Positive Therapy for Autonomic Function & Mood in ICD Patients

Study Overview
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Brief Summary
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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.

Official Title
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Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

Conditions
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Ventricular Arrhythmia, Implantable Cardioverter Defibrillator

Intervention / Treatment
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* Behavioral: Quality of Life Therapy (QOLT)
* Behavioral: Heart Healthy Education (HHE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: >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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quality of Life Therapy (QOLT)<br>Positive emotion-focused cognitive behavioral psychotherapy | Behavioral: Quality of Life Therapy (QOLT)<br> <br> |
| Active Comparator: Heart Healthy Education (HHE)<br>Heart healthy education program | Behavioral: Heart Healthy Education (HHE)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of arrhythmias between baseline and 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 | 3-months | 
| Frequency of arrhythmias between 3-months and 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 | 9-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of ICD therapies between baseline and 3-months | Obtained from ICD interrogation reports from recording between baseline and 3-months | 3-months | 
| Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months | Index of parasympathetic activity; obtained from 24-hour Holter recording | 3-months | 
| Frequency of ICD therapies between 3-months and 9-months | Obtained from ICD interrogation reports between 3- and 9-months | 9-months | 
| Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months | Index of parasympathetic activity; obtained from 24-hour Holter recording | 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological wellbeing, anxiety, depression, autonomic functioning