Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Peter Johansson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01681771
First received: August 30, 2012
Last updated: March 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
Heart Failure
Depressive Symptoms
Behavioral: Cognitive behaviour therapy
Behavioral: Discussion group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Change from baseline to 9 weeks as well as 6 and 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681771

Contacts
Contact: Peter Johansson, PhD +46-0702-582795 peter.johansson@aries.vokby.se
Contact: Johan Lundgren, Nurse johan.lundgren@liu.se

Locations
Sweden
Deparment of Cardiology, University Hospital of Linköping Recruiting
Linköping, Sweden, 581 85
Contact: Peter Johansson, Assoc.Prof       peter.johansson@aries.vokby.se   
Sub-Investigator: Johan Lundgren, Phd student         
Principal Investigator: Peter Johansson, PhD         
University Hospital of Linköping Recruiting
Linköping, Sweden, 581 85
Contact: Peter Johansson, Assoicate professor    +460702 582795    peter.johansson@aries.vokby.se   
Sub-Investigator: Johan Lundgren, Doctoral student         
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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
  More Information

No publications provided

Responsible Party: Peter Johansson, Nurse, Assoc. Prof, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01681771     History of Changes
Other Study ID Numbers: FORSS-221791
Study First Received: August 30, 2012
Last Updated: March 12, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014