement, new treatments should be developed and investigated. A novel treatment, which has generally been found to be effective, is cognitive bias modification (CBM). This study aims to evaluate the combination of CBM and ICBT. It is intended that two groups will be compared; one group randomized to receiving ICBT and CBM towards threat cues and one group receiving ICBT and control training. We hypothesize that the group receiving ICBT plus CBM will show superior treatment outcomes.

    Methods/design

    Participants with SAD (N = 128), will be recruited from the general population. A composite score combining the scores obtained from three social anxiety questionnaires will serve as the primary outcome measure. Secondary measures include self-reported depression and quality of life. All treatments and assessments will be conducted via the Internet and measurement points will be baseline, Week 2, post-treatment, and 4 months post-treatment.

    Discussion

    There is no direct evidence of the effects of combining CBM and ICBT in SAD. Adding attention-training sessions to ICBT protocols could increase the proportion of participants who improve and recover through Internet-based self-help.

    Trial registration

    ClinicalTrials.gov:NCT01570400

    Download full text (pdf)
    fulltext
  • 35.
    Boettcher, Johanna
    et al.
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Andersson, Gerhard
    Carlbring, Per
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 68Article in journal (Refereed)
    Abstract [en]

    Background: Guided Internet-based cognitive-behavioral therapy (ICBT) has been found to be effective for social anxiety disorder (SAD) by several independent research groups. However, since the extent of clinically significant change demonstrated leaves room for improvement, new treatments should be developed and investigated. A novel treatment, which has generally been found to be effective, is cognitive bias modification (CBM). This study aims to evaluate the combination of CBM and ICBT. It is intended that two groups will be compared; one group randomized to receiving ICBT and CBM towards threat cues and one group receiving ICBT and control training. We hypothesize that the group receiving ICBT plus CBM will show superior treatment outcomes.

    Methods/design: Participants with SAD (N = 128), will be recruited from the general population. A composite score combining the scores obtained from three social anxiety questionnaires will serve as the primary outcome measure. Secondary measures include self-reported depression and quality of life. All treatments and assessments will be conducted via the Internet and measurement points will be baseline, Week 2, post-treatment, and 4 months post-treatment.

    Discussion: There is no direct evidence of the effects of combining CBM and ICBT in SAD. Adding attention-training sessions to ICBT protocols could increase the proportion of participants who improve and recover through Internet-based self-help.

  • 36.
    Brännholm Syrjälä, Maria
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    Bennet, L.
    Department of Clinical Sciences, Lund University, Malmö, Sweden; Center for Primary Health Care Research, Region Skåne and Lund University, Malmö, Sweden; Clinical Research and Trial Center, Lund University Hospital, Lund, Sweden.
    Dempsey, P.C.
    Baker Heart and Diabetes Institute, Melbourne, Australia; MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom; Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, United Kingdom.
    Fhärm, Eva
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    Hellgren, M.
    Skaraborg Institute, Skövde, Sweden.
    Jansson, S.
    School of Medical Sciences, University Health Care Research Center, Örebro University, Örebro, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
    Nilsson, S.
    Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
    Nordendahl, Maria
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    Rolandsson, Olov
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    Rådholm, K.
    Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
    Ugarph-Morawski, A.
    Academic Primary Care Center, Region Stockholm, Stockholm, Sweden; Department of Neurobiology, Care Sciences, and Society, Division of Family Medicine and Primary Care, The Karolinska Institute, Huddinge, Sweden.
    Wändell, P.
    Department of Neurobiology, Care Sciences, and Society, Division of Family Medicine and Primary Care, The Karolinska Institute, Huddinge, Sweden.
    Wennberg, Patrik
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial—the ROSEBUD study2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 607Article in journal (Refereed)
    Abstract [en]

    Background: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM.

    Methods: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides.

    Discussion: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.

    Download full text (pdf)
    fulltext
  • 37.
    Bunker, Aditi
    et al.
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Compoaré, Guillaume
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Sewe, Maquins Odhiambo
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Section of Sustainable Health. Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Laurent, Jose Guillermo Cedeno
    Environmental Health and Occupational Health Sciences Institute, School of Public Health, Rutgers University, Rutgers, United States.
    Zabré, Pascal
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Boudo, Valentin
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Ouédraogo, Windpanga Aristide
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Ouermi, Lucienne
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Jackson, Susan T.
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Arisco, Nicholas
    Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, United States.
    Vijayakumar, Govind
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Yildirim, Ferhat Baran
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Barteit, Sandra
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
    Maggioni, Martina Anna
    Charité - Universitätsmedizin Berlin, Institute of Physiology, Center for Space Medicine and Extreme Environments, Berlin, Germany; Department of Biomedical Sciences for Health, Università Degli Studi Di Milano, Milan, Italy.
    Woodward, Alistair
    Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
    Buonocore, Jonathan J.
    Department of Environmental Health, Boston University School of Public Health, Boston, United States.
    Regassa, Mekdim Dereje
    Leibniz Institute of Vegetable and Ornamental Crops (IGZ), Großbeeren, Germany.
    Brück, Tilman
    Leibniz Institute of Vegetable and Ornamental Crops (IGZ), Großbeeren, Germany; Thaer-Institute, Humboldt-University of Berlin, Berlin, Germany; International Security and Development Center (ISDC), Berlin, Germany.
    Sié, Ali
    Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.
    Bärnighausen, Till
    Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, United States; Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.
    The effects of cool roofs on health, environmental, and economic outcomes in rural Africa: study protocol for a community-based cluster randomized controlled trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 59Article in journal (Refereed)
    Abstract [en]

    Background: High ambient air temperatures in Africa pose significant health and behavioral challenges in populations with limited access to cooling adaptations. The built environment can exacerbate heat exposure, making passive home cooling adaptations a potential method for protecting occupants against indoor heat exposure.

    Methods: We are conducting a 2-year community-based stratified cluster randomized controlled trial (cRCT) implementing sunlight-reflecting roof coatings, known as “cool roofs,” as a climate change adaptation intervention for passive indoor home cooling. Our primary research objective is to investigate the effects of cool roofs on health, indoor climate, economic, and behavioral outcomes in rural Burkina Faso. This cRCT is nested in the Nouna Health and Demographic Surveillance System (HDSS), a population-based dynamic cohort study of all people living in a geographically contiguous area covering 59 villages, 14305 households and 28610 individuals. We recruited 1200 participants, one woman and one man, each in 600 households in 25 villages in the Nouna HDSS. We stratified our sample by (i) village and (ii) two prevalent roof types in this area of Burkina Faso: mud brick and tin. We randomized the same number of people (12) and homes (6) in each stratum 1:1 to receiving vs. not receiving the cool roof. We are collecting outcome data on one primary endpoint - heart rate, (a measure of heat stress) and 22 secondary outcomes encompassing indoor climate parameters, blood pressure, body temperature, heat-related outcomes, blood glucose, sleep, cognition, mental health, health facility utilization, economic and productivity outcomes, mosquito count, life satisfaction, gender-based violence, and food consumption. We followed all participants for 2 years, conducting monthly home visits to collect objective and subjective outcomes. Approximately 12% of participants (n = 152) used smartwatches to continuously measure endpoints including heart rate, sleep and activity.

    Discussion: Our study demonstrates the potential of large-scale cRCTs to evaluate novel climate change adaptation interventions and provide evidence supporting investments in heat resilience in sub-Saharan Africa. By conducting this research, we will contribute to better policies and interventions to help climate-vulnerable populations ward off the detrimental effects of extreme indoor heat on health.

    Trial registration: German Clinical Trials Register (DRKS) DRKS00023207. Registered on April 19, 2021.

    Download full text (pdf)
    fulltext
  • 38.
    Carlbring, Per
    et al.
    Department of Psychology, Stockholm University, Stockholm, Sweden.
    Lindner, Philip
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden and Department of Psychology, Umeå University, Umeå, Sweden .
    Martell, Christopher
    Martell Behavioral Activation Research Consulting and Department of Psychology, University of Wisconsin, Milwaukee, WI, USA.
    Hassmén, Peter
    Department of Psychology, Umeå University, Umeå, Sweden.
    Forsberg, Lars
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
    Ström, Lars
    Department of Psychology, Umeå University, Umeå, Sweden.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 35Article in journal (Refereed)
    Abstract [en]

    Background

    Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

    Methods/Design

    This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

    Discussion

    The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.

