Mindfulness-Based College: Stage 1 Randomized Controlled Trial for Emerging Adult Well-Being

1. Background and Rationale

Mindfulness interventions in school- and work-place settings are expanding exponentially, often with a limited evidence base. Increasingly, mindfulness interventions are customized to specific populations and health outcomes to increase intervention efficacy and efficiency. Emerging adulthood and the college undergraduate experience is a sensitive life course period, with strong peer effects, diminished parental influence, and compelling opportunities for exploring health behaviors having sustained effects, including social relationships, sleep patterns, alcohol and substance use, dietary patterns, and physical or sedentary activities.6 Few mindfulness interventions focus specifically on this population, but preliminary results are promising. Specifically, a randomized controlled trial (RCT) evaluating effects of the low time-burden Koru mindfulness intervention showed significant improvements in perceived stress, sleep, mindfulness and self-compassion immediately following the 4-week intervention, vs. waitlist control. An intensive mindfulness intervention RCT, customized to enhance physical activity, nutrition, sleep, mindfulness, compassion, relationships and well-being, demonstrated significant improvements in physical health, working memory, standardized test performance, mood, self-esteem, self-efficacy mindfulness and life satisfaction vs. control, at 6 weeks follow-up.8 We developed the moderate intensity Mindfulness-Based College (MB-College) intervention, which in a pre/post pilot study showed significant improvements in emotion regulation, diastolic blood pressure, stress, mindfulness and cognitive performance at 8 weeks follow-up (Table 1). Overall, early studies suggest potential benefit for college student health, however these studies require replication, longer term follow-up, and rigorous study designs. 2. Objective

The primary objective is to perform an RCT to evaluate effects of MB-College vs. health education waitlist control, on a college undergraduate student health summary score at 6 months follow-up. 3. Methods

Overall, a superiority randomized controlled trial with parallel groups will be performed with 40 participants per arm. Participants will be randomly assigned to MB-College or health education waitlist control. Investigators will be blinded to treatment allocation, including staff performing assessments, randomization, and data analyses. Participants will be assessed at baseline, 10 weeks, and 6 months follow-up. Standard CONSORT guidelines will be followed, including trial registration at ClinicalTrials.gov.

The study population inclusion criteria are 18-28 years of age, current undergraduate student at any university, and English communication. Exclusion criteria follow standard recommendations, specifically current regular meditation practice, substance abuse, suicidal ideation, or history of bipolar or psychotic disorders or self-injurious behaviors.