Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

February 28, 2019 updated by: Peter Johansson, University Hospital, Linkoeping

Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms

The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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
      • Linköping, Sweden, 581 85
        • Deparment of Cardiology, University Hospital of Linköping

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:

  • > 18 years
  • have time to participate in the study,
  • treatment for HF according to the European Society of Cardiology guidelines2
  • stable HF (NYHA class I-III) and not being hospitalized for HF the latest month
  • signs of suffering of depressive symptoms (Patient Health Questionnaire-9 >9 points

Exclusion Criteria:

  • severe HF (NYHA IV) or another severe chronic life threatening disease.
  • severe depression assessed to need hospital care

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: Cogntive behaviour therapy
Internet based Cognitive behaviour therapy during 9 weeks
Behavioral: Cognitive behaviour therapy
Internet based, weekly home task and weekly feedback provided by health care professional.
Active Comparator: Discussion group
Internet moderated discussion group during 9 weeks
Behavioral: Cognitive behaviour therapy
Internet based, weekly home task and weekly feedback provided by health care professional.
Behavioral: Discussion group
Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: 9 weeks
Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression.
9 weeks

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, Assoc. Prof, Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping

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 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORSS-221791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Heart Failure

Clinical Trials on Cognitive behaviour therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe