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Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
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2015 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 154Article in journal (Refereed) Published
Abstract [en]

Background: Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI. Methods/design: This is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment. Discussion: The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care.

Place, publisher, year, edition, pages
2015. Vol. 16, article id 154
Keywords [en]
Myocardial infarction, CBT, iCBT, Anxiety, Depression, Internet, U-CARE
National Category
Applied Psychology
Identifiers
URN: urn:nbn:se:uu:diva-252686DOI: 10.1186/s13063-015-0689-yISI: 000353018100001PubMedID: 25873137OAI: oai:DiVA.org:uu-252686DiVA, id: diva2:813994
Funder
Swedish Research Council, 2009-1093Available from: 2015-05-25 Created: 2015-05-11 Last updated: 2017-12-13Bibliographically approved
In thesis
1. Psychological distress in coronary heart disease: Risk indicators, treatment and cardiovascular prognosis
Open this publication in new window or tab >>Psychological distress in coronary heart disease: Risk indicators, treatment and cardiovascular prognosis
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The aims of this thesis were to: (1) explore factors associated with emotional distress; (2) investigate psychosocial stress as a risk factor for cardiovascular (CV) morbidity in patients with coronary heart disease (CHD); (3) investigate the impact of group-based stress management on psychological outcomes, and if that mediates risk of CV events; and (4) evaluate an internet-based cognitive behavioral therapy (iCBT) for emotional distress in patients with a recent myocardial infarction (MI).

In Study I, data from the national registry SWEDEHEART on 27,267 MI patients < 75 years was used. Study II was a prospective longitudinal study with 14,577 patients with stable CHD. Psychosocial stress was assessed with a questionnaire and patients were followed-up for clinical events on average 3.7 years. In Study III, a group-based stress management was evaluated in a randomized controlled trial of 362 CHD patients. Psychological outcomes (stress, somatic anxiety, depression and vital exhaustion) were assessed at five time-points over two years. Joint modelling for longitudinal and time-to-event data was used to analyze if reduction in the psychological outcomes mediated the positive effect the treatment had on later CV events. Study IV describes Study V and includes a pilot study investigating the acceptability of the intervention used. In Study V 239 MI patients were recruited to evaluate iCBT versus usual care in a randomized clinical trial.

In summary, in Study I, sociodemographic factors, previous psychiatric diagnosis and readmission for CV events were associated with incident and persistent emotional distress post-MI. In Study II, after multivariable adjustments, depressive symptoms, financial stress and living alone were all independently associated with CV death or the composite of CV death, non-fatal MI or non-fatal stroke. These results emphasize the importance of targeting psychosocial factors in order to optimize secondary prevention. In Study III, somatic anxiety was the only targeted psychological outcome affected positively by stress management, and may have in turn reduced subsequent CV events. Other mediating factors remain to be identified. Study IV indicated the intervention used in Study V was acceptable. Study V concluded that iCBT was not superior to usual care for emotional distress in post-MI patients and treatment adherence was unexpectedly low. Potential reasons for the low adherence require further exploration.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 75
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1412
Keywords
psychological distress, myocardial infarction, coronary heart disease, depression, anxiety, stress, cognitive behavioral therapy, iCBT, stress management, cardiac rehabilitation
National Category
Cardiac and Cardiovascular Systems Psychology
Research subject
Psychology
Identifiers
urn:nbn:se:uu:diva-336234 (URN)978-91-513-0192-1 (ISBN)
Public defence
2018-02-14, Sal IV, Gamla universitetshuset, Biskopsgatan 3, Uppsala, 13:15 (Swedish)
Opponent
Supervisors
Funder
Swedish Research Council, 2009–1093
Available from: 2018-01-24 Created: 2017-12-13 Last updated: 2018-03-07

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