Mindfulness-Based College: Pilot RCT

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.

Participants will be recruited using print medium (e.g. recruitment cards and posters
distributed throughout campuses), distributing advertisement graphics via social media, and
advertisement emails sent to student listservs.

The intervention is MB-College, which is an 8-week, 9-session curriculum providing
systematic and intensive training in mindfulness meditation practices, applied to health
behaviors relevant to college students. The curriculum (available upon request) is based on
the manualized and standardized Mindfulness-Based Stress Reduction (MBSR) developed at the
University of Massachusetts Medical School. The course builds a foundation of mindfulness
self-regulation skills, including attention control, self-awareness and emotion regulation.
It then directs those skills towards participants' relationships with health-related factors
particularly salient in college undergraduates, including physical activity, diet, alcohol
consumption, sleep, stress, social relationships, cognitive performance, and emotion
regulation. Health behavior goal setting, and support for behavior change are integrated in
the curriculum.

The control condition is a health education wait list control, which participants will be
offered a 30 minute, one-on-one meeting with the MB-College instructor. There, participants
will learn about the MB-College curriculum, and have opportunities to share their
relationship with common determinants of undergraduate student health and performance,
described above. Together, the student and instructor will explore ways the course may
assist in shifting these parts of their lives, as they see best. A deliberate relationship
will be formed with the instructor.

The primary outcome is a college health summary score, assessed using the following seven
evidence-based determinants of health particularly relevant to college student well-being:
body mass index (height and weight, directly assessed using standard epidemiologic methods);
physical activity (MET minutes and step counts per week, using validated actigraphy and IPAQ
- International Physical Activity Questionnaire); diet (mean daily fruit and vegetable
consumption, utilizing validated Willet food frequency questionnaire); alcohol consumption
(mean drinks per day, via standard questions from Behavioral Risk Factor Surveillance
Survey); sleep quantity (mean sleep hours per night, using Pittsburgh Sleep Quality Index);
perceived stress (validated Perceived Stress Scale score); and loneliness (validated R-UCLA
[University of California Los Angeles] Loneliness Scale score). Specifically, analyses will
assess changes in mean Z-scores of college health summary score, using a single mean health
summary score across the seven aforementioned college health domains. Secondary analyses
will evaluate which of the seven domains are most driving associations. Further primary
analyses will determine if participant-identified health domains to focus on showed
improvements in MB-College vs. control, utilizing the z-score approach described above, but
restricting only to health domains identified by participants as having high readiness to
change.

Secondary outcomes, utilizing the National Institutes of Health (NIH) Science of Behavior
Change Framework and NIH Stage Model for Intervention Development, include measures of
self-regulation hypothesized to be proximal targets to the mindfulness intervention such as
self-awareness (e.g. via validated Multidimensional Assessment of Interoceptive Awareness)
and attention control (e.g. via validated Sustained Attention to Response Task and Mindful
Attention Awareness Scale). Potential effect modifiers assessed include age, race,
ethnicity, and socioeconomic status, as well as adverse childhood experiences utilizing the
Adverse Childhood Experiences Questionnaire.

All in-person assessments will take place at the Brown School of Public Health by trained
research staff experienced in assessing all aforementioned measures. For the estimated
timeline, please see Figure 1.

Stratified randomization will be used for intervention allocation, performed using Research
Randomizer (www.randomizer.org). Variables used to create strata include gender and
race/ethnicity. Blinded, simple random sampling will occur within each strata.

The analytic approach will evaluate whether MB-College vs. control is associated with
college health summary score, described above. Analyses will incorporate generalized linear
models (GLM) with properly chosen link functions, performed using generalized estimating
equations (GEE) with robust standard error estimators. Following "intention-to-treat"
principles, analyses will be conducted on all participants, regardless of intervention
completion.

Focus groups of participants will take place following MB-College, facilitated by Prof.
Abigail Harrison, who is an experienced focus group moderator and researcher. The goal is to
customize MB-College to the unique needs of this population. NVivo software (QSR
International, Burlington, MA) will be utilized to analyze results in collaboration with Dr.
Harrison.

Inclusion Criteria:

- 18-28 years of age, current undergraduate student at any university, and English
communication

Exclusion Criteria:

- current regular meditation practice, substance abuse, suicidal ideation, or history
of bipolar or psychotic disorders or self-injurious behaviors.