Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Depressive Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cogntive behaviour therapy
Internet based Cognitive behaviour therapy during 9 weeks
Intervention: Cognitive behaviour therapy (Behavioral)
Discussion group
Internet moderated discussion group during 9 weeks
Intervention: Cognitive behaviour therapy (Behavioral)
Discussion group
Internet moderated discussion group during 9 weeks
Intervention: Discussion group (Behavioral)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Johansson
Nurse, Assoc. Prof
University Hospital, Linkoeping