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Negative effects of Internet-based cognitive behavior therapy: Monitoring and reporting deterioration and adverse and unwanted events
Stockholms universitet, Samhällsvetenskapliga fakulteten, Psykologiska institutionen, Klinisk psykologi. (Per Carlbring)ORCID-id: 0000-0002-1019-0245
2016 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Abstract [en]

Internet-based cognitive behavior therapy (ICBT) has the potential of providing many patients with an effective form of psychological treatment. However, despite helping to improve mental health and well-being, far from everyone seem to benefit. In some cases, negative effects may also emerge. The overall aim of the present thesis was to establish the occurrence and characteristics of such incidents in ICBT using a combination of quantitative and qualitative methods. Study I determined deterioration, non-response, and adverse and unwanted events in a sample of 133 patients undergoing ICBT for social anxiety disorder. The results indicated that up to 6.8% fared worse during the treatment period, depending on the self-report measure and time point, as determined using the Reliable Change Index (RCI), while the non-response rate was between 29.3 to 86.5% at post treatment assessment, and 12.9% experienced other negative effects. Study II investigated the responses to open-ended questions on adverse and unwanted events among 556 patients in four separate clinical trials of ICBT; social anxiety disorder, panic disorder, major depressive disorder, and procrastination. In total, 9.3% reported negative effects, with a qualitative content analysis revealing two categories and four subcategories; patient-related, i.e., gaining insight and experiencing new symptoms, and treatment-related, i.e., difficulties applying the treatment interventions and problems related to the treatment format. Study III explored the number of patients achieving reliable deterioration, as determined using the RCI on the individual raw scores of 2866 patients from 29 clinical trials of ICBT. The results showed that the deterioration rate was higher among patients in a control condition, 17.4%, in comparison to treatment, 5.8%. Predictors were related to decreased odds of deterioration for patients receiving treatment; clinical severity at pre treatment assessment, being in a relationship, having a university degree, and being older. As for the control condition, only clinical severity at pre treatment assessment was associated with decreased odds of deterioration. Study IV examined a newly developed self-report measure for monitoring and reporting adverse and unwanted events, the Negative Effects Questionnaire. The results suggested a six-factor solution with 32 items; symptoms, quality, dependency, stigma, hopelessness, and failure. One-third of the patients reported experiencing unpleasant memories, stress, and anxiety, with novel symptoms and a lack of quality in the treatment and therapeutic relationship having the greatest negative impact. The general finding of the present thesis is that negative effects do occur in ICBT and that they are characterized by deterioration, non-response, and adverse and unwanted events, similar to psychological treatments delivered face-to-face. Researchers and clinicians in ICBT are recommended to monitor and report negative effects to prevent a negative treatment trend and further the understanding of what might contribute to their incidents. Future research should investigate the relationship between negative effects and treatment outcome, especially at follow-up, to examine if they are transient or enduring. Also, interviews could be conducted with those achieving reliable deterioration to explore if and how it is experienced by the patients and to see if it is attributed to the treatment interventions or other circumstances.

Abstract [sv]