    Trial registration

    ClinicalTrials.gov: NCT01619930

    Download full text (pdf)
    fulltext
  • 39. Carlbring, Per
    et al.
    Lindner, Philip
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Martell, Christopher
    Hassmén, Peter
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Forsberg, Lars
    Ström, Lars
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Andersson, Gerhard
    The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, p. 35-Article in journal (Refereed)
    Abstract [en]

    Background: Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components. Methods/Design: This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements done via telephone and the Internet -will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period. Discussion: The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.

    Download full text (pdf)
    fulltext
  • 40.
    Carlbring, Per
    et al.
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Lindner, Philip
    Martell, Christopher
    Hassmén, Peter
    Forsberg, Lars
    Ström, Lars
    Andersson, Gerhard
    The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, p. 35-Article in journal (Refereed)
    Abstract [en]

    Background: Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

    Methods/Design: This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

    Discussion: The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.

  • 41.
    Casey, Máire-Bríd
    et al.
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Smart, Keith
    St Vincents Univ Hosp, Physiotherapy Dept, Elm Pk, Dublin, Ireland.
    Segurado, Ricardo
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Hearty, Conor
    Mater Misericordiae Univ Hosp, Dept Pain Med, Eccles St, Dublin, Ireland.
    Gopal, Hari
    Mater Misericordiae Univ Hosp, Dept Pain Med, Eccles St, Dublin, Ireland.
    Lowry, Damien
    Mater Misericordiae Univ Hosp, Psychol Dept, Eccles St, Dublin, Ireland.
    Flanagan, Dearbhail
    Mater Misericordiae Univ Hosp, Physiotherapy Dept, Eccles St, Dublin, Ireland.
    McCracken, Lance
    Kings Coll London, Inst Psychiat Psychol & Neurosci, Psychol Dept, London, England.
    Doody, Catherine
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial2018In: Trials, E-ISSN 1745-6215, Vol. 19, article id 194Article in journal (Refereed)
    Abstract [en]

    Background: Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise.

    Methods/design: This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit ZipTM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a purposeful sample of participants to explore patient experiences of both treatments.

    Discussion: To our knowledge, this will be the first RCT to examine whether combining exercise with ACT produces greater benefit for patients with chronic pain, compared to a standalone supervised exercise programme.

    Trial registration: www.ClinicalTrials.gov, ID: NCT03050528. Registered on 13 February 2017.

    Download full text (pdf)
    fulltext
  • 42.
    Chen, C.
    et al.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Ahlqvist, V. H.
    Karolinska Inst, Sweden.
    Henriksson, Pontus
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Hidalgo Migueles, Jairo Hidalgo
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. Univ Granada, Spain.
    Christiansen, F.
    Karolinska Inst, Sweden.
    Galanti, M. R.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Berglind, D.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Increasing Childrens physical Activity by Policy (CAP) in preschools within the Stockholm region: study protocol for a pragmatic cluster-randomized controlled trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 577Article in journal (Refereed)
    Abstract [en]

    Background: Systematic reviews suggest that preschool environmental/organizational changes may be effective in increasing physical activity (PA) levels of preschool children, but evidence is scarce regarding feasible, effective, and equitable interventions that can be scaled up. Specifically, it is essential to understand whether introducing a multicomponent organizational change in terms of policy in the preschool context may be beneficial for childrens PA levels and concomitant health outcomes. To bridge this knowledge gap, our main aim is to examine the feasibility and effectiveness of a policy package in increasing PA levels in preschool children, using a large-scale pragmatic cluster-randomized controlled trial. Methods: This proposed study is a pragmatic cluster-randomized controlled trial with two conditions (intervention and control with a 1:1 ratio) with preschools as clusters and the unit of randomization. We aim to recruit approximately 4000 3-5-year-old children from 90 preschools and retain more than 2800 children from 85 preschools to provide adequate statistical power for the analyses. The intervention to implement is a co-created, multicomponent policy package running for 6 months in preschools randomized to intervention. Change in accelerometer measured PA levels in children between intervention and control from pre- and post-intervention will be the primary outcome of the study, while secondary outcomes include health outcomes such as musculoskeletal fitness, psychosocial functioning, and absence due to illness in children among others. Implementation will be studied carefully using both quantitative (dose, fidelity) and qualitative (interview) methodologies. The change in primary and secondary outcomes, from pre- to post-intervention, will be analyzed with linear mixed-effect models (to allow both fixed and random effects) nested on a preschool level. Discussion: This is a large-scale co-creation project involving the City of Stockholm, childcare stakeholders, preschool staff, and the research group with the potential to influence more than 30,000 preschool children within the Stockholm area. The study will add reliable evidence for the implementation of PA policies at the organizational level of preschools and clarify its potential effect on objectively measured PA and health markers in children.

