Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine.
Study Goal
The researchers aimed to evaluate strategies for improving recruitment, retention, and adherence in a feasibility trial of Mindfulness-Based Stress Reduction (MBSR) for patients with migraine headache.
Results Summary
The study successfully enrolled 18 participants within 7 weeks but did not meet the secondary recruitment goal of 60 participants within 36 weeks. Adherence to the intervention was 68%, with close monitoring and protocol flexibility identified as key factors for success.
Population
60 patients with migraine headache from two large U.S. health systems in Northern California.
Effective Dosage
8 weekly classes plus a day-long retreat (attendance of at least 5 classes and the retreat defined as adherent).
Duration
8 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-Based Stress Reduction (MBSR) | increase | pain-related and functional disorders | - | - | demonstrates effectiveness | #1 |
Mindfulness-Based Stress Reduction (MBSR) | increase | participants | patients with migraine headache | 18 participants within a 7-week period | successfully enrolled | #2 |
Mindfulness-Based Stress Reduction (MBSR) | no change | participants | patients with migraine headache | 60 participants within a 36-week period | did not attain | #3 |
Mindfulness-Based Stress Reduction (MBSR) | increase | participants | patients with migraine headache | 68% | were adherent | #4 |
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.