Mindfulness versus Pharmacotherapy for Chronic Primary Insomnia (MVP #1 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

Other co-Investigators and Collaborators: Melanie Wall (Biostatistics), Jennifer Schultz (health economics), Robert Patterson (bioengineer), Nicole Winbush (family medicine), Michel Cramer-Bornemann and Mark Mahowald (sleep), Louise Anderson and Robin Whitebird (HealthPartners) and Maryanne Reilly-Spong (health psychology).

Funding Source and Amount: University of Minnesota Faculty Development Grant # FRD06-27. Additional support provided by the National Center for Research Resources grant M01 RR00400.

Grant Period: 1/107-12/31/09

Abstract: The negative impact of poor sleep on society and on the quality of our daily lives is widely known. Drs. Gross and Kreitzer received funding to conduct a pilot clinical trial to investigate the potential of MBSR as a treatment for chronic primary insomnia (ClinicalTrials.gov Identifier NCT00515177). 30 adults with primary chronic insomnia were randomized 2:1 to MBSR or an FDA-approved sleep medication - eszopiclone (LUNESTATM). The MBSR treatment consisted of 8 weekly 2.5 hour classes and a daylong retreat, conducted through the Center for Spirituality and Healing. Those randomized to pharmacotherapy were prescribed 3 mg of eszopiclone nightly for 8 weeks, followed by 3 months of use as needed. Measures of sleep were collected pre and post-intervention and at 5 month follow-up. 27 out of 30 patients completed their assigned treatments. Large, significant improvements on sleep scales and sleep diary measures were found after MBSR. From pre to post-intervention, time to fall asleep (sleep onset latency) measured by actigraphy significantly decreased by 8.9 minutes in the MBSR arm. Comparable improvements were found in the eszopliclone group. Half of those in each study group recovered from insomnia, based on standard criteria. This study provides initial evidence for the effectiveness of MBSR as a viable treatment for chronic insomnia as measured by: sleep diary, actigraphy, well-validated sleep scales and measures of remission and clinical recovery. Findings 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): 157.) A manuscript describing these results is currently under review.