Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152763
Status:
COMPLETED
Last Update Posted:
2011-01-28
First Post:
2005-09-07
Brief Title:
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie anti-tachycardia pace terminations and shocks and
3 to explore if the psychosocial intervention results in less need for appropriate ICD therapies
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 ie 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 ie 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 n109 OR usual cardiac care plus CBT n109 Participants are recruited from two hospitals in Toronto that perform ICD implants St Michaels 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 ie anti-tachycardia pacing terminations and DC shocks
Inclusion Criteria
Patients from either Toronto General hospital or St Michaels 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
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 ie 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 n109 OR usual cardiac care plus CBT n109 Participants are recruited from two hospitals in Toronto that perform ICD implants St Michaels 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 ie anti-tachycardia pacing terminations and DC shocks
Inclusion Criteria
Patients from either Toronto General hospital or St Michaels 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant number NA 5170 | None | None | None |