Skip to main content
OpenTrials
Completed

NCT Number: NCT02778074

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkoping University

Norrköping, 601 74, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet cognitive behavioural therapy

Behavioral

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.

Other names: I-CBT

Moderated Discussion Forum

Behavioral

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.

Primary outcomes

  1. Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Score at 9 weeks follow-up

    The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 19, 2016
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.