Positive Therapy for Autonomic Function & Mood in ICD Patients

NCT02088619 | Completed

• 2 other identifiers: Pro000288691R34HL107733-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrhythmia; Implantable Cardioverter Defibrillator

Keywords

psychological wellbeing; anxiety; depression; autonomic functioning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Other Outcomes (11)

• Florida Shock Anxiety Scale

  3 months

• Florida Patient Acceptance Scale

  3-months

• Emotions Questionnaire

  3-months

Study Arms (2)

Quality of Life Therapy (QOLT)

EXPERIMENTAL

Positive emotion-focused cognitive behavioral psychotherapy

Behavioral: Quality of Life Therapy (QOLT)

Heart Healthy Education (HHE)

ACTIVE COMPARATOR

Heart healthy education program

Behavioral: Heart Healthy Education (HHE)

Interventions

Quality of Life Therapy (QOLT) BEHAVIORAL

Quality of Life Therapy (QOLT)

Heart Healthy Education (HHE) BEHAVIORAL

Heart Healthy Education (HHE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eva R Serber, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 17, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

US (1)