MedDataX Logo

Positive Therapy for Autonomic Function & Mood in ICD Patients

NCT ID: NCT02088619

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Arrhythmia Implantable Cardioverter Defibrillator

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quality of Life Therapy (QOLT)

Positive emotion-focused cognitive behavioral psychotherapy

Group Type EXPERIMENTAL

Quality of Life Therapy (QOLT)

Intervention Type BEHAVIORAL

Heart Healthy Education (HHE)

Heart healthy education program

Group Type ACTIVE_COMPARATOR

Heart Healthy Education (HHE)

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality of Life Therapy (QOLT)

Intervention Type BEHAVIORAL

Heart Healthy Education (HHE)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eva R Serber, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R34HL107733-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00028869

Identifier Type: -

Identifier Source: org_study_id