Back to resultsPositive Therapy for Autonomic Function & Mood in ICD Patients (PAM-ICD)
Primary Purpose
Ventricular Arrhythmia, Implantable Cardioverter Defibrillator
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of Life Therapy (QOLT)
Heart Healthy Education (HHE)
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Arrhythmia focused on measuring psychological wellbeing, anxiety, depression, autonomic functioning
Eligibility Criteria
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.
Sites / Locations
- Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quality of Life Therapy (QOLT)
Heart Healthy Education (HHE)
Arm Description
Positive emotion-focused cognitive behavioral psychotherapy
Heart healthy education program
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Frequency of ICD therapies between baseline and 3-months
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
Index of parasympathetic activity; obtained from 24-hour Holter recording
Frequency of ICD therapies between 3-months and 9-months
Obtained from ICD interrogation reports between 3- and 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
Full Information
NCT ID
NCT02088619
First Posted
February 18, 2014
Last Updated
September 29, 2017
Sponsor
Medical University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02088619
Brief Title
Positive Therapy for Autonomic Function & Mood in ICD Patients
Acronym
PAM-ICD
Official Title
Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmia, Implantable Cardioverter Defibrillator
Keywords
psychological wellbeing, anxiety, depression, autonomic functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quality of Life Therapy (QOLT)
Arm Type
Experimental
Arm Description
Positive emotion-focused cognitive behavioral psychotherapy
Arm Title
Heart Healthy Education (HHE)
Arm Type
Active Comparator
Arm Description
Heart healthy education program
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Therapy (QOLT)
Intervention Type
Behavioral
Intervention Name(s)
Heart Healthy Education (HHE)
Primary Outcome Measure Information:
Title
Frequency of arrhythmias between baseline and 3-months
Description
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
Time Frame
3-months
Title
Frequency of arrhythmias between 3-months and 9-months
Description
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
Time Frame
9-months
Secondary Outcome Measure Information:
Title
Frequency of ICD therapies between baseline and 3-months
Description
Obtained from ICD interrogation reports from recording between baseline and 3-months
Time Frame
3-months
Title
Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months
Description
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time Frame
3-months
Title
Frequency of ICD therapies between 3-months and 9-months
Description
Obtained from ICD interrogation reports between 3- and 9-months
Time Frame
9-months
Title
Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months
Description
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time Frame
9-months
Other Pre-specified Outcome Measures:
Title
Florida Shock Anxiety Scale
Time Frame
3 months
Title
Florida Patient Acceptance Scale
Time Frame
3-months
Title
Emotions Questionnaire
Time Frame
3-months
Title
Center for Epidemiologic Studies - Depression Scale (CES-D)
Time Frame
3-months
Title
State Trait Anxiety Inventory (STAI)
Time Frame
3-months
Title
Life Orientation Test - Revised (LOT-R)
Time Frame
3-months
Title
Positive and Negative Affect Schedule (PANAS)
Time Frame
3-months
Title
Satisfaction with Life Scale (SWLS)
Time Frame
3-months
Title
Quality of Life Inventory (QOLI)
Time Frame
3-months
Title
Short-Form Health Survey-36 (SF-36)
Time Frame
3-months
Title
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva R Serber, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.
Results Reference
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Positive Therapy for Autonomic Function & Mood in ICD Patients
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