Physical Activity Clinical Trial
— MBCOfficial title:
Online Mindfulness-Based College for Young Adults (MBC)
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 29 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mindfulness Center at Brown University | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Eric Loucks |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Impact of online MBC on depressive symptoms | Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. the health education active control on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. Depressive symptomatology will be assessed using Center for Epidemiologic Studies Depression Scale Revised (CESD-R). The CESD survey has been used extensively in the epidemiologic literature to assess depressive symptomatology. The scale was updated to the CESD-R by Van Dam et al., which allows diagnosable criteria similar to Diagnostic and Statistical Manual (DSM) of Mental Disorders. Total scores to the CESD-R scale range from 0 to 60, with higher values indicating greater depressive symptomology. | 3 months | |
Secondary | Impact of online MBC on loneliness | Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. the health education active control on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. Loneliness will be assessed using the validated R-UCLA Loneliness Scale. Scores range from 20 to 80 with higher scores indicating greater levels of loneliness. | 3 months | |
Secondary | Impact of online MBC on sedentary activity | Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. the health education active control on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. Sedentary activity will be assessed using the International Physical Activity Questionnaire (IPAQ). The IPAQ allows for two forms of scoring. Results can be reported in categories (e.g., low activity levels, moderate activity levels, or high activity levels with cutoff points being set by current health standards) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. | 3 months | |
Secondary | Explore mechanisms (i.e., interoceptive awareness) by which online MBC may influence health outcomes | Explore mechanisms by which MBC may exert effects on aforementioned health conditions. Interoceptive awareness will be assessed using the validated Multidimensional Assessment of Interoceptive Awareness (MAIA-2). The MAIA-2 reports average scores for eight distinct subscales (i.e., noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting). The mean scores calculated can range from 0 to 5 with higher scores indicating greater levels of interoceptive awareness. An overall mean score of the subscales will be the primary outcome. | 3 months | |
Secondary | Explore mechanisms (i.e., decentering) by which online MBC may influence health outcomes | Explore mechanisms by which MBC may exert effects on aforementioned health conditions. Decentering will be assessed using the validated Experiences Questionnaire (EQ). Scores range from 11 to 55 with higher scores indicating greater levels of decentering, thought to be a positive attribute. | 3 months | |
Secondary | Explore mechanisms (i.e., perceived stress) by which online MBC may influence health outcomes | Explore mechanisms by which MBC may exert effects on aforementioned health conditions. Perceived stress will be measured using the validated 14-item Perceived Stress Scale (PSS-14). Scores range from 0 to 56 with higher scores indicating greater perceived stress. | 3 months |
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