Online Mindfulness-Based College for Young Adults (MBC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Feasibility of online MBC as measured by treatment fidelity: Receipt of treatment
研究概览
简要总结
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.
详细描述
Study Design The methodological approach includes a 3-arm trial of MB-College (i.e., standard-dose vs. low-dose) vs. enhanced usual care waitlist control, with n=100 per arm
All research assessments 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. The MBC classes will be offered online via Zoom by a trained and certified MBC instructor.
Baseline assessment links will be sent to all enrolled participants and completed within four weeks of the start of the interventions. A single follow-up survey, "the three month follow up" will occur at least one day after and up to five weeks after the end of the intervention (i.e. the Week 8 class). Staff will prioritize having participants complete the surveys within the first three weeks of the assessment window, but will allow for participants to complete up to five weeks after. Additionally, the study will accept online survey completed outside the official follow up window if needed.
The total length of involvement for study participants will be around 3-4 months from the time of enrollment to the time of the final research assessment. The study interventions last 9 weeks and take place in the first two months for individuals in the standard-dose and low-dose intervention arms.
Participant Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Feasibility of online MBC as measured by treatment fidelity: Receipt of treatment
时间窗: 3 months
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.
Acceptability of online MBC as measured by the Client Satisfaction Questionnaire
时间窗: 3 months
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.
Feasibility of online MBC as measured by retention rates
时间窗: 3 months
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.
Feasibility of online MBC as measured by participation rates
时间窗: 3 months
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.
Feasibility of online MBC as measured by treatment fidelity: Treatment per protocol
时间窗: 3 months
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.
Feasibility of online MBC as measured by treatment fidelity: Enactment of treatment skills
时间窗: 3 months
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.
Acceptability of online MBC as measured by the Net Promoter Score
时间窗: 3 months
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.
Acceptability of online MBC as measured by class attendance
时间窗: 3 months
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.
次要结局
- Impact of online MBC on loneliness(3 months)
- Impact of online MBC on sedentary activity(3 months)
- Impact of online MBC on depressive symptoms(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)
- Explore mechanisms (i.e., perceived stress) by which online MBC may influence health outcomes(3 months)
研究者
Eric Loucks
Associate Professor
Brown University