Clinical trial NCT02778074: Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
Official title: Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Depression
Keywords: Internet Cognitive Behavioural Therapy
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients. Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.

The overall purpose of this study is to evaluate the effects of the tailored I-CBT program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT program in clinical cardiac care.

The primary aim:

-To evaluate the effects of the tailored I-CBT depression program on depressive symptoms.

Secondary aims:

* To evaluate effects on quality of life´, sleep and anxiety
* To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.
* To gain knowledge about the I-CBT program, as perceived by patients and health care professionals.
* To explore facilitators and barriers to the implementation of the I-CBT program in clinical practice from the perspectives of patients, health care professionals and policymakers.

Detailed description: Power calculation: Effect size=0.5, alpha=0.05 (Z=1.96), Power 0.80 (Z -0.84) = 122 participants. Due to drop-outs or deaths the size of the study population for the RCT study was decided to n=140.

Eligibility criteria: Inclusion Criteria:

* treatment for CVD according to European Society of Cardiology guidelines.
* stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks.
* depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) \> 5 points)

Exclusion Criteria:

* severe CVD (NYHA IV) or another severe chronic life-threatening disease
* severe depression assessed as requiring acute treatment
* not being able to dedicate 3-4 hours to participate in the program

Primary outcomes:
measure: Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Score at 9 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Linkoping University
Study officials:
affiliation: Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden
name: Peter Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johansson P, Lundgren J, Andersson G, Svensson E, Mourad G. Internet-Based Cognitive Behavioral Therapy and its Association With Self-efficacy, Depressive Symptoms, and Physical Activity: Secondary Analysis of a Randomized Controlled Trial in Patients With Cardiovascular Disease. JMIR Cardio. 2022 Jun 3;6(1):e29926. doi: 10.2196/29926.
citation: Mourad G, Lundgren J, Andersson G, Husberg M, Johansson P. Cost-effectiveness of internet-delivered cognitive behavioural therapy in patients with cardiovascular disease and depressive symptoms: secondary analysis of an RCT. BMJ Open. 2022 Apr 11;12(4):e059939. doi: 10.1136/bmjopen-2021-059939.
citation: Westas M, Lundgren J, Andersson G, Mourad G, Johansson P. Effects of Internet-delivered cognitive behavioural therapy adapted for patients with cardiovascular disease and depression: a long-term follow-up of a randomized controlled trial at 6 and 12 months posttreatment. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):559-567. doi: 10.1093/eurjcn/zvab131.
citation: Johansson P, Westas M, Andersson G, Alehagen U, Brostrom A, Jaarsma T, Mourad G, Lundgren J. An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial. JMIR Ment Health. 2019 Oct 3;6(10):e14648. doi: 10.2196/14648.