Organ Transplant Clinical Trial
Official title:
Impact of Mind-Body Interventions Post Organ Transplant
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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