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	Behavior: Cognitive behaviour therapy	Phase III

Further Study Details: 

Primary Outcomes: Psychological distress (symptoms of anxiety and depression); Quality of life
Secondary Outcomes: ICD therapies
Expected Total Enrollment:  218

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 prohibted 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. 4.4 Exclusion Criteria:(i) not able to read or understand English; (ii) evidence of psychosis, dementia or cognitive impairment as documented in the patients’ hospital records; (iii) or (iv) receiving an ICD for primary prevention of ICD.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

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Exclusion Criteria:(i) Not able to read or understand English; (ii) evidence of psychosis, dementia or cognitive impairment as documented in the patients’ hospital records; (iii) or (iv) receiving an ICD for primary prevention of ICD.

Please refer to this study by ClinicalTrials.gov identifier  NCT00152763

Jane Irvine, D.Phil.      (416) 340-4800  Ext. 3299    jane.irvine@utoronto.ca
Paul Ritvo, Ph.D.      (416) 971-5100  Ext. 3203    paul.ritvo@utoronto.ca

Canada, Ontario
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting

Study chairs or principal investigators

Jane Irvine, D.Phil.,  Principal Investigator,  University Health Network - Toronto General Hospital   

Study ID Numbers:  NA 5170; Grant number NA 5170
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152763
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13