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OpenTrials
Completed

NCT Number: NCT02088619

Positive Therapy for Autonomic Function & 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life Therapy (QOLT)

Behavioral

Heart Healthy Education (HHE)

Behavioral

Primary outcomes

  1. Frequency of arrhythmias between baseline and 3-months

    Time frame: 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

  2. Frequency of arrhythmias between 3-months and 9-months

    Time frame: 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 outcomes

  1. Frequency of ICD therapies between baseline and 3-months

    Time frame: 3-months

    Obtained from ICD interrogation reports from recording between baseline and 3-months

  2. Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months

    Time frame: 3-months

    Index of parasympathetic activity; obtained from 24-hour Holter recording

  3. Frequency of ICD therapies between 3-months and 9-months

    Time frame: 9-months

    Obtained from ICD interrogation reports between 3- and 9-months

  4. Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months

    Time frame: 9-months

    Index of parasympathetic activity; obtained from 24-hour Holter recording

Other outcomes

  1. Florida Shock Anxiety Scale

    Time frame: 3 months

  2. Florida Patient Acceptance Scale

    Time frame: 3-months

  3. Emotions Questionnaire

    Time frame: 3-months

  4. Center for Epidemiologic Studies - Depression Scale (CES-D)

    Time frame: 3-months

  5. State Trait Anxiety Inventory (STAI)

    Time frame: 3-months

  6. Life Orientation Test - Revised (LOT-R)

    Time frame: 3-months

  7. Positive and Negative Affect Schedule (PANAS)

    Time frame: 3-months

  8. Satisfaction with Life Scale (SWLS)

    Time frame: 3-months

  9. Quality of Life Inventory (QOLI)

    Time frame: 3-months

  10. Short-Form Health Survey-36 (SF-36)

    Time frame: 3-months

  11. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 3-months

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

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

Registry information

Official study title

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

Acronym: PAM-ICD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2014
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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