Internetbaserad kognitiv beteendeterapi (IKBT) har goda förutsättningar att kunna bli en form av psykologisk behandling som på ett effektivt sätt hjälper patienter med att hantera sin psykiska ohälsa och förbättra sitt välmående. Trots detta är det dock långtifrån alla som tycks bli bättre. För en del kan det till och med resultera i negativa effekter. Det övergripande syftet med denna avhandling har således varit att undersöka förekomsten av sådana fall och hur dessa uttrycks, såväl med kvantitativa som kvalitativa metoder. Studie I fastställde andelen försämrade, oförändrade samt andra ogynnsamma eller oönskade händelser bland 133 personer som behandlades med IKBT för social ångest. Resultatet visade att uppemot 6,8 % försämrades under sin behandlingsperiod beroende på vilket självskattningsformulär respektive tidpunkt som studerades, beräknat enligt metoden Reliable Change Index (RCI). Likaså var 29,3 % till 86,5 % oförändrade vid eftermätningen samt att 12,9 % rapporterade andra former av negativa effekter. Studie II undersökte svaren på öppna frågor som gällde ogynnsamma eller oönskade händelser bland 556 patienter i fyra olika kliniska studier med IKBT; social ångest, paniksyndrom, egentlig depressionsepisod och prokrastinering. Totalt sett rapporterade 9,3 % att de hade erfarit negativa effekter, vilka analyserades med hjälp av kvalitativ innehållsanalys. Två övergripande kategorier och fyra subkategorier framkom; patientrelaterade, som ökad insikt respektive nya symptom, samt behandlingsrelaterade, som svårigheter att implementera behandlingsinterventionerna respektive problem med behandlingsformatet. Studie III utrönte andelen patienter som försämrades i enlighet med RCI, baserat på insamlad rådata från 2866 personer i 29 olika kliniska studier med IKBT. Resultatet visade att försämring var mer förekommande hos de som var i en kontrollgrupp, 17,4 %, jämfört med de som fick behandling, 5,8 %. Bland de som genomgick behandling existerade det även ett par prediktorer som innebar lägre odds för försämring; större svårigheter vid förmätningen, att befinna sig i en relation, att ha en universitetsutbildning respektive att vara äldre. För de som var i en kontrollgrupp var enbart större svårigheter vid förmätningen relaterat till lägre odds för försämring. Studie IV testade ett nykonstruerat självskattningsformulär; Negative Effects Questionnaire. Resultatet visade på en faktorlösning med sex faktorer och 32 påståenden; symptom, kvalitet, beroende, stigma, hopplöshet respektive misslyckande. En tredjedel av personerna svarade att de hade upplevt obehagliga minnen, stress och ångest, samtidigt som nya symptom och bristande kvalitet i både behandlingen respektive den terapeutiska relationen hade haft störst negativ inverkan på dem. Den generella slutsatsen av denna avhandling är således att negativa effekter förekommer i IKBT och att de kännetecknas av försämring, ett oförändrat tillstånd samt andra ogynnsamma eller oönskade händelser, något som liknar tidigare forskning av psykologisk behandling som bedrivs ansikte-mot-ansikte. Forskare och behandlare i IKBT rekommenderas att övervaka och rapportera negativa effekter i syfte att förhindra en negativ utveckling i behandlingen samt för att öka kunskapen om vad som kan bidra till deras förekomst. Framtida forskning bör undersöka relationen mellan negativa effekter och behandlingsutfall utifrån längre tidsperspektiv för att se om dess påverkan är övergående eller ihållande. Vidare kan till exempel intervjuer utföras med de patienter som har försämrats för att ta reda på om och hur det uppfattas samt huruvida det har förorsakats av behandlingen eller andra omständigheter.

Ort, förlag, år, upplaga, sidor
Stockholm: Department of Psychology, Stockholm University , 2016. , 89 s.
Nyckelord [en]
Negative effects, Internet-based cognitive behavior therapy, deterioration, non-response, adverse and unwanted events, qualitative content analysis, individual patient data meta-analysis, exploratory factor analysis, Negative Effects Questionnaire
Nyckelord [sv]
Negativa effekter, Internetbaserad kognitiv beteendeterapi, försämring, oförändrat tillstånd, ogynnsamma eller oönskade händelser, kvalitativ innehållsanalys, individuell patient meta-analys, explorativ faktoranalys, Negative Effects Questionnaire
Nationell ämneskategori
Samhällsvetenskap Psykologi Tillämpad psykologi
Forskningsämne
psykologi
Identifikatorer
URN: urn:nbn:se:su:diva-135382ISBN: 978-91-7649-597-1 (tryckt)ISBN: 978-91-7649-598-8 (tryckt)OAI: oai:DiVA.org:su-135382DiVA: diva2:1045149
Disputation
2017-02-03, David Magnussonsalen (U31), Frescati Hagväg 8, Stockholm, 10:00 (Engelska)
Opponent
Handledare
Forskningsfinansiär
Forte, Forskningsrådet för hälsa, arbetsliv och välfärd, 2013-1107
Anmärkning

At the time of the doctoral defense, the following paper was unpublished and had a status as follows: Paper 4: In press.

