Recruiting

Mindfulness-Based

Sponsor:

Eric Loucks

Code:

NCT04733300

Conditions

Depressive Symptoms

Loneliness

Sedentary Behavior

Mindfulness

Physical Activity

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Interventions

Mindfulness-Based College for Young Adults

Health Education for Young Adults

Study Details

Brief summary:

MB-College (MBC) is an 9-week, 9 session program (i.e., the study intervention being tested in the RCT) providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students and young adults.

The MBC intervention will be administered live, online via the free video conferencing platform, Zoom, to all eligible study participants enrolled in the active arms of the study. In addition to the 9-week, 9 session MBC class, referred to as "standard dose MBC" from here on out, investigators will also be testing a "low-dose MBC" version of the intervention, where each weekly session will run 1.5 hours in length rather than 2.5 hours.

This is a 3-arm randomized controlled trial. The standard-dose and low-dose versions of the MBC intervention will be compared to a third arm of the study, a health education active control group. Members of the control group will be offered the MBC class upon completion of the research study.

The Study Aims are to: (1) Evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). (2) Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. health education control group on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. (3) Explore mechanisms by which MBC may exert effects on aforementioned health conditions, including interoceptive awareness, decentering, and perceived stress.

Participant Population: young adults aged 18-29 years of age, residing in the United States who screen eligible will be invited to enroll. Students will be screened using a two-part process taking place online. Research assessments at baseline and 3-month will take place digitally using Qualtrics, LLC (Provo, UT, USA) survey management tool. Participants will be sent secure links via email that can be accessed with their participant identification number.

Enrolled participants will be randomly assigned to one of three groups: (1) standard MBC; (2) low-dose MBC or (3) health education control group. The control group will be given the opportunity to participate in the intervention after the study MBC course is completed and follow-up assessments have been administered.

Conditions

Depressive Symptoms

Loneliness

Sedentary Behavior

Mindfulness

Physical Activity

Study ID

NCT04733300

Start date

Oct 9, 2020

Status verified date

Jan, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-29 years of age
  • Able to read, write, and speak in English
  • Access to a computer, tablet, or smart phone device in order to complete online assessments and participate in the online interventions
  • Reside in the United States during the research study

Exclusion Criteria:

  • Current, regular mindfulness meditation practice ≥1 time per week
  • Untreated, pre-existing mental health conditions, including borderline disorder, schizophrenia or psychosis, obsessive-compulsive disorder, panic attacks, alcohol or substance abuse, and eating disorders, who are not in regular care of a clinician. These participants are excluded as they may require additional or specialized treatment not able to be provided by the study or are already participating in practices similar to the intervention.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindfulness-Based College - Standard Dose

MBC standard dose is a 9-week, 9 session program providing systematic and intensive training in mindfulness meditation practices. The curriculum is grounded in the manualized and standardized Mindfulness-Based Stress Reduction (MBSR) curriculum. MBSR was adapted to the young adult life stage by: (1) Training mindfulness skills such as attention control, self-awareness and emotion regulation, using the MBSR curriculum, and (2) applying these skills to the health behaviors and priorities most relevant to young adults. Specific behaviors and priorities targeted are social relationships, sleep, stress, diet, physical activity, obesity, alcohol consumption, substance use, digital media use, and performance (e.g. athletic, artistic and academic). The intervention is administered live, online via a video conferencing platform. The standard dose class meets once a week for 2.5 hours for 9 weeks. There is also an all-day retreat that takes place around week 6 of the program.

experimental: Mindfulness-Based College - Low Dose

The MBC low-dose program is mirrored after the standard MBC program (described previously); however, instead of meeting for 2.5 hours each week, the low-dose MBC program is abbreviated to meet for 1.5 hours each week for the 9 weeks. MBC low-dose will be administered live, online via the free video conferencing platform, Zoom.

active comparator: Health education control group

Those randomized to the health education control group will receive young adult-specific online health resources offered through www.youngwomenshealth.org and www.youngmenshealthsite.org. Both websites provide resources to improve mental and physical health, and include opportunities to ask health questions, and learn ways to improve mental and physical well-being.

Interventions

Mindfulness-Based College for Young Adults

MB-College (MBC) is a 9-week, 9 session curriculum providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to young adults (18-29). The curriculum, which is based on the manualized and standardized Mindfulness-Based Stress Reduction (MBSR) curriculum is designed to teach participants how to integrate and apply mindfulness in their everyday lives to the range of challenges arising from medical and psychological conditions and life stresses.

MBC will be administered live, online via a video conferencing platform to participants enrolled in the active arms of the study: (1) standard dose MBC and (2) low-dose MBC. Standard dose MBC meets once a week for 2.5 hours for 9 weeks, while low-dose MBC meets for 1.5 hours per week for 9 weeks. There is an all-day retreat that takes place around week six of the program that applies to both MBC programs.

Health Education for Young Adults

The health education control group will receive young adult-specific online health resources offered through www.youngwomenshealth.org and www.youngmenshealthsite.org. Both websites provide resources to improve mental and physical health, and include opportunities to ask health questions, and learn ways to improve mental and physical well-being.

Primary outcome measure

  • Feasibility of online MBC as measured by participation rates [ Time Frame: 3 months ]
  • Feasibility of online MBC as measured by retention rates [ Time Frame: 3 months ]
  • Feasibility of online MBC as measured by treatment fidelity: Treatment per protocol [ Time Frame: 3 months ]
  • Feasibility of online MBC as measured by treatment fidelity: Receipt of treatment [ Time Frame: 3 months ]
  • Feasibility of online MBC as measured by treatment fidelity: Enactment of treatment skills [ Time Frame: 3 months ]
  • Acceptability of online MBC as measured by the Client Satisfaction Questionnaire [ Time Frame: 3 months ]
  • Acceptability of online MBC as measured by class attendance [ Time Frame: 3 months ]
  • Acceptability of online MBC as measured by the Net Promoter Score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

MB-College Research Study

4014004768mindfulness@brown.edu

Frances B Saadeh, MPH

4018636261Frances_Saadeh@brown.edu

Locations

Mindfulness Center at Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

MB-College Research Study

401-400-4768mindfulness@brown.edu

Principal Investigator:

Eric B Loucks, PhD

More Information

Sponsor

Eric Loucks

Last update posted

Feb 2, 2021

Last verified

Jan, 2021

Keywords

  • Emerging adult
  • Young Adult
  • Mindfulness
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eric Loucks on 2021-02-02.