Implantable Cardioverter Defibrillator, Ventricular Arrhythmia
Conditions
Keywords
psychological wellbeing, anxiety, depression, autonomic functioning
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.
Interventions
BEHAVIORALQuality of Life Therapy (QOLT)
BEHAVIORALHeart Healthy Education (HHE)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales; 3. Able to read and write English 4. Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.
Exclusion criteria
1. \>5% atrial or ventricular pacing; 2. Sinus node dysfunction; 3. Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed). 4. Long QT syndrome; and other channelopathies such as Brugada syndrome; 5. Hypertrophic cardiomyopathy; 6. Neurocognitive or cognitive impairments; 7. Severe psychopathology that warrants intensive treatment; 8. Participation in another research trial; and 9. Currently in psychological or psychiatric treatment. 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Positive and Negative Affect Schedule (PANAS) | 3-months |
| Satisfaction with Life Scale (SWLS) | 3-months |
| Florida Shock Anxiety Scale | 3 months |
| Short-Form Health Survey-36 (SF-36) | 3-months |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | 3-months |
| Quality of Life Inventory (QOLI) | 3-months |
| Florida Patient Acceptance Scale | 3-months |
| Emotions Questionnaire | 3-months |
| Center for Epidemiologic Studies - Depression Scale (CES-D) | 3-months |
| State Trait Anxiety Inventory (STAI) | 3-months |
| Life Orientation Test - Revised (LOT-R) | 3-months |
Countries
United States
Outcome results
None listed