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

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Arrhythmia; Implantable Cardioverter Defibrillator
• Intervention / Treatment: Behavioral: Quality of Life Therapy (QOLT); Behavioral: Heart Healthy Education (HHE)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Eva R Serber, PhD, Medical University of South Carolina

Publications and helpful links

General Publications

• Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: depression; anxiety; psychological wellbeing; autonomic functioning
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Pro00028869; 1R34HL107733-01A1 (U.S. NIH Grant/Contract)