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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 is a Phase 2 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 46 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01035294
The ClinicalTrials.gov registry entry for NCT01035294 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01035294 reports 0 study locations.
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.
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