Positive Therapy for Autonomic Function & Mood in ICD Patients
- Conditions
- Implantable Cardioverter DefibrillatorVentricular Arrhythmia
- Interventions
- Behavioral: Quality of Life Therapy (QOLT)Behavioral: Heart Healthy Education (HHE)
- Registration Number
- NCT02088619
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
- Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
- Able to read and write English
- Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.
- >5% atrial or ventricular pacing;
- Sinus node dysfunction;
- Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
- Long QT syndrome; and other channelopathies such as Brugada syndrome;
- Hypertrophic cardiomyopathy;
- Neurocognitive or cognitive impairments;
- Severe psychopathology that warrants intensive treatment;
- Participation in another research trial; and
- Currently in psychological or psychiatric treatment.
- Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quality of Life Therapy (QOLT) Quality of Life Therapy (QOLT) Positive emotion-focused cognitive behavioral psychotherapy Heart Healthy Education (HHE) Heart Healthy Education (HHE) Heart healthy education program
- Primary Outcome Measures
Name Time Method Frequency of arrhythmias between 3-months and 9-months 9-months Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at \>120 BPM ) plus arrhythmias detected by the ICD
Frequency of arrhythmias between baseline and 3-months 3-months Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at \>120 beats per minute \[BPM\] ) plus arrhythmias detected by the ICD
- Secondary Outcome Measures
Name Time Method Frequency of ICD therapies between baseline and 3-months 3-months Obtained from ICD interrogation reports from recording between baseline and 3-months
Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months 3-months Index of parasympathetic activity; obtained from 24-hour Holter recording
Frequency of ICD therapies between 3-months and 9-months 9-months Obtained from ICD interrogation reports between 3- and 9-months
Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months 9-months Index of parasympathetic activity; obtained from 24-hour Holter recording
Trial Locations
- Locations (1)
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
🇺🇸Charleston, South Carolina, United States