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Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01681771
Recruitment Status : Completed
First Posted : September 10, 2012
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Johansson, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Depressive Symptoms Behavioral: Cognitive behaviour therapy Behavioral: Discussion group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Cogntive behaviour therapy
Internet based Cognitive behaviour therapy during 9 weeks
Behavioral: Cognitive behaviour therapy
Internet based, weekly home task and weekly feedback provided by health care professional.

Active Comparator: Discussion group
Internet moderated discussion group during 9 weeks
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681771


Locations
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Sweden
Deparment of Cardiology, University Hospital of Linköping
Linköping, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Johansson, Nurse, Assoc. Prof, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01681771     History of Changes
Other Study ID Numbers: FORSS-221791
First Posted: September 10, 2012    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Depression
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases