Mindfulness-Based College: Stage 1
Condition: Diet Habit; Physical Activity; Sleep; Loneliness; Emotional Regulation; Alcohol Consumption, Youth; Stress, Psychological
MeSH terms: Stress, Psychological; Alcohol Drinking; Underage Drinking
Study type: Interventional

Summary: 
      Mindfulness interventions are increasingly offered to undergraduate students at universities
      world-wide, however the evidence base is very limited. The objective is to evaluate effects
      of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate
      student health. A superiority randomized controlled trial with parallel groups will be
      performed with 30 participants in each arm. Participants will be randomly assigned to
      Mindfulness-Based College or health education waitlist control. Investigators will be blinded
      to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months.
      The primary outcome is a college health summary score, including seven evidence-based
      determinants of health particularly relevant to college student well-being: body mass index,
      physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and
      loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control
      is associated with the summary score, utilizing generalized linear models. Secondary analyses
      will evaluate which, if any, of the seven determinants of health are driving associations.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness-Based College; Enhanced Usual Care Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MB-College 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 is based on the manualized and standardized Mindfulness-Based Stress Reduction. 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.; Participants in the enhanced usual care control group were spoken with by trained study staff, and as part of the enhanced usual care, were offered a referral to the study's psychiatrist and University counseling resources, if anxiety, depression, or suicidal ideation levels at baseline or follow-up reached clinical levels on the Beck Anxiety Inventory or the Revised Centers for Epidemiologic Studies Depression (CESD-R) scale. Participants in the control group were eligible to take the MB-College program during the following university term.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Overall, a superiority randomized controlled trial with parallel groups will be performed with 30 participants per arm. Participants will be randomly assigned to MB-College or enhanced usual care control.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mindfulness, meditation, emerging adults, young adults, undergraduate students, stress, health