Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Frequency of arrhythmias between 3-months and 9-months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •>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.
研究组 & 干预措施
Quality of Life Therapy (QOLT)
Positive emotion-focused cognitive behavioral psychotherapy
干预措施: Quality of Life Therapy (QOLT) (Behavioral)
Heart Healthy Education (HHE)
Heart healthy education program
干预措施: Heart Healthy Education (HHE) (Behavioral)
结局指标
主要结局
Frequency of arrhythmias between 3-months and 9-months
时间窗: 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
时间窗: 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
次要结局
- Frequency of ICD therapies between baseline and 3-months(3-months)
- Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months(3-months)
- Frequency of ICD therapies between 3-months and 9-months(9-months)
- Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months(9-months)