Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States.
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.
Complement Ther Med. 2020 Dec;55:102610. doi: 10.1016/j.ctim.2020.102610. Epub 2020 Nov 4.
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.
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.
Two large U.S. health systems in Northern California.
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.
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.
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.
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.
越来越多的证据表明正念减压（MBSR）对疼痛相关和功能障碍有效。为了成功有效地进行 MBSR 试验，需要有关于改善招募、保留和依从性的策略相对表现的证据，但很少有研究专门研究这些问题。
为了进行一项充分有力的试验，我们对 60 名偏头痛患者进行了为期 8 周的 MBSR 与常规护理的 2 臂平行比较随机对照可行性试验。
北加利福尼亚的两个大型美国医疗系统。
MBSR 是一种 8 周的课堂式干预措施，结合正念冥想和瑜伽，以及关于压力心理学和团体过程/体验式教育的讲座。参与者可以选择参加现有的、经过审查的社区课程之一来接受干预。
成功招募被定义为在任何 9 周内招募 18 名参与者或在 36 周内招募 60 名参与者。如果参与者参加了 8 周的课程中的至少 5 次和为期一天的静修，我们就认为他们坚持了干预。
我们在 7 周内成功招募了 18 名参与者，但没有达到在 36 周内招募 60 名参与者的第二个目标。我们的参与者中有 68%坚持了干预。
我们发现，密切监测招募活动、灵活调整方案以及将其融入交付系统是正念研究中成功招募、保留和依从性的关键因素。
