Psychological Support for Patients With an Implantable Cardioverter Defibrillator

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University Health Network, Toronto

Status and phase

Completed
Phase 3

Conditions

Depression
Anxiety

Treatments

Behavioral: Cognitive Behaviour Therapy (CBT)
Other: Usual Cardiac Care (UCC)

Study type

Interventional

Funder types

Other

Identifiers

NCT00152763
Grant number NA 5170
NA 5170

Details and patient eligibility

About

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

Full 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: to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD, to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and 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 or primary prevention of SCD if their underlying heart disease was hypertrophic cardiomyopathy. 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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

193 participants in 4 patient groups

Cognitive Behavior Therapy - males
Experimental group
Description:
Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the males.
Treatment:
Behavioral: Cognitive Behaviour Therapy (CBT)
Cognitive Behavior Therapy - females
Experimental group
Description:
Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the females.
Treatment:
Behavioral: Cognitive Behaviour Therapy (CBT)
Usual Cardiac Care - Males
Active Comparator group
Description:
The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was just for males randomized.
Treatment:
Other: Usual Cardiac Care (UCC)
Usual Cardiac Care - females
Active Comparator group
Description:
The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was for females randomized.
Treatment:
Other: Usual Cardiac Care (UCC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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