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Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlistCollege of Pharmacy, University of Minnesota, Minneapolis, Minnesota, United States, School of Nursing, University of Minnesota, Minneapolis, Minnesota, United States, gross002{at}umn.edu
School of Nursing, University of Minnesota, Minneapolis, Minnesota, United States, Center for Spirituality and Healing, University of Minnesota, Minneapolis, Minnesota, United States
College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, United States
Family Medicine and Community Practice, University of Minnesota, Minneapolis, Minnesota, United States
Department of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, United States
Department of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, United States Background Solid organ transplant recipients must take immune suppressive medications that have side effects, cause complications, and lead to distressing symptoms that reduce health-related quality of life (QOL). Mindfulness meditation has been shown to reduce these symptoms in other patient populations, and it is unlikely to interfere with the immune suppressive medication regimen. Purpose This article describes the design and rationale of a clinical trial to determine whether training in mindfulness meditation can reduce depression, anxiety and insomnia after transplantation, and summarizes baseline characteristics of the participants. Methods Transplant recipients were randomized in equal numbers to one of three arms: a Mindfulness-based Stress Reduction (MBSR) program consisting of 8 weeks of group instruction, home practice and telephone monitoring; a time and attention control Health Education program; or a waitlist arm. After serving 6 months as waitlist controls, these participants were re-randomized to MBSR or Health Education. Evaluations were obtained at baseline (prior to the active interventions), 8 weeks, 6 months, and 1 year (after randomization to MBSR or Health Education only). The primary analysis will compare composite symptom scores between MBSR and Health Education, initially or after serving in the waitlist. Subsequent analyses will compare these two groups on depression, anxiety, and insomnia symptom scales and secondary outcomes of health-related QOL, actigraphy, and health care utilization. A separate analysis, using only data collected before re-randomization, will compare short-term outcomes between the waitlist and active treatment arms. Results One hundred fifty recipients were randomized and 72% of waitlist participants (31/43) were recycled to an active intervention after 6 months. Patient characteristics were balanced across trial arms after initial and secondary randomizations. Limitations Transplant recipients are a very select population. Their adherence to the intervention and willingness to serve as waitlist controls prior to re-randomization may be atypical. Participants were not blinded to treatment and primary outcomes are self-reports. Conclusion The innovative design used in the trial enabled the waitlist group to directly contribute to the number in the primary analysis of active arms, and to also serve as an internal validation test. The trial may be a useful model for trials involving very small target populations. Clinical Trials 2009; 6: 76—89. http://ctj.sagepub.com
Clinical Trials, Vol. 6, No. 1,
76-89 (2009) |
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