PAM-ICD: Positive Therapy for Autonomic Function & Mood in ICD Patients

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT02088619

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

30.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrhythmia Implantable Cardioverter Defibrillator	Behavioral: Quality of Life Therapy (QOLT) Behavioral: Heart Healthy Education (HHE)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Quality of Life Therapy (QOLT)

Positive emotion-focused cognitive behavioral psychotherapy

Behavioral: Quality of Life Therapy (QOLT)

Active Comparator: Heart Healthy Education (HHE)

Heart healthy education program

Behavioral: Heart Healthy Education (HHE)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

Florida Shock Anxiety Scale [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]
Positive and Negative Affect Schedule (PANAS) [3-months]
Satisfaction with Life Scale (SWLS) [3-months]
Quality of Life Inventory (QOLI) [3-months]
Short-Form Health Survey-36 (SF-36) [3-months]
Minnesota Living with Heart Failure Questionnaire (MLHFQ) [3-months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.