Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

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.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Depression Depressive Symptoms Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deparment of Cardiology, University Hospital of Linköping

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cognitive Behaviour Therapy

Behavioral

Internet based, weekly home task and weekly feedback provided by health care professional.

discussion group

Behavioral

Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 10, 2012
Registry last updated: Jun 3, 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.

Completed