Back to resultsInternet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
Primary Purpose
Heart Failure, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behaviour therapy
Discussion group
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Deparment of Cardiology, University Hospital of Linköping
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cogntive behaviour therapy
Discussion group
Arm Description
Internet based Cognitive behaviour therapy during 9 weeks
Internet moderated discussion group during 9 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01681771
First Posted
August 30, 2012
Last Updated
February 28, 2019
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT01681771
Brief Title
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Depressive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cogntive behaviour therapy
Arm Type
Experimental
Arm Description
Internet based Cognitive behaviour therapy during 9 weeks
Arm Title
Discussion group
Arm Type
Active Comparator
Arm Description
Internet moderated discussion group during 9 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behaviour therapy
Intervention Description
Internet based, weekly home task and weekly feedback provided by health care professional.
Intervention Type
Behavioral
Intervention Name(s)
Discussion group
Intervention Description
Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
Primary Outcome Measure Information:
Title
Depressive Symptoms
Description
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.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johansson, Assoc. Prof
Organizational Affiliation
Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deparment of Cardiology, University Hospital of Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27489077
Citation
Lundgren JG, Dahlstrom O, Andersson G, Jaarsma T, Karner Kohler A, Johansson P. The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Aug 3;18(8):e194. doi: 10.2196/jmir.5556.
Results Reference
derived
Learn more about this trial
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
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