Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

Not Applicable

Completed

• Conditions: Heart Failure; Depressive Symptoms
• Interventions: Behavioral: Cognitive behaviour therapy; Behavioral: Discussion group

• Registration Number: NCT01681771
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Study Start: 2014-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-10-25
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Results First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cogntive behaviour therapy	Cognitive behaviour therapy	Internet based Cognitive behaviour therapy during 9 weeks
Discussion group	Cognitive behaviour therapy	Internet moderated discussion group during 9 weeks
Discussion group	Discussion group	Internet moderated discussion group during 9 weeks

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	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.

Trial Locations

Locations (1)

Deparment of Cardiology, University Hospital of Linköping; 🇸🇪 Linköping, Sweden