Phase 3
Completed N=55
Journeys to Wellness: A Transplant Candidate Study
Source: ClinicalTrials.gov NCT01254214 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: State-Trait Anxiety Inventory — 42.1; 37.8; 40.6; 34.8 units on a scale
◆ Published Evidence
Established
67citations · ~7 / year
Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation.
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.
Linked Publications (3)
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Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation.
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Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility.
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Interventions for fatigue in people with kidney failure requiring dialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY State-Trait Anxiety Inventory |
42.1; 37.8; 40.6; 34.8; 41.2; 38.1 | — |
| SECONDARY Short Form -12 MCS |
48.9; 49.6; 48.3; 51.1; 49.7; 46.7 | — |
| SECONDARY SF-12 PCS |
34.5; 38.1; 38.1; 38.3; 33.2; 38.5 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
7.4; 6.3; 7.3; 6.1; 8.5; 7.1 | — |
| SECONDARY Center for Epidemiologic Studies Depression Scale (CESD) |
15.4; 11.1; 14.7; 9.1; 16.9; 11.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01254214) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.