Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease

University Hospital, Linkoeping

Status: Completed

Conditions: Depression; Cardiovascular Disease

Treatments: Behavioral: Internet cognitive behavioural therapy; Behavioral: Moderated Discussion Forum

Study type: Interventional

Funder types: Other

Identifiers

NCT02778074

2015-02600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups, including a placebo group

Internet Cognitive Behavioural Therapy

Experimental group

Description:

Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.

Treatment:

Behavioral: Internet cognitive behavioural therapy

Moderated discussion forum

Placebo Comparator group

Description:

In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.

Treatment:

Behavioral: Moderated Discussion Forum