Wellness Interventions After Transplant Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Mind-Body Interventions Post Organ Transplant

Conditions
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Organ Transplant

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction (MSBR)
* Behavioral: Health Education (HE)
* Behavioral: Delayed Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung recipients, with a functioning graft 18 years old or older English-speaking literate 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Mindfulness-Based Stress Reduction (MSBR)<br>* 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.<br>|
| Active Comparator: 2<br> | Behavioral: Health Education (HE)<br>* 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.<br>|
| No Intervention: 3<br> | Behavioral: Delayed Intervention<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depression |  | Baseline; at 8 weeks, at 6- and 12- months | 
| anxiety |  | Baseline; at 8 weeks, at 6- and 12- months | 
| insomnia |  | Baseline; at 8 weeks, at 6- and 12- months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meditation, Mindfulness, Organ Transplant, Transplantation, Minnesota, Immune suppressive therapy