CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Internet cognitive behavioural therapy +1 morebehavioral
Likely dose
Nine-week internet-guided cognitive behavioral therapy program with psychoeducation, relaxation, problem-solving, and behavioral activation componentsAI-extracted
Key inclusion· 3
  • Diagnosed with cardiovascular disease and receiving treatment according to European Society of Cardiology guidelines
  • Stable CVD with NYHA class I-III and no CVD hospitalization in the past 4 weeks
  • Depressive symptoms with PHQ-9 score greater than 5 points
Key exclusion· 4
  • Severe CVD (NYHA IV)
  • Other severe chronic life-threatening disease
  • Severe depression requiring acute treatment
  • Unable to dedicate 3-4 hours to program participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02778074
NCT02778074N/ACompleted

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

University Hospital, Linkoeping·interventional·Posted May 19, 2016·Updated Dec 11, 2019

In Brief

A clinical study evaluating Internet cognitive behavioural therapy and Moderated Discussion Forum for Cardiovascular Disease and Depression. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartFeb 6, 2017
Primary CompletionJun 30, 2018
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.1 years ago

Interventions

Internet cognitive behavioural therapybehavioral

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.

Moderated Discussion Forumbehavioral

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.