Journeys to Wellness: A Transplant Candidate Study
This study is ongoing, but not recruiting participants.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01254214
First received: September 27, 2010
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End-stage Renal Disease |
Behavioral: tMBSR Behavioral: Support group |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- State-Trait Anxiety Inventory [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]self-reported anxiety symptoms
Secondary Outcome Measures:
- Short Form -12 [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]Measure self-perceived mental and physical health status
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]A measure of self-reported sleep quality over the past month
- Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]A self-reported measure of symptoms of depression
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
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
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254214
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Cynthia R Gross, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01254214 History of Changes |
| Other Study ID Numbers: | 0907S70361, 2P01DK013083 |
| Study First Received: | September 27, 2010 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 18, 2013