Journeys to Wellness: A Transplant Candidate Study
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: tMBSR; Support group
Intervention description: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8.; The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mindfulness; Quality of life; Transplantation; Renal disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.