Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03124446
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2017-04-14
Brief Title:
Mindfulness-Based College Stage 1
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Mindfulness-Based College Stage 1 Randomized Controlled Trial for Emerging Adult Well-Being
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB-College
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 activities6 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-up8 We developed the moderate intensity Mindfulness-Based College MB-College intervention which in a prepost 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 ClinicalTrialsgov
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 eg 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 eg via validated Multidimensional Assessment of Interoceptive Awareness and attention control eg 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 wwwrandomizerorg Variables used to create strata include gender and raceethnicity 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
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 activities6 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-up8 We developed the moderate intensity Mindfulness-Based College MB-College intervention which in a prepost 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 ClinicalTrialsgov
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 eg 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 eg via validated Multidimensional Assessment of Interoceptive Awareness and attention control eg 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 wwwrandomizerorg Variables used to create strata include gender and raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None