Positive Therapy for Autonomic Function & Mood in ICD Patients

Completed · Not applicable

Conditions studied: Ventricular Arrhythmia, Implantable Cardioverter Defibrillator

In brief

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.

Key facts

Study ID

NCT02088619

Run by

Medical University of South Carolina

People needed

29

Starts

2014-07-01

Expected to finish

2017-01-01

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• >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.

Where it is running

• Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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