    Download full text (pdf)
    fulltext
  • 43.
    Crippa, Alessio
    et al.
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    De Laere, Bram
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden; Univ Ghent, Dept Human Struct & Repair, Ghent, Belgium.
    Discacciati, Andrea
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    Larsson, Berit
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    Connor, Jason T.
    Univ Cent Florida, Coll Med, Orlando, FL 32816 USA; Confluence Stat LLC, Orlando, FL, USA.
    Gabriel, Erin E.
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    Thellenberg, Camilla
    Umeå Univ, Dept Radiat Sci & Oncol, Umeå, Sweden.
    Jänes, Elin
    Länssjukhuset Sundsvall Härnösand, Sundsvall, Sweden.
    Enblad, Gunilla
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Ullen, Anders
    Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.
    Hjälm-Eriksson, Marie
    Capio St Görans Hosp, Stockholm, Sweden.
    Oldenburg, Jan
    Univ Oslo, Div Med, Oslo, Norway.
    Ost, Piet
    Univ Ghent, Dept Radiotherapy & Expt Canc Res, Ghent, Belgium.
    Lindberg, Johan
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    Eklund, Martin
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    Grönberg, Henrik
    Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden.
    The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 579Article in journal (Refereed)
    Abstract [en]

    Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis.

    Methods: The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC.

    Discussion: Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study.

    Conclusions: The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care.

    Download full text (pdf)
    FULLTEXT01
  • 44. Crippa, Alessio
    et al.
    De Laere, Bram
    Discacciati, Andrea
    Larsson, Berit
    Connor, Jason T.
    Gabriel, Erin E.
    Thellenberg-Karlsson, Camilla
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Jänes, Elin
    Enblad, Gunilla
    Ullen, Anders
    Hjälm-Eriksson, Marie
    Oldenburg, Jan
    Ost, Piet
    Lindberg, Johan
    Eklund, Martin
    Grönberg, Henrik
    The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 579Article in journal (Refereed)
    Abstract [en]

    Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis.

    Methods: The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC.

    Discussion: Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study.

    Conclusions: The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care.

    Download full text (pdf)
    fulltext
  • 45.
    de Graaf, Nine
    et al.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Emmen, Anouk M. L. H.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Ramera, Marco
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy.
    Björnsson, Bergthor
    Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping. Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology.
    Boggi, Ugo
    Department of Surgery, Universitá Di Pisa, Pisa, Italy.
    Bruna, Caro L.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Busch, Olivier R.
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Daams, Freek
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Ferrari, Giovanni
    Department of Surgery, Niguarda Ca’Granda Hospital, Milan, Italy.
    Festen, Sebastiaan
    Cancer Center Amsterdam, Amsterdam, Netherlands.
    van Hilst, Jony
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, NetherlandsDepartment of Surgery, OLVG, Amsterdam, Netherlands.
    D’Hondt, Mathieu
    Department of Surgery, AZ Groeninge, Kortrijk, Belgium.
    Ielpo, Benedetto
    Department of Surgery, Hospital del Mar, Barcelona, Spain.
    Keck, Tobias
    Department of Surgery, UKSH Campus Lübeck, Lübeck, Germany.
    Khatkov, Igor E.
    Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation.
    Koerkamp, Bas Groot
    Department of Surgery, Erasmus MC, Rotterdam, Netherlands.
    Lips, Daan J.
    Department of Surgery, Medisch Spectrum Twente, Enschede, Netherlands.
    Luyer, Misha D. P.
    Department of Surgery, Catharina Ziekenhuis, Eindhoven, Netherlands.
    Mieog, J. Sven D.
    Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.
    Morelli, Luca
    General Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
    Molenaar, I. Quintus
    Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands .
    van Santvoort, Hjalmar C.
    Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands .
    Sprangers, Mirjam A. G.
    Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
    Ferrari, Clarissa
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
    Berkhof, Johannes
    Department of Epidemiology and Data Science, Amsterdam UMC, VU University, Amsterdam, Netherlands.
    Maisonneuve, Patrick
    Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy.
    Abu Hilal, Mohammad
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
    Besselink, Marc G.
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 665Article in journal (Refereed)
    Abstract [en]

    Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023. © 2023, BioMed Central Ltd., part of Springer Nature.

  • 46.
    Dierig, A.
    et al.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany..
    Hoelscher, M.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany..
    Schultz, S.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany..
    Hoffmann, L.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany..
    Jarchow-MacDonald, A.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany.;NHS Tayside, Ninewells Hosp & Med Sch, Dundee, Scotland..
    Svensson, Elin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy. Radboud Univ Nijmegen, Dept Pharm, Med Ctr, Nijmegen, Netherlands..
    Te Brake, L.
    Radboud Univ Nijmegen, Dept Pharm, Med Ctr, Nijmegen, Netherlands..
    Aarnoutse, R.
    Radboud Univ Nijmegen, Dept Pharm, Med Ctr, Nijmegen, Netherlands..
    Boeree, M.
    Radboud Univ Nijmegen, Dept Pharm, Med Ctr, Nijmegen, Netherlands..
    McHugh, T. D.
    UCL, UCL Ctr Clin Microbiol, Div Infect & Immun, London, England..
    Wildner, L. M.
    UCL, UCL Ctr Clin Microbiol, Div Infect & Immun, London, England..
    Gong, X.
    Univ Calif San Francisco, Dept Med, Div Pulm & Crit Care Med, San Francisco, CA USA..
    Phillips, P. P. J.
    Univ Calif San Francisco, Dept Med, Div Pulm & Crit Care Med, San Francisco, CA USA..
    Minja, L. T.
    Mbeya Med Res Ctr NIMR MMRC, Natl Inst Med Res, Mbeya, Tanzania..
    Ntinginya, N.
    Mbeya Med Res Ctr NIMR MMRC, Natl Inst Med Res, Mbeya, Tanzania..
    Mpagama, S.
    Kilimanjaro Clin Res Inst, Kilimanjaro, Tanzania..
    Liyoyo, A.
    Kilimanjaro Clin Res Inst, Kilimanjaro, Tanzania..
    Wallis, R. S.
    Aurum Inst, Tembisa, South Africa..
    Sebe, M.
    Aurum Inst, Tembisa, South Africa..
    Mhimbira, F. A.
    Ifakara Hlth Inst, Dar Es Salaam, Tanzania..
    Mbeya, B.
    Ifakara Hlth Inst, Dar Es Salaam, Tanzania..
    Rassool, M.
    Univ Witwatersrand, Helen Joseph Hosp, Fac Hlth Sci, Sch Clin Med,Dept Internal Med,Clin HIV Res Unit, Johannesburg, South Africa..
    Geiter, L.
    LegoChem Biosci, Daejeon, South Korea..
    Cho, Y. L.
    LegoChem Biosci, Daejeon, South Korea..
    Heinrich, N.
    LMU Univ Hosp Munich, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res DZ, Munich Partner Site, Munich, Germany..
    A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 382Article in journal (Refereed)
    Abstract [en]

    Background: Linezolid is an effective, but toxic anti-tuberculosis drug that is currently recommended for the treatment of drug-resistant tuberculosis. Improved oxazolidinones should have a better safety profile, while preserving efficacy. Delpazolid is a novel oxazolidinone developed by LegoChem Biosciences Inc. that has been evaluated up to phase 2a clinical trials. Since oxazolidinone toxicity can occur late in treatment, LegoChem Biosciences Inc. and the PanACEA Consortium designed DECODE to be an innovative dose-ranging study with long-term follow-up for determining the exposure-response and exposure-toxicity relationship of delpazolid to support dose selection for later studies. Delpazolid is administered in combination with bedaquiline, delamanid and moxifloxacin.

    Methods: Seventy-five participants with drug-sensitive, pulmonary tuberculosis will receive bedaquiline, delamanid and moxifloxacin, and will be randomized to delpazolid dosages of 0 mg, 400 mg, 800 mg, 1200 mg once daily, or 800 mg twice daily, for 16 weeks. The primary efficacy endpoint will be the rate of decline of bacterial load on treatment, measured by MGIT liquid culture time to detection from weekly sputum cultures. The primary safety endpoint will be the proportion of oxazolidinone class toxicities; neuropathy, myelosuppression, or tyramine pressor response. Participants who convert to negative liquid media culture by week 8 will stop treatment after the end of their 16-week course and will be observed for relapse until week 52. Participants who do not convert to negative culture will receive continuation phase treatment with rifampicin and isoniazid to complete a six-month treatment course.

    Discussion: DECODE is an innovative dose-finding trial, designed to support exposure-response modelling for safe and effective dose selection. The trial design allows assessment of occurrence of late toxicities as observed with linezolid, which is necessary in clinical evaluation of novel oxazolidinones. The primary efficacy endpoint is the change in bacterial load, an endpoint conventionally used in shorter dose-finding trials. Long-term follow-up after shortened treatment is possible through a safety rule excluding slow-and non-responders from potentially poorly performing dosages.

    Download full text (pdf)
    FULLTEXT01
  • 47.
    Donker, Tara
    et al.
    Vrije University Amsterdam.
    van Straten, Annemieke
    Vrije University Amsterdam.
    Riper, Heleen
    Vrije University Amsterdam.
    Marks, Isaac
    Kings College London.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Clinical and Social Psychology. Linköping University, Faculty of Arts and Sciences.
    Cuijpers, Pim
    Vrije University Amsterdam.
    Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial2009In: Trials, E-ISSN 1745-6215, Vol. 10, no 59Article in journal (Refereed)
    Abstract [en]

    Background: Internet-based self-help is an effective preventive intervention for highly prevalent disorders, such as depression and anxiety. It is not clear, however, whether it is necessary to offer these interventions with professional support or if they work without any guidance. In case support is necessary, it is not clear which level of support is needed. This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support. Methods: In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email); (3) the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by email); (4) weekly scheduled contacts initiated by a coach, but no web-based intervention; (5) information only (through the internet). The interventions will consist of five weekly lessons. Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are drop-out from the intervention, quality of life, and economic costs. Other secondary outcome measures that may predict outcome are also studied, e. g. client satisfaction and problem-solving skills. Measures are taken at baseline (pre-test), directly after the intervention (post-test, five weeks after baseline), 3 months later, and 12 months later. Analysis will be conducted on the intention-to-treat sample. Discussion: This study aims to provide more insight into the clinical effectiveness, differences in drop-out rate and costs between interventions with and without support, and in particular different levels of support. This is important to know in relation to the dissemination of internet-based self-help interventions.

