A Phase 3 interventional study of Mindfulness-Based Stress Reduction (MSBR) and Health Education (HE) in Organ Transplant, sponsored by National Institute of Nursing Research (NINR). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-16.
Sponsored by National Institute of Nursing Research (NINR) · Phase 3 and Interventional
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.
National Institute of Nursing Research (NINR) is the lead sponsor of 48 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Mindfulness-Based Stress Reduction (MSBR)
Behavioral: Health Education (HE)
Behavioral: Delayed Intervention
Mindfulness-Based Stress Reduction (MBSR) is the intervention of primary interest. It is a psycho-educational program of 8-weekly classes, 2.5 hours long taught by a trained instructor. Over the course of the program participants receive training in several formal meditation techniques: a body-scan meditation, sitting meditation, walking meditation and mindful Hatha yoga that involves simple stretches and movements. Participants are requested to practice meditation at home and to integrate informal mindfulness practices into their daily lives. The content of MBSR is described in the book Full Catastrophe Living by Jon Kabat-Zinn.
The active control condition was a peer-led chronic disease self-management program comprised of 8 weekly, 2.5 hour meetings. Led by trained peer-leaders, groups of participants discussed health challenges and problem-solved using a technique called action-planning. The curriculum described by Lorig and colleagues in the book Living a Health Life was the core of this program, and transplant-specific issues were covered in two meetings to match MBSR for time and attention.
A temporary wait-list control group; after 6 months, those in the Delayed Intervention were randomized a second time, to one of the active treatment arms (MBSR or HE).
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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National Institute of Nursing Research (NINR)