NCT02778074

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Internet cognitive behavioural therapy	A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation.
BEHAVIORAL	Moderated Discussion Forum	Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program.

Timeline

• Start date: 2017-02-06
• Primary completion: 2018-06-30
• Completion: 2019-06-30
• First posted: 2016-05-19
• Last updated: 2019-12-11
• Results posted: 2019-11-27

Locations

1 site across 1 country: Sweden