Wellness Interventions after Transplant (WIAT trial)

Principal Investigator: Cynthia Gross, Professor, College of Pharmacy, University of Minnesota
 

Co-Principal Investigator: Mary Jo Kreitzer, PhD, RN, FAAN, Director, Center for Spirituality & Healing

Funding Source and Amount: NIH NINR 008585; $2,229,023 (total costs); additional support from National Center for Research Resources grant M01 RR00400

Grant Period: 8/1/03-4/30/08, extended through 4/30/09

Abstract: Transplant recipients experience a myriad of complex symptoms related to their underlying disease and to lifelong immuno-suppression. Drs. Gross and Kreitzer have just completed a five-year, NIH-funded clinical trial to assess the efficacy of Mindfulness-Based Stress Reduction (MBSR) in reducing symptoms of anxiety, depression, and poor sleep and improving quality of life in these patients. (ClinTrials.gov Identifier: NCT00367809) 150 recipients of kidney, kidney/pancreas, liver, heart or lung transplants were randomized to MBSR, a mindfulness meditation training program consisting of eight weekly 2.5 hour classes; Health Education (a peer-led active control) or to a delayed-intervention control group. Symptoms were measured pre- and post-intervention (8 weeks) and at six months and one year follow-ups.  Results showed that the benefits of MBSR were above and beyond those afforded by Health Education. MBSR reduced anxiety and sleep symptoms with significant treatment effects compared to Health Education. Anxiety, depression and sleep symptoms decreased and quality of life measures improved by eight weeks in the MBSR group, and benefits were retained at one year. Comparisons to the delayed intervention group confirmed the impact of MBSR on both symptoms and quality of life. Health Education provided fewer and less durable benefits. Results of this trial suggest that clinicians can safely recommend MBSR to transplant recipients. Outcomes of this trial were presented by Dr. Gross at the 2009 North American Research Conference on Complementary and Integrative Medicine, May 12-15, 2009, Minneapolis, MN. (Published abstract:  Explore: The Journal of Science and Healing, 5(3): 156.) A manuscript detailing these results is currently under review. 

Several methodology papers have been published from this study:
Gross C, Kreitzer MJ, Reilly-Spong M, Winbush N, Schomaker EK, Thomas W Mindfulness meditation training to reduce symptom distress in transplant patients: Rationale, design and experience with a recycled waitlist. Clinical Trials, 6: 76-89, 2009.  
Kreitzer MJ, Gross CR, Reilly-Spong M, Walekchaloet O, Bird C. The Serenity Scale: A Factor Analysis of a Dimension of Spirituality and Well-Being. Journal of Holistic Nursing, 27(1): 7-16, 2009.