At a glance
ClinicalIndex Comparison Record- ✓Patients with coronary heart disease receiving their first ICD implant for secondary prevention of SCD
- ✓Patients receiving first ICD implant for primary prevention of SCD with underlying hypertrophic cardiomyopathy
- ✕Unable to read or understand English
- ✕Evidence of psychosis, dementia, or cognitive impairment documented in hospital records
- ✕Receiving ICD for primary prevention (except HCM patients)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
In Brief
A Phase 3 clinical trial evaluating Cognitive Behaviour Therapy (CBT) and Usual Cardiac Care (UCC) for Anxiety and Depression. Completed, enrolled 193 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Usual cardiac care (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.