Positive Therapy for Autonomic Function & Mood in ICD Patients (PAM-ICD)
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ClinicalTrials.gov Identifier: NCT02088619 |
Recruitment Status :
Completed
First Posted : March 17, 2014
Last Update Posted : October 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ventricular Arrhythmia Implantable Cardioverter Defibrillator | Behavioral: Quality of Life Therapy (QOLT) Behavioral: Heart Healthy Education (HHE) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Quality of Life Therapy (QOLT)
Positive emotion-focused cognitive behavioral psychotherapy
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Behavioral: Quality of Life Therapy (QOLT) |
Active Comparator: Heart Healthy Education (HHE)
Heart healthy education program
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Behavioral: Heart Healthy Education (HHE) |
- 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
- 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
- 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
- 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
- Frequency of ICD therapies between 3-months and 9-months [ Time Frame: 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 [ Time Frame: 9-months ]Index of parasympathetic activity; obtained from 24-hour Holter recording
- Florida Shock Anxiety Scale [ Time Frame: 3 months ]
- Florida Patient Acceptance Scale [ Time Frame: 3-months ]
- Emotions Questionnaire [ Time Frame: 3-months ]
- Center for Epidemiologic Studies - Depression Scale (CES-D) [ Time Frame: 3-months ]
- State Trait Anxiety Inventory (STAI) [ Time Frame: 3-months ]
- Life Orientation Test - Revised (LOT-R) [ Time Frame: 3-months ]
- Positive and Negative Affect Schedule (PANAS) [ Time Frame: 3-months ]
- Satisfaction with Life Scale (SWLS) [ Time Frame: 3-months ]
- Quality of Life Inventory (QOLI) [ Time Frame: 3-months ]
- Short-Form Health Survey-36 (SF-36) [ Time Frame: 3-months ]
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 3-months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088619
United States, South Carolina | |
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Eva R Serber, PhD | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT02088619 |
Other Study ID Numbers: |
Pro00028869 1R34HL107733-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 17, 2014 Key Record Dates |
Last Update Posted: | October 2, 2017 |
Last Verified: | September 2017 |
psychological wellbeing anxiety depression autonomic functioning |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |