Status:
COMPLETED
Journeys to Wellness: A Transplant Candidate Study
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Primary Aims 1. Test the efficacy of a telephone-adapted Mindfulness-Based Stress Reduction (tMBSR) program to reduce symptoms and improve the quality of life of kidney transplant candidates by 8-wee...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01254214
Start Date
February 1 2010
End Date
August 1 2015
Last Update
October 31 2016
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455