Journeys to Wellness: A Transplant Candidate Study
Completed · Phase 3
Conditions studied: End-stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT01254214
- Run by
- University of Minnesota
- People needed
- 63
- Starts
- 2010-02-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN
- Aged 18 or older
- English-speaking
- Literate
- Mentally intact
- Able to use the telephone to participate in 6 weekly teleconferences
- Able to attend 2 in-person classes in a Minnesota Metro area
- Able to comply with study monitoring requirements
- Receiving standard medical follow-up care
- Willing to complete the informed consent process
You may not qualify if…
- Prior transplant
- Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)
- Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse
- Not expected to be on the waiting list > 3 months (e.g., acceptable living donor has been identified and scheduled)
- Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)
- Not receiving standard medical care.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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