Online Mindfulness-Based College for Young Adults

NCT04733300 | Unknown

• 1 other identifier: #1608001570
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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; Diet; Sleep; Emotional Regulation; Alcohol Consumption, Youth; Stress, Psychological

Keywords

Emerging adult; Young Adult; Mindfulness; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (8)

• Feasibility of online MBC as measured by participation rates

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Feasibility will be assessed via three measures. One measure of feasibility will be participant recruitment rates. See other primary outcomes for other measures used.

  3 months

• Feasibility of online MBC as measured by retention rates

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates. See other primary outcomes for other measures used.

  3 months

• Feasibility of online MBC as measured by treatment fidelity: Treatment per protocol

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Feasibility will be assessed via three measures. One measure of feasibility will be treatment fidelity (i.e., treatment per protocol), which will be assessed via the percent adherence of instructors to the MBC curriculum guide.

  3 months

• Feasibility of online MBC as measured by treatment fidelity: Receipt of treatment

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Feasibility will be assessed via three measures. One measure of feasibility will be treatment fidelity (i.e., receipt of treatment), which will be assessed by class attendance.

  3 months

• Feasibility of online MBC as measured by treatment fidelity: Enactment of treatment skills

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Feasibility will be assessed via three measures. One measure of feasibility will be treatment fidelity (i.e., enactment of treatment skills), which will be assessed by home practice completion.

  3 months

• Acceptability of online MBC as measured by the Client Satisfaction Questionnaire

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Acceptability will be assessed using three measures. One such measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used.

  3 months

• Acceptability of online MBC as measured by class attendance

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Acceptability will be assessed using three measures. One such measure of acceptability will be class attendance rates (i.e., proportion of eligible participants who complete MBC, missing no more than 3 classes). See other primary outcomes for other measures used.

  3 months

• Acceptability of online MBC as measured by the Net Promoter Score

  The primary aim of the study is to evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). Acceptability will be assessed using three measures. One such measure of acceptability will be via the Net Promoter Score (NPS). NPS scores range from 0 to 10, with higher values indicating higher ratings. The overall NPS for the program is determined by taking the percentage of participants who promoted the program (NPS of 9 or 10) and subtracting the percentage of participants who gave a score of 6 or lower. Neutral scores of 7 and 8 are not included in the calculation of overall NPS. See other primary outcomes for other measures used.

  3 months

Secondary Outcomes (6)

• Impact of online MBC on depressive symptoms

  3 months

• Impact of online MBC on loneliness

  3 months

• Impact of online MBC on sedentary activity

  3 months

• Explore mechanisms (i.e., interoceptive awareness) by which online MBC may influence health outcomes

  3 months

• Explore mechanisms (i.e., decentering) by which online MBC may influence health outcomes

  3 months

Study Arms (3)

Mindfulness-Based College - Standard Dose

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based College for Young Adults

Mindfulness-Based College - Low Dose

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based College for Young Adults

Health education control group

ACTIVE COMPARATOR

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.

Other: Health Education for Young Adults

Interventions

Mindfulness-Based College for Young Adults BEHAVIORAL

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.

Also known as: Mindfulness-Based College standard dose, Mindfulness-Based College low-dose

Mindfulness-Based College - Low Dose; Mindfulness-Based College - Standard Dose

Health Education for Young Adults OTHER

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.

Health education control group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eric Loucks: lead

Study Sites (1)

Mindfulness Center at Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Depression; Sedentary Behavior; Motor Activity; Emotional Regulation; Underage Drinking; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Adolescent Behavior; Alcohol Drinking; Drinking Behavior

Study Officials

• Eric B Loucks, PhD

  Mindfulness Center at Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MB-College Research Study

CONTACT

4014004768; mindfulness@brown.edu

Frances B Saadeh, MPH

CONTACT

4018636261; Frances_Saadeh@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study staff will be blinded to the participant treatment allocation to promote equipoise with the exception of the instructor and staff member coordinating participants within each course. Participants randomized to low vs standard dose MBC will not know which dose they received as all participants are requested to reserve 2.5 hours for the program each week. Participants however will be unmasked about if they received MBC vs. health education due to how different the programs are in content. Data analyses will be performed by a statistician blinded to treatment allocation type. The data manager will be able to break blinding if needed for safety. Circumstances for breaking the blind would be a large number of adverse experiences (\>10% of enrolled participants reporting AEs rated as severe or life threatening) taking place in one or more study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The methodological approach includes a 3-arm trial of MBC (i.e, standard-dose vs. low-dose) vs. health education control, with n=100 per arm (total sample size 300 participants enrolled and randomized).

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: February 2, 2021
• Study Start: October 9, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1.5 years of study completion.
• Access Criteria: Please contact the principal investigator, Eric Loucks, at eric.loucks@brown.edu.

Locations

US (1)