Clinical trial NCT00152763: Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Official title: Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Depression
Keywords: health anxiety
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility 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 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale - Depression Scale at Baseline
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Impact of Events Scale-Revised - Total Score at Baseline
timeFrame: Baseline
measure: Impact of Events Scale-Revised - Total Score at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Impact of Events Scale-Revised - Total Score at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
timeFrame: Baseline
measure: Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Impact of Events Scale-Revised - Avoidance Scale at Baseline
timeFrame: Baseline
measure: Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Impact of Event Scale-Revised Hyperarousal Scale at Baseline
timeFrame: Baseline
measure: Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
timeFrame: Baseline
measure: Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
Secondary outcomes:
measure: SF-36 Mental Component Summary Scale at Baseline
timeFrame: Baseline
measure: SF-36 Mental Component Summary Scale at 6-months Follow-up
timeFrame: Six-months follow-up
measure: SF-36 Mental Component Summary Scale at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: SF-36 Physical Component Summary Score at Baseline
timeFrame: Baseline
measure: SF-36 Physical Component Summary Score at 6-months Follow-up
timeFrame: Six-months follow-up
measure: SF-36 Physical Component Summary Score at 12-months Follow-up
timeFrame: Twelve-months follow-up
measure: Percentage of Participants Who Received ICD Therapies
timeFrame: 12-months follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto General Hospital
name: Jane Irvine, D.Phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irvine, J. Stanley, J., Ong, L., Cribbie, R., Ritvo, P., Katz, J., Dorian, P., O'Donnell, S., Harris, L., Cameron, D., Hill, A., Newman, D., Johnson, S. N., Bilanovic, A. Sears, S F. Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients, Journal of Cognitive Psychotherapy, 2010; 24(4) (November), 243-264.
citation: Ford J, Rosman L, Wuensch K, Irvine J, Sears SF. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial. J Trauma Stress. 2016 Aug;29(4):388-92. doi: 10.1002/jts.22111. Epub 2016 Jul 14.
citation: Irvine J, Firestone J, Ong L, Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S, Bilanovic A, Hill A, O'Donnell S, Sears S Jr. A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator. Psychosom Med. 2011 Apr;73(3):226-33. doi: 10.1097/PSY.0b013e31820afc63. Epub 2011 Feb 14.