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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02088619
First received: February 18, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention
Ventricular Arrhythmia
Implantable Cardioverter Defibrillator
Behavioral: Quality of Life Therapy (QOLT)
Behavioral: Heart Healthy Education (HHE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Frequency of arrhythmias between baseline and 3-months [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Index of parasympathetic activity; obtained from 24-hour Holter recording

  • Frequency of ICD therapies between 3-months and 9-months [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Obtained from ICD interrogation reports between 3- and 9-months

  • Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Index of parasympathetic activity; obtained from 24-hour Holter recording


Other Outcome Measures:
  • Florida Shock Anxiety Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Florida Patient Acceptance Scale [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Emotions Questionnaire [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Center for Epidemiologic Studies - Depression Scale (CES-D) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • State Trait Anxiety Inventory (STAI) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Life Orientation Test - Revised (LOT-R) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale (SWLS) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QOLI) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Short-Form Health Survey-36 (SF-36) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 3-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2014
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088619

Contacts
Contact: Eva R Serber, PhD 843-792-0686 serbere@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine Not yet recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Eva R Serber, PhD         
Sub-Investigator: Michael R Gold, MD, PhD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Eva R Serber, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02088619     History of Changes
Other Study ID Numbers: Pro00028869, 1R34HL107733-01A1
Study First Received: February 18, 2014
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
psychological wellbeing
anxiety
depression
autonomic functioning

ClinicalTrials.gov processed this record on September 18, 2014