Wellness Interventions After Transplant Study (WIAT)
|ClinicalTrials.gov Identifier: NCT00367809|
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : September 16, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Organ Transplant||Behavioral: Mindfulness-Based Stress Reduction (MSBR) Behavioral: Health Education (HE) Behavioral: Delayed Intervention||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Mind-Body Interventions Post Organ Transplant|
|Study Start Date :||August 2003|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
Behavioral: Mindfulness-Based Stress Reduction (MSBR)
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.
|Active Comparator: 2||
Behavioral: Health Education (HE)
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.
|No Intervention: 3||
Behavioral: Delayed Intervention
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367809
|United States, Minnesota|
|University of Minnesota Academic Health Center|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Dr. Cynthia Gross||University of Minnesota - Clinical and Translational Science Institute|