Heather Law1, Andrew Avins2, Robert Stahl3, Michelle Goodreau1, Alice Jacobson1, Sylvia Sudat1, Alice Pressman4. 1. Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States. 2. Kaiser Permanente Northern California Division of Research, 2000 Broadway, Oakland, CA 94612, United States; University of California San Francisco, Department of Epidemiology and Biostatistics, San Francisco, CA, United States. 3. Insight Santa Cruz a Buddhist Meditation Community, 119 Marnell Avenue, Santa Cruz, CA 95062, United States. 4. Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States; University of California San Francisco, Department of Epidemiology and Biostatistics, San Francisco, CA, United States. Electronic address: pressmar@sutterhealth.org.
Abstract
OBJECTIVES: Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders. In order to conduct successful and efficient trials of MBSR, evidence regarding the relative performance of strategies to improve recruitment, retention, and adherence is required, but few studies have examined these issues specifically. DESIGN: In preparation for a fully powered trial, we conducted a 2-arm, parallel comparison randomized controlled feasibility trial of MBSR vs. usual-care for 60 patients with migraine headache. SETTING:Two large U.S. health systems in Northern California. INTERVENTION: MBSR is an 8-week classroom-based intervention that combines mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education. Participants received the intervention at their choice of one of several existing, vetted community-based classes. MAIN OUTCOME MEASURES: Successful recruitment was defined a priori as 18 participants within any 9-week period or 60 participants enrolled within a 36-week period. We considered participants adherent to the intervention if they attended at least 5 of the 8 weekly classes and the day-long retreat. RESULTS: We successfully enrolled 18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period. Sixty-eight percent of our participants were adherent to the intervention. CONCLUSIONS: We found that close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the delivery system were crucial factors for successful participant recruitment, retention, and adherence in mindfulness research.
RCT Entities:
OBJECTIVES: Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders. In order to conduct successful and efficient trials of MBSR, evidence regarding the relative performance of strategies to improve recruitment, retention, and adherence is required, but few studies have examined these issues specifically. DESIGN: In preparation for a fully powered trial, we conducted a 2-arm, parallel comparison randomized controlled feasibility trial of MBSR vs. usual-care for 60 patients with migraine headache. SETTING: Two large U.S. health systems in Northern California. INTERVENTION: MBSR is an 8-week classroom-based intervention that combines mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education. Participants received the intervention at their choice of one of several existing, vetted community-based classes. MAIN OUTCOME MEASURES: Successful recruitment was defined a priori as 18 participants within any 9-week period or 60 participants enrolled within a 36-week period. We considered participants adherent to the intervention if they attended at least 5 of the 8 weekly classes and the day-long retreat. RESULTS: We successfully enrolled 18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period. Sixty-eight percent of our participants were adherent to the intervention. CONCLUSIONS: We found that close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the delivery system were crucial factors for successful participant recruitment, retention, and adherence in mindfulness research.
Authors: Marcelo E Bigal; Daniel Serrano; Dawn Buse; Ann Scher; Walter F Stewart; Richard B Lipton Journal: Headache Date: 2008-09 Impact factor: 5.887
Authors: James W Carson; Francis J Keefe; Thomas R Lynch; Kimberly M Carson; Veeraindar Goli; Anne Marie Fras; Steven R Thorp Journal: J Holist Nurs Date: 2005-09
Authors: Rebecca Erwin Wells; Suzanne M Bertisch; Catherine Buettner; Russell S Phillips; Ellen P McCarthy Journal: Headache Date: 2011-06-07 Impact factor: 5.887
Authors: Rebecca Erwin Wells; Elizabeth K Seng; Robert R Edwards; David E Victorson; Charles R Pierce; Lauren Rosenberg; Vitaly Napadow; Zev Schuman-Olivier Journal: Expert Rev Neurother Date: 2020-02-12 Impact factor: 4.618
Authors: Daniel C Cherkin; Karen J Sherman; Benjamin H Balderson; Andrea J Cook; Melissa L Anderson; Rene J Hawkes; Kelly E Hansen; Judith A Turner Journal: JAMA Date: 2016 Mar 22-29 Impact factor: 56.272
Authors: Marcelo E Bigal; Michel Ferrari; Stephen D Silberstein; Richard B Lipton; Peter J Goadsby Journal: Headache Date: 2009-02 Impact factor: 5.887
Authors: Alice Pressman; Heather Law; Robert Stahl; Alex Scott; Alice Jacobson; Lisa Dean; Sylvia Sudat; Angelica Obillo; Andrew Avins Journal: Trials Date: 2019-05-06 Impact factor: 2.279