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NCT02088619 · ClinicalTrials.gov registry record · NA
Positive Therapy for Autonomic Function & Mood in ICD Patients
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT02088619: Completed NA study, sponsored by Medical University of South Carolina.
NCT02088619 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088619, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Quality of Life Therapy (QOLT)
- BEHAVIORAL Heart Healthy Education (HHE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-01 |
| Phase | NA |
What the finished NCT02088619 record still lists
NCT02088619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Quality of Life Therapy (QOLT) is the first listed.
NCT02088619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02088619 about?
NCT02088619 is a clinical study titled "Positive Therapy for Autonomic Function & Mood in ICD Patients". 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 si...
What is the current status of trial NCT02088619?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2014-07. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02088619?
The interventions under investigation include: Quality of Life Therapy (QOLT) (BEHAVIORAL), Heart Healthy Education (HHE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02088619?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02088619's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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