Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
Charleston, South Carolina, 29425, United States
NCT Number: NCT02088619
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 3-months
Obtained from ICD interrogation reports from recording between baseline and 3-months
Time frame: 3-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time frame: 9-months
Obtained from ICD interrogation reports between 3- and 9-months
Time frame: 9-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time frame: 3 months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Time frame: 3-months
Medical University of South Carolina
Other
Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
Acronym: PAM-ICD
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