Mindfulness-Based College: Stage 1

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.

Conditions

• Diet Habit
• Physical Activity
• Sleep
• Loneliness
• Emotional Regulation
• Alcohol Consumption, Youth
• Stress, Psychological

Interventions

BEHAVIORAL

Mindfulness-Based College

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.

BEHAVIORAL

Enhanced Usual Care Control

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.

Sponsors & Collaborators

• Brown University

  lead OTHER

Principal Investigators

• Eric B Loucks, PhD · Brown University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

28 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2018-09-09

Completion

2018-09-09

Countries

• United States

Study Locations