Mindfulness-Based College: Pilot Randomized Controlled Trial

Mindfulness-Based College: Pilot RCT



Sponsors

Lead Sponsor



Source

Brown University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

Overall Status

Recruiting

Start Date

2016-09-01

Completion Date

2018-05-31

Primary Completion Date

2018-05-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in College Health Summary Score
6 months follow-up vs. baseline

Secondary Outcome

Measure

Time Frame

Change in Self Awareness
6 months follow-up vs. baseline
Change in Attention Control - Sustained Attention to Response Task
6 months follow-up vs. baseline
Change in Attention Control - Mindful Attention Awareness Scale
6 months follow-up vs. baseline

Enrollment

60

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

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.

Arm Group Label

Mindfulness-Based College


Intervention Type

Behavioral

Intervention Name


Description

In the health education wait list control, participants will be offered a 15-30 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.

Arm Group Label

Health education wait list control



Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Years

Maximum Age

28 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Eric B Loucks, PhD
Principal Investigator
Brown University

Overall Contact

Last Name

Eric B Loucks, PhD

Phone

401-863-6283

Email

[email protected]


Location

Facility

Status

Contact

Investigator

Brown University School of Public Health
Providence Rhode Island 02912 United States
Recruiting
Last Name: Eric B Loucks, PhD
Phone: 401-863-6283
Email: [email protected]
Last Name: Eric Loucks, PhD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2017-04-01

Lastchanged Date

2017-04-20

Firstreceived Date

2017-04-14

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Mindfulness-Based College

Arm Group Type

Experimental

Description

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.


Arm Group Label

Health education wait list control

Arm Group Type

Active Comparator

Description

The control condition is a health education wait list control, which participants will be offered a 15-30 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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Frances Saadeh, MPH

Phone

401-863-6361

Email

[email protected]


Acronym

MB-College

Patient Data

Sharing Ipd

Yes

Ipd Description

Personally de-identified data will be made available to researchers with IRB approval.


Firstreceived Results Disposition Date

N/A

Study Design Info

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 health education waitlist control.

Primary Purpose

Prevention

Masking

Investigator, Outcomes Assessor

Masking Description

Investigators will be blinded to treatment allocation, including staff performing assessments, randomization, and data analyses.



ClinicalTrials.gov processed this data on April 28, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2017 ICH GCP