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NCT01035294 · ClinicalTrials.gov registry record · Phase 2
A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
A Phase 2 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01035294: Completed Phase 2 study, sponsored by University of Massachusetts, Worcester.
NCT01035294 is a Phase 2 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01035294, a Phase 2 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness-based behavioral intervention combining breathing and other relaxation exercises on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter defibrillator. This study will pilot test the feasibility and preliminary efficacy of a mindfulness-based intervention intended to improve mindfulness and anxiety levels in ICD (Implantable Cardioverter Defibrillators) patients. A randomized controlled study design will be used, in which an 8 session phone-delivered mindfulness intervention will be compared to a usual care condition among consecutive candidates for ICD procedures. The study will be conducted at the Electrophysiology (EPS) Unit at the UMass Memorial Medical Center. Assessments will be performed at baseline and at the end of the intervention (9 weeks after enrollment).
Interventions
- BEHAVIORAL usual care
- BEHAVIORAL mindfulness based intervention (MBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT01035294 record still lists
NCT01035294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01035294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01035294 about?
NCT01035294 is a clinical study titled "A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients". The purpose of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness-based behavioral intervention combining breathing and other relaxation exercises on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter defibrillator. This study ...
What is the current status of trial NCT01035294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2009-07. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01035294?
The interventions under investigation include: usual care (BEHAVIORAL), mindfulness based intervention (MBI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01035294?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01035294's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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