Journeys to Wellness: A Transplant Candidate Study
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ClinicalTrials.gov Identifier: NCT01254214 |
Recruitment Status
:
Completed
First Posted
: December 6, 2010
Results First Posted
: October 31, 2016
Last Update Posted
: October 31, 2016
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Condition or disease | Intervention/treatment | Phase |
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End-stage Renal Disease | Behavioral: tMBSR Behavioral: Support group | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: tMBSR
telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
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Behavioral: tMBSR
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.
Other Name: None applicable
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Active Comparator: Support Group
The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
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Behavioral: Support group
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.
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- State-Trait Anxiety Inventory [ Time Frame: Baseline, 8 weeks, 26 weeks ]The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.
- Short Form -12 MCS [ Time Frame: baseline, 8 and 26 weeks ]Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.
- SF-12 PCS [ Time Frame: baseline, 8 weeks, 26 weeks ]Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline, 8 weeks, 26 weeks ]The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.
- Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: baseline, 8 weeks, 26 weeks ]The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254214
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Cynthia R Gross, PhD | University of Minnesota - Clinical and Translational Science Institute |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT01254214 History of Changes |
Other Study ID Numbers: |
0907S70361 2P01DK013083 ( U.S. NIH Grant/Contract ) |
First Posted: | December 6, 2010 Key Record Dates |
Results First Posted: | October 31, 2016 |
Last Update Posted: | October 31, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Mindfulness Quality of life Transplantation Renal disease |
Additional relevant MeSH terms:
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |