Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- State-Trait Anxiety Inventory
Study Overview
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 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.
Detailed Description
Primary Aims
- 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-weeks and by 6-month follow-up.
- Evaluate the impact of tMBSR on sleep measured by actigraphy, and on physiologic stress, as indicated by alteration in the slope of diurnal salivary cortisols, measured before and at the end of the 8-week active intervention period.
Secondary Aims
- Evaluate the impact of tMBSR on perceptions of transplant surgery (treatment satisfaction, pain) and of Health Related Quality of Life (HRQL) at 2-, 6- and 12-mos post-transplant surgery.
- Design a full-scale randomized controlled trial (RCT) of the effectiveness and cost-effectiveness of tMBSR.
Hypotheses
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: tMBSR (Behavioral)
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
Intervention: Support group (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Short Form -12 MCS(baseline, 8 and 26 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, 8 weeks, 26 weeks)
- Center for Epidemiologic Studies Depression Scale (CESD)(baseline, 8 weeks, 26 weeks)
- SF-12 PCS(baseline, 8 weeks, 26 weeks)