    Download full text (pdf)
    FULLTEXT01
  • 48. Durbeej, Natalie
    et al.
    McDiarmid, Serena
    Sarkadi, Anna
    Feldman, Inna
    Punamäki, Raija-Leena
    Kankaanpää, Reeta
    Andersen, Arnfinn
    Hilden, Per Kristian
    Verelst, An
    Derluyn, Ilse
    Osman, Fatumo
    Dalarna University, School of Health and Welfare, Caring Science/Nursing. Uppsala University.
    Correction to: Evaluation of a school-based intervention to promote mental health of refugee youth in Sweden (The RefugeesWellSchool Trial)2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 861Article in journal (Refereed)
    Download full text (pdf)
    fulltext
  • 49.
    Durbeej, Natalie
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    McDiarmid, Serena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    Sarkadi, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    Feldman, Inna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP.
    Punamäki, Raija-Leena
    Kankaanpää, Reeta
    Andersen, Arnfinn
    Hilden, Per Kristian
    Verelst, An
    Derluyn, Ilse
    Osman, Fatumo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social medicine/CHAP. School of Education, Health and Social Studies, Dalarna University, 791 88, Falun, Sweden.
    Evaluation of a school-based intervention to promote mental health of refugee youth in Sweden (The RefugeesWellSchool Trial): study protocol for a cluster randomized controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 98Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Sweden is home to a large and growing population of refugee youths who may be at risk of mental health problems such as post-traumatic stress disorder (PTSD). Thus, there is a need for interventions that address mental health problems in these populations. Schools have been identified as an ideal setting for delivering such interventions as they offer a non-stigmatizing space and are often central to young refugees' social networks. The RefugeesWellSchool trial in Sweden will investigate an intervention comprising two programmes: Teaching Recovery Techniques (TRT) and In-service Teacher Training (INSETT), delivered in a school setting, among refugee youth. TRT is a group-based programme for children and adolescents, informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). INSETT is a multi-module course for teachers providing information on trauma and the refugee experience to build teachers' cultural competence and capacity for supporting refugee youths in schools.

    METHODS: This trial employs a cluster randomized-control design with two arms: (1) the intervention arm in which the TRT and INSETT programmes are offered (n = 350), (2) the wait-list control arm (n = 350) in which services are provided as usual until the TRT and INSETT programmes are offered approximately six months later. Data will be collected prior to the intervention, immediately following the intervention, and at three months post-intervention. Outcomes for the trial arms will be compared using linear mixed models or ANCOVA repeated measures as well as the Reliable Change Index (RCI).

    DISCUSSION: This study will provide knowledge about the effectiveness of an intervention comprising two programmes: a group-based programme for youth reporting symptoms of PTSD and a training course for teachers, in order to build their competence and ability to support refugee youths in schools.

    TRIAL REGISTRATION: ISRCTN, ISRCTN48178969 , Retrospectively registered 20/12/2019.

    Download full text (pdf)
    fulltext
  • 50. Durbeej, Natalie
    et al.
    McDiarmid, Serena
    Sarkadi, Anna
    Feldman, Inna
    Punamäki, Raija-Leena
    Kankaanpää, Reeta
    Andersen, Arnfinn
    Hilden, Per Kristian
    Verelst, An
    Osman, Fatumo
    Dalarna University, School of Health and Welfare, Caring Science/Nursing. Uppsala University.
    Evaluation of a school-based intervention to promote mental health of refugee youth in Sweden (The RefugeesWellSchool Trial): study protocol for a cluster randomized controlled trial.2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 98Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Sweden is home to a large and growing population of refugee youths who may be at risk of mental health problems such as post-traumatic stress disorder (PTSD). Thus, there is a need for interventions that address mental health problems in these populations. Schools have been identified as an ideal setting for delivering such interventions as they offer a non-stigmatizing space and are often central to young refugees' social networks. The RefugeesWellSchool trial in Sweden will investigate an intervention comprising two programmes: Teaching Recovery Techniques (TRT) and In-service Teacher Training (INSETT), delivered in a school setting, among refugee youth. TRT is a group-based programme for children and adolescents, informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). INSETT is a multi-module course for teachers providing information on trauma and the refugee experience to build teachers' cultural competence and capacity for supporting refugee youths in schools.

    METHODS: This trial employs a cluster randomized-control design with two arms: (1) the intervention arm in which the TRT and INSETT programmes are offered (n = 350), (2) the wait-list control arm (n = 350) in which services are provided as usual until the TRT and INSETT programmes are offered approximately six months later. Data will be collected prior to the intervention, immediately following the intervention, and at three months post-intervention. Outcomes for the trial arms will be compared using linear mixed models or ANCOVA repeated measures as well as the Reliable Change Index (RCI).

    DISCUSSION: This study will provide knowledge about the effectiveness of an intervention comprising two programmes: a group-based programme for youth reporting symptoms of PTSD and a training course for teachers, in order to build their competence and ability to support refugee youths in schools.

    TRIAL REGISTRATION: ISRCTN, ISRCTN48178969 , Retrospectively registered 20/12/2019.

    Download full text (pdf)
    fulltext
12345 1 - 50 of 217
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf