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

November 29, 2019 updated by: Peter Johansson, University Hospital, Linkoeping

Internet-guided Cognitive Behavioural Therapy to Improve Depression in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Norrköping, Sweden, 601 74
        • Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet Cognitive Behavioural Therapy
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.
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.
Other Names:
  • I-CBT
Placebo Comparator: Moderated discussion forum
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Score at 9 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Peter Johansson, PhD, Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

November 29, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-02600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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