Tillgänglig från: 2017-01-11 Skapad: 2016-11-08 Senast uppdaterad: 2017-02-09Bibliografiskt granskad
Delarbeten
1. Side effects in Internet-based interventions for Social Anxiety Disorder
Öppna denna publikation i ny flik eller fönster >>Side effects in Internet-based interventions for Social Anxiety Disorder
2014 (Engelska)Ingår i: Internet Interventions, ISSN 2214-7829, Vol. 1, nr 1, 3-11 s.Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Internet-based interventions are effective in the treatment of various mental disorders and have already been integrated in routine health care in some countries. Empirical data on potential negative effects of these interventions is lacking. This study investigated side effects in an Internet-based treatment for Social Anxiety Disorder (SAD).

A total of 133 individuals diagnosed with SAD took part in an 11-week guided treatment. Side effects were assessed as open formatted questions after week 2 and at post-treatment after week 11. Answers were independently rated by two coders. In addition, rates of deterioration and non-response were calculated for primary social anxiety and secondary outcome measures (depression and quality of life).

In total, 19 participants (14%) described unwanted negative events that they related to treatment. The emergence of new symptoms was the most commonly experienced side effect, followed by the deterioration of social anxiety symptoms and negative well-being. The large majority of the described side effects had a temporary but no enduring negative effect on participants' well-being. At post-treatment, none of the participants reported deterioration on social anxiety measures and 0–7% deteriorated on secondary outcome measures. Non-response was frequent with 32–50% for social anxiety measures and 57–90% for secondary outcomes at post-assessment.

Results suggest that a small proportion of participants in Internet-based interventions experiences negative effects during treatment. Information about potential side effects should be integrated in patient education in the practice of Internet-based treatments.

Nyckelord
adverse events, negative effects, online guided self-help, attention training, cognitive-behaviour
Nationell ämneskategori
Psykologi
Forskningsämne
psykologi
Identifikatorer
urn:nbn:se:su:diva-108579 (URN)10.1016/j.invent.2014.02.002 (DOI)
Tillgänglig från: 2014-10-29 Skapad: 2014-10-29 Senast uppdaterad: 2016-12-19Bibliografiskt granskad
2. Negative Effects of Internet Interventions: A Qualitative Content Analysis of Patients' Experiences with Treatments Delivered Online
Öppna denna publikation i ny flik eller fönster >>Negative Effects of Internet Interventions: A Qualitative Content Analysis of Patients' Experiences with Treatments Delivered Online
Visa övriga...
2015 (Engelska)Ingår i: Cognitive Behaviour Therapy, ISSN 1650-6073, E-ISSN 1651-2316, Vol. 44, nr 3, 223-236 s.Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Internet interventions are defined as the delivery of health care-related treatments via an online or a smartphone interface, and have been shown to be a viable alternative to face-to-face treatments. However, not all patients benefit from such treatments, and it is possible that some may experience negative effects. Investigations of face-to-face treatments indicate that deterioration occurs in 5-10% of all patients. The nature and scope of other negative effects of Internet interventions is, however, largely unknown. Hence, the current study explored patients' reported negative experiences while undergoing treatments delivered via the Internet. Data from four large clinical trials (total N=558) revealed that 9.3% of patients reported some type of negative effects. Qualitative content analysis was used to explore the patients' responses to open-ended questions regarding their negative experiences. Results yielded two broad categories and four subcategories of negative effects: patient-related negative effects (insight and symptom) and treatment-related negative effects (implementation and format). Results emphasize the importance of always considering negative effects in Internet-based interventions, and point to several ways of preventing such experiences, including regular assessment of negative events, increasing the flexibility of treatment schedules and therapist contact, as well as prolonging the treatment duration.

