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NCT01254214 · ClinicalTrials.gov registry record · Phase 3
Journeys to Wellness: A Transplant Candidate Study
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT01254214 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 63 participants.
The verdict
NCT01254214, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.
Interventions
- BEHAVIORAL Support group
- BEHAVIORAL tMBSR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01254214
The ClinicalTrials.gov registry entry for NCT01254214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Support group is the first listed.
NCT01254214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01254214 about?
NCT01254214 is a clinical study titled "Journeys to Wellness: A Transplant Candidate Study". The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life fo...
What is the current status of trial NCT01254214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2010-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01254214?
The interventions under investigation include: Support group (BEHAVIORAL), tMBSR (BEHAVIORAL).
Who is sponsoring clinical trial NCT01254214?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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