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Psychological Support for Patients With an Implantable Cardioverter Defibrillator

This study is ongoing, but not recruiting participants.

Sponsored by: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152763
  Purpose

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

  1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
  2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
  3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

Condition Intervention Phase
Anxiety
Depression
Behavioral: Cognitive behaviour therapy
Phase III

MedlinePlus related topics:   Anxiety    Depression    Pacemakers and Implantable Defibrillators   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Psychological Support for Patients With an Implantable Cardioverter Defibrillator

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Psychological distress (symptoms of anxiety and depression)
  • Quality of life

Secondary Outcome Measures:
  • ICD therapies

Estimated Enrollment:   218
Study Start Date:   October 2003
Estimated Study Completion Date:   February 2008

Detailed Description:

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

  1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
  2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
  3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

This study will randomize 218 ICD patients to receive either usual cardiac care (n=109) OR usual cardiac care plus CBT (n=109). Participants are recruited from two hospitals in Toronto that perform ICD implants (St. Michael's Hospital and the Toronto General Hospital). Counselling follows a CBT manual and involves both face-to-face sessions and telephone sessions. The telephone is employed as a means to deliver therapy as at least half of our ICD subjects reside outside of Toronto and all patients are prohibited from driving an automobile for the first six months following ICD implant. Outcome is assessed 6 and 12-months following the date of randomization and include measures of psychological function and quality of life. Secondary outcome is frequency of ICD therapies over follow-up (i.e., anti-tachycardia pacing terminations and DC shocks).

Inclusion Criteria:

  • Patients from either Toronto General hospital or St. Michael’s Hospital who have coronary heart disease,
  • Receiving their first ICD implant for secondary prevention of SCD.

Exclusion Criteria:

  • Not able to read or understand English;
  • Evidence of psychosis, dementia or cognitive impairment as documented in the patients’ hospital records;
  • Receiving an ICD for primary prevention of ICD.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients from either Toronto General hospital or St. Michael’s Hospital who have coronary heart disease,
  • Receiving their first ICD implant for secondary prevention of SCD.

Exclusion Criteria:

  • Not able to read or understand English;
  • Evidence of psychosis, dementia or cognitive impairment as documented in the patients’ hospital records;
  • Receiving an ICD for primary prevention of ICD.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152763

Locations
Canada, Ontario
Toronto General Hospital    
      Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators
University Health Network, Toronto

Investigators
Principal Investigator:     Jane Irvine, D.Phil.     University Health Network, Toronto General Hospital    
  More Information


Study ID Numbers:   NA 5170, Grant number NA 5170
First Received:   September 7, 2005
Last Updated:   May 15, 2007
ClinicalTrials.gov Identifier:   NCT00152763
Health Authority:   Canada: Health Canada

Keywords provided by University Health Network, Toronto:
health anxiety  

Study placed in the following topic categories:
Depression
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 07, 2008




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