Phase 3 N=193 Randomized Single-blind Treatment

Psychological Support for Patients With an Implantable Cardioverter Defibrillator

Anxiety · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00152763 ↗

Enrolled (actual)

193

Serious AEs

4.2%

Results posted

Jan 2011

Primary outcome: Primary: Hospital Anxiety and Depression Scale - Depression Scale at Baseline — 4.70; 7.47; 5.35; 4.12 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cognitive Behaviour Therapy (CBT) (Behavioral); Usual Cardiac Care (UCC) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Health Network, Toronto
Primary completion: Sep 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Anxiety and Depression Scale - Depression Scale at Baseline	4.70; 7.47; 5.35; 4.12	—
PRIMARY Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up	4.21; 4.86; 5.50; 3.82	—
PRIMARY Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up	4.52; 4.67; 5.87; 4.15	—
PRIMARY Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline	6.53; 9.32; 7.70; 4.80	—
PRIMARY Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up	6.06; 7.28; 6.83; 4.69	—
PRIMARY Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up	6.06; 8.00; 7.25; 4.43	—
PRIMARY Impact of Events Scale-Revised - Total Score at Baseline	0.81; 1.56; 1.20; 0.63	—
PRIMARY Impact of Events Scale-Revised - Total Score at 6-months Follow-up	0.70; 0.76; 0.68; 0.54	—
PRIMARY Impact of Events Scale-Revised - Total Score at 12-months Follow-up	0.70; 0.69; 0.82; 0.46	—
PRIMARY Impact of Events Scale-Revised - Intrusiveness Scale at Baseline	0.80; 1.53; 1.25; 0.61	—
PRIMARY Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up	0.61; 0.82; 0.73; 0.56	—
PRIMARY Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up	0.62; 0.64; 0.80; 0.42	—
PRIMARY Impact of Events Scale-Revised - Avoidance Scale at Baseline	0.84; 1.68; 1.25; 0.64	—
PRIMARY Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up	0.86; 0.77; 0.74; 0.55	—
PRIMARY Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up	0.82; 0.84; 0.98; 0.57	—
PRIMARY Impact of Event Scale-Revised Hyperarousal Scale at Baseline	0.78; 1.40; 1.07; 0.64	—
PRIMARY Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up	0.61; 0.64; 0.56; 0.52	—
PRIMARY Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up	0.64; 0.57; 0.67; 0.39	—
PRIMARY Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline	0.98; 1.17; 1.23; 0.83	—
PRIMARY Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up	0.92; 1.04; 1.07; 0.84	—
PRIMARY Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up	0.98; 1.13; 1.07; 0.93	—
SECONDARY SF-36 Mental Component Summary Scale at Baseline	45.90; 37.44; 42.33; 49.84	—
SECONDARY SF-36 Mental Component Summary Scale at 6-months Follow-up	48.73; 43.82; 45.67; 51.32	—
SECONDARY SF-36 Mental Component Summary Scale at 12-months Follow-up	49.92; 46.26; 41.58; 51.61	—
SECONDARY SF-36 Physical Component Summary Score at Baseline	39.19; 36.13; 37.60; 38.85	—
SECONDARY SF-36 Physical Component Summary Score at 6-months Follow-up	42.54; 41.46; 41.22; 42.69	—
SECONDARY SF-36 Physical Component Summary Score at 12-months Follow-up	42.65; 42.70; 42.82; 41.54	—
SECONDARY Percentage of Participants Who Received ICD Therapies	30.5; 31.9	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00152763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.