Nyckelord
psychiatric disorders, negative experiences, qualitative content analysis, negative effects, Internet interventions
Nationell ämneskategori
Psykologi
Forskningsämne
psykologi
Identifikatorer
urn:nbn:se:su:diva-115400 (URN)10.1080/16506073.2015.1008033 (DOI)000350283600004 ()25705924 (PubMedID)
Anmärkning

AuthorCount:5;

Tillgänglig från: 2015-03-23 Skapad: 2015-03-23 Senast uppdaterad: 2016-12-19Bibliografiskt granskad
3. For Better or Worse: An Individual Patient Data Meta-Analysis of Deterioration Among Participants Receiving Internet-Based Cognitive Behavior Therapy
Öppna denna publikation i ny flik eller fönster >>For Better or Worse: An Individual Patient Data Meta-Analysis of Deterioration Among Participants Receiving Internet-Based Cognitive Behavior Therapy
Visa övriga...
2017 (Engelska)Ingår i: Journal of Consulting and Clinical Psychology, ISSN 0022-006X, E-ISSN 1939-2117, Vol. 85, nr 2, 160-177 s.Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Objective: Psychological treatments can relieve mental distress and improve well-being, and the dissemination of evidence-based methods can help patients gain access to the right type of aid. Meanwhile, Internet-based cognitive–behavioral therapy (ICBT) has shown promising results for many psychiatric disorders. However, research on the potential for negative effects of psychological treatments has been lacking. Method: An individual patient data meta-analysis of 29 clinical trials of ICBT (N = 2,866) was performed using the Reliable Change Index for each primary outcome measures to distinguish deterioration rates among patients in treatment and control conditions. Statistical analyses of predictors were conducted using generalized linear mixed models. Missing data was handled by multiple imputation. Results: Deterioration rates were 122 (5.8%) in treatment and 130 (17.4%) in control conditions. Relative to receiving treatment, patients in a control condition had higher odds of deteriorating, odds ratios (ORs) = 3.10, 95% confidence interval (CI) [2.21, 4.34]. Clinical severity at pretreatment was related to lower odds, OR = 0.62, 95% CI [0.50, 0.77], and OR = 0.51, 95% CI [0.51, 0.80], for treatment and control conditions. In terms of sociodemographic variables, being in a relationship, OR = 0.58, 95% CI [0.35, 0.95], having at least a university degree, OR = 0.54, 95% CI [0.33, 0.88], and being older, OR = 0.78, 95% CI, [0.62, 0.98], were also associated with lower odds of deterioration, but only for patients assigned to a treatment condition. Conclusion: Deterioration among patients receiving ICBT or being in a control condition can occur and should be monitored by researchers to reverse and prevent a negative treatment trend.

Nyckelord
Internet-based cognitive behavior therapy, individual patient data meta-analysis, negative effects, deterioration, predictors
Nationell ämneskategori
Psykologi
Forskningsämne
psykologi
Identifikatorer
urn:nbn:se:su:diva-135341 (URN)10.1037/ccp0000158 (DOI)000394993800007 ()
Tillgänglig från: 2016-11-04 Skapad: 2016-11-04 Senast uppdaterad: 2017-05-02Bibliografiskt granskad
4. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events
Öppna denna publikation i ny flik eller fönster >>Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events
Visa övriga...
2016 (Engelska)Ingår i: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 11, nr 6, e0157503Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com.

Nyckelord
negative effects, negative effects questionnaire, exploratory factor analysis
Nationell ämneskategori
Psykologi
Forskningsämne
psykologi
Identifikatorer
urn:nbn:se:su:diva-132301 (URN)10.1371/journal.pone.0157503 (DOI)000378212800031 ()
Anmärkning

The authors of the current study would like to thank Swedish Research Council for Health, Working Life, and Welfare (FORTE 2013-1107) for their generous grant that allowed the development and testing of the instrument for measuring adverse and unwanted events of psychological treatments. The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Tillgänglig från: 2016-08-05 Skapad: 2016-08-05 Senast uppdaterad: 2016-12-19Bibliografiskt granskad

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