Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681771
• Other study ID #: FORSS-221791
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Heart Failure

Intervention

Behavioral:
• Cognitive behaviour therapy
Internet based, weekly home task and weekly feedback provided by health care professional.
• 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.

Locations

Country	Name	City	State
Sweden	Deparment of Cardiology, University Hospital of Linköping	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	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