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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL107733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality of Life Therapy (QOLT) | Experimental | Positive emotion-focused cognitive behavioral psychotherapy |
|
| Heart Healthy Education (HHE) | Active Comparator | Heart healthy education program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of Life Therapy (QOLT) | Behavioral |
| ||
| Heart Healthy Education (HHE) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-months |
| 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 | 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ICD therapies between baseline and 3-months | Obtained from ICD interrogation reports from recording between baseline and 3-months | 3-months |
| Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Florida Shock Anxiety Scale | 3 months | |
| Florida Patient Acceptance Scale | 3-months | |
| Emotions Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva R Serber, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Behavioral |
|
Index of parasympathetic activity; obtained from 24-hour Holter recording
| 3-months |
| Frequency of ICD therapies between 3-months and 9-months | Obtained from ICD interrogation reports between 3- and 9-months | 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 | 9-months |
| 3-months |
| Center for Epidemiologic Studies - Depression Scale (CES-D) | 3-months |
| State Trait Anxiety Inventory (STAI) | 3-months |
| Life Orientation Test - Revised (LOT-R) | 3-months |
| Positive and Negative Affect Schedule (PANAS) | 3-months |
| Satisfaction with Life Scale (SWLS) | 3-months |
| Quality of Life Inventory (QOLI) | 3-months |
| Short-Form Health Survey-36 (SF-36) | 3-months |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | 3-months |