Impact of Mind-Body Interventions Post Organ Transplant
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Reduction in depression
Study Overview
Brief Summary
The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target. This trial is no longer recruiting new patients. Those currently enrolled will be followed for a year to evaluate trial outcomes.
The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction can reduce symptom distress and improve quality of life in solid organ transplant recipients. Primary study outcomes are depression, anxiety and insomnia symptoms, measured by well-validated self-report scales. The impact of this program on objectively measured sleep outcomes, use of health care resources and costs will also be evaluated.
Detailed Description
Pharmacologic options for managing symptoms increase the risks of side effects and drug interactions, and may reduce adherence by complicating an already challenging medication regimen. In contrast, mind-body based complementary therapies may be ideal to treat distressing symptoms and negative emotions after transplantation. Our long-range objective is to develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant recipients, and are safe, practical and cost-effective.
Potential participants are recruited by mail, screening by clinic staff and provider referrals. Interested persons are screened by telephone and mailed informational study brochures. Informed consent is conducted by face-to-face interview, where a diagram of the study design is used to explain the 2-stage randomization and study requirements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung recipients, with a functioning graft
- •18 years old or older
- •English-speaking
- •mentally intact
- •reachable by telephone
- •on immune suppressive medication
- •receiving regular medical follow-up care
- •interested in health promotion and mind-body interventions
- •able to attend weekly classes in a Minnesota Metro area
- •willing to complete the informed consent process
Exclusion Criteria
- •serious preexisting mental health issues such as suicide attempts or a psychosis
- •medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months)
- •on dialysis
- •regularly practicing mindfulness meditation
Outcomes
Primary Outcomes
Reduction in depression
Time Frame: Baseline; at 8 weeks, at 6- and 12- months
anxiety
Time Frame: Baseline; at 8 weeks, at 6- and 12- months
insomnia
Time Frame: Baseline; at 8 weeks, at 6- and 12- months
Secondary Outcomes
No secondary outcomes reported