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Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

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ClinicalTrials.gov Identifier: NCT01681771
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : May 17, 2016
Information provided by (Responsible Party):
Peter Johansson, University Hospital, Linkoeping

August 30, 2012
September 10, 2012
May 17, 2016
February 2014
June 2015   (Final data collection date for primary outcome measure)
Depressive symptoms [ Time Frame: Change from baseline to 9 weeks as well as 6 and 12 months ]
Depressive Symptoms measured with Patient Health Questionnaire-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
Same as current
Complete list of historical versions of study NCT01681771 on ClinicalTrials.gov Archive Site
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Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms
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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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heart Failure
  • Depressive Symptoms
  • Behavioral: Cognitive behaviour therapy
    Internet based, weekly home task and weekly feedback provided by health care professional.
  • Behavioral: 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.
  • Experimental: Cogntive behaviour therapy
    Internet based Cognitive behaviour therapy during 9 weeks
    Intervention: Behavioral: Cognitive behaviour therapy
  • Active Comparator: Discussion group
    Internet moderated discussion group during 9 weeks
    • Behavioral: Cognitive behaviour therapy
    • Behavioral: Discussion group
Lundgren JG, Dahlström Ö, Andersson G, Jaarsma T, Kärner Köhler 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Peter Johansson, University Hospital, Linkoeping
University Hospital, Linkoeping
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Principal Investigator: Peter Johansson, Assoc. Prof Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping
University Hospital, Linkoeping
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP