Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733300
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2020-10-21
Brief Title:
Online Mindfulness-Based College for Young Adults
Sponsor:
Eric Loucks
Organization:
Brown University
Study Overview
Official Title:
Online Mindfulness-Based College for Young Adults MBC
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
MBC
Brief Summary:
MB-College MBC is an 9-week 9 session program ie 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 15 hours in length rather than 25 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
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 15 hours in length rather than 25 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
Detailed Description:
Study Design The methodological approach includes a 3-arm trial of MB-College ie standard-dose vs low-dose vs enhanced usual care waitlist control with n100 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 ie 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
Participants will be recruited to participate in MBC primarily online using the following methods a electronic distribution of the MBC advertisement cards via social media such as Facebook Twitter Instagram etc b emails sent to student listservs and through academic social networksc word of mouth through graduates of the MBC program and university staff interested in supporting the study and d online information sessions offered by course instructor prior to the start of class
Inclusion of women and minority groups - efforts will be made to recruit both women and minority students by intentionally advertising for the study in locations where said populations congregatehave a presence Randomized groups will attempt to be balanced on gender race-ethnicity and level of education
Screening Process Online Screening Those who express interest in the study will complete an online screening assessment and availability form Those who screen eligible based on the anonymous online screening part 1 of 2 will be given the informed consent form online to read over and complete followed by an availability and contact form part 2 of 2
Informed Consent Informed consent will be administered and collected using digital forms through Qualtrics LLC Provo UT USA from interested students who have screened eligible based on the anonymous online screener part 1 or 2 The digital signature and informed consent document will be kept on file in a secure locations separate from participant data
Randomization Process Participants will be randomly assigned to one of three groups 1 the standard-dose MBC group 2 the low-dose MBC group or 3 the health education control group A covariate adaptive randomization process will be used balancing groups based on gender race-ethnicity and level of education
Assessment Overview
The following participant assessments will be administered to study participants
1 Baseline Assessments -online baseline assessment will be completed within the four weeks leading up to the start of the online interventions
2 3-Month Follow Up Assessments - following the end of the nine-week interventions participants will complete online follow up assessments similar to the assessments given at baseline
Measures Descriptions
1 Demographics age raceethnicity socioeconomic status education sexual orientation and gender orientation student status and employment
2 Childhood socioeconomic status retrospective reporting of parents education based on standardized questionnaires used in the Atherosclerosis Risk in Communities ARIC study
3 Treatment expectancy 6-item Credibility Expectancy questionnaire
4 Depressive symptomatology 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
5 Anxiety Assessed using the validated Generalized Anxiety Disorder 7-item GAD-7 scale
6 Adverse Childhood Experiences Measured using the standardized Childhood Trauma Questionnaire CTQ and the Childhood Experiences of Care and Abuse Inventory neglect subscale
7 Medication use Assessed directly from participants medication bottles and self-report using standardized forms including medication name dose frequency of use and reason of use
8 Substance use questions taken from the National College Health Assessment II
9 Alcohol consumption additional self-report standardized questions assessing current alcohol consumption taken from the Behavioral Risk Factor Surveillance Survey BRFSS8
10 Physical Activity Self-report physical activity is assessed using the International Physical Activity Questionnaire IPAQ
11 Fruit and Vegetable Consumption self-report standardized questions assessing current fruit and vegetable consumption taken from Harvard Food Frequency Questionnaire modified to 3-items
12 Sleep Sleep quality and duration is assessed using the validated Pittsburgh Sleep Quality Index PSQI
13 Mindfulness Assessed using the validated Five Facet Mindfulness Questionnaire Short Form 15-items
14 Perceived stress Assessed using the validated 14-item Perceived Stress Scale
15 Interoceptive awareness Assessed using the validated Multidimensional Assessment of Interoceptive Awareness MAIA-2
16 Loneliness Assessed using the validated R-UCLA Loneliness Scale
17 Global Health individual physical mental and social health are measured using the validated NIH PROMIS Global Health v12 scale and PROMIS-292
18 Mindfulness attendance and practice questions will be administered to intervention group participants at the time of the 3 month follow up to get at mindfulness exposure and dose
19 Ecological Momentary Assessment-Stress assessed using 3-item scale developed by Creswell et al 2019
Withdrawal during intervention Some amount of dropout during the study is anticipated and therefore investigators may decide to over enroll in the waitlist group to account for this expected issue If a participant in the intervention group decides to withdraw from the study during the MB-College course they will be invited to still take part in the follow up assessments
Confidentiality Randomly generated participant identification numbers will be assigned to students who consent to data collection All questionnaires and tasks will be completed under the assigned participant identification numbers Consent forms and personal identifiable information will be kept separate and securely away from participant identification numbers in a secure digital file on closed network servers
Blinding All study staff will be blinded to the participant treatment allocation with the exception of the instructor and staff member coordinating participants within each course All staff monitoring participant assessments and survey completion will be blinded to the participant treatment allocation to promote equipoise 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
Acceptability Assessed via acceptability ratings using the validated Client Satisfaction Questionnaire Cronbachs alpha093 class attendance rates proportion of eligible participants who complete MB-College missing no more than 3 classes and the Net Promoter Score
Feasibility Assessed via a participant recruitment rates b participant retention rates and c treatment fidelity assessments via delivery of treatment per protocol assessed via percent adherence of instructors to curriculum guide module receipt of treatment assessed by class attendance and enactment of treatment skills assessed by home practice completion mindfulness levels
Ecological Momentary Assessments
A 3-item customized measure of stress will be administered using time contingent ecological momentary assessments SMS will be administered using Qualtrics SMS service sent to participants personal phones The numbers will be loaded into Qualtrics de-identified using participant ID numbers The SMS messaging will be 1 way with participants completing the survey through a mobile link The survey will be sent at baseline and follow-up assessments every day for 1 week 4 times per day between 1000 am and 1100 pm The survey as well as assessment schedule were tested in a randomized controlled trials n153 and the researchers who conducted the study advised on the implementation for this pilot study
Fidelity Monitoring
Intervention fidelity will be ensured by 1 rigorous program specific training for the instructor with feedback 2 recording of all sessions with a 10 quality audit reviewed with instructor after each cohort 3 monitoring participant attendance home practice of treatment skills and understanding of skills and 4 a comprehensive mixed methods approach eg daily practice logs for understanding of treatment enactment
Follow-up visits Follow-up surveys will be digitally distributed and completed within the pre-defined assessment windows previously outlined Questionnaires and assessments administered at 3-months follow-up are identical to those administered at baseline with the exception that questionnaires for which the answers should not change or be informative age raceethnicity education childhood socioeconomic status are not given at follow-ups In addition adverse events are monitored and documented at each of the follow-up periods as well as throughout the duration of an individuals study involvement
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 ie 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
Participants will be recruited to participate in MBC primarily online using the following methods a electronic distribution of the MBC advertisement cards via social media such as Facebook Twitter Instagram etc b emails sent to student listservs and through academic social networksc word of mouth through graduates of the MBC program and university staff interested in supporting the study and d online information sessions offered by course instructor prior to the start of class
Inclusion of women and minority groups - efforts will be made to recruit both women and minority students by intentionally advertising for the study in locations where said populations congregatehave a presence Randomized groups will attempt to be balanced on gender race-ethnicity and level of education
Screening Process Online Screening Those who express interest in the study will complete an online screening assessment and availability form Those who screen eligible based on the anonymous online screening part 1 of 2 will be given the informed consent form online to read over and complete followed by an availability and contact form part 2 of 2
Informed Consent Informed consent will be administered and collected using digital forms through Qualtrics LLC Provo UT USA from interested students who have screened eligible based on the anonymous online screener part 1 or 2 The digital signature and informed consent document will be kept on file in a secure locations separate from participant data
Randomization Process Participants will be randomly assigned to one of three groups 1 the standard-dose MBC group 2 the low-dose MBC group or 3 the health education control group A covariate adaptive randomization process will be used balancing groups based on gender race-ethnicity and level of education
Assessment Overview
The following participant assessments will be administered to study participants
1 Baseline Assessments -online baseline assessment will be completed within the four weeks leading up to the start of the online interventions
2 3-Month Follow Up Assessments - following the end of the nine-week interventions participants will complete online follow up assessments similar to the assessments given at baseline
Measures Descriptions
1 Demographics age raceethnicity socioeconomic status education sexual orientation and gender orientation student status and employment
2 Childhood socioeconomic status retrospective reporting of parents education based on standardized questionnaires used in the Atherosclerosis Risk in Communities ARIC study
3 Treatment expectancy 6-item Credibility Expectancy questionnaire
4 Depressive symptomatology 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
5 Anxiety Assessed using the validated Generalized Anxiety Disorder 7-item GAD-7 scale
6 Adverse Childhood Experiences Measured using the standardized Childhood Trauma Questionnaire CTQ and the Childhood Experiences of Care and Abuse Inventory neglect subscale
7 Medication use Assessed directly from participants medication bottles and self-report using standardized forms including medication name dose frequency of use and reason of use
8 Substance use questions taken from the National College Health Assessment II
9 Alcohol consumption additional self-report standardized questions assessing current alcohol consumption taken from the Behavioral Risk Factor Surveillance Survey BRFSS8
10 Physical Activity Self-report physical activity is assessed using the International Physical Activity Questionnaire IPAQ
11 Fruit and Vegetable Consumption self-report standardized questions assessing current fruit and vegetable consumption taken from Harvard Food Frequency Questionnaire modified to 3-items
12 Sleep Sleep quality and duration is assessed using the validated Pittsburgh Sleep Quality Index PSQI
13 Mindfulness Assessed using the validated Five Facet Mindfulness Questionnaire Short Form 15-items
14 Perceived stress Assessed using the validated 14-item Perceived Stress Scale
15 Interoceptive awareness Assessed using the validated Multidimensional Assessment of Interoceptive Awareness MAIA-2
16 Loneliness Assessed using the validated R-UCLA Loneliness Scale
17 Global Health individual physical mental and social health are measured using the validated NIH PROMIS Global Health v12 scale and PROMIS-292
18 Mindfulness attendance and practice questions will be administered to intervention group participants at the time of the 3 month follow up to get at mindfulness exposure and dose
19 Ecological Momentary Assessment-Stress assessed using 3-item scale developed by Creswell et al 2019
Withdrawal during intervention Some amount of dropout during the study is anticipated and therefore investigators may decide to over enroll in the waitlist group to account for this expected issue If a participant in the intervention group decides to withdraw from the study during the MB-College course they will be invited to still take part in the follow up assessments
Confidentiality Randomly generated participant identification numbers will be assigned to students who consent to data collection All questionnaires and tasks will be completed under the assigned participant identification numbers Consent forms and personal identifiable information will be kept separate and securely away from participant identification numbers in a secure digital file on closed network servers
Blinding All study staff will be blinded to the participant treatment allocation with the exception of the instructor and staff member coordinating participants within each course All staff monitoring participant assessments and survey completion will be blinded to the participant treatment allocation to promote equipoise 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
Acceptability Assessed via acceptability ratings using the validated Client Satisfaction Questionnaire Cronbachs alpha093 class attendance rates proportion of eligible participants who complete MB-College missing no more than 3 classes and the Net Promoter Score
Feasibility Assessed via a participant recruitment rates b participant retention rates and c treatment fidelity assessments via delivery of treatment per protocol assessed via percent adherence of instructors to curriculum guide module receipt of treatment assessed by class attendance and enactment of treatment skills assessed by home practice completion mindfulness levels
Ecological Momentary Assessments
A 3-item customized measure of stress will be administered using time contingent ecological momentary assessments SMS will be administered using Qualtrics SMS service sent to participants personal phones The numbers will be loaded into Qualtrics de-identified using participant ID numbers The SMS messaging will be 1 way with participants completing the survey through a mobile link The survey will be sent at baseline and follow-up assessments every day for 1 week 4 times per day between 1000 am and 1100 pm The survey as well as assessment schedule were tested in a randomized controlled trials n153 and the researchers who conducted the study advised on the implementation for this pilot study
Fidelity Monitoring
Intervention fidelity will be ensured by 1 rigorous program specific training for the instructor with feedback 2 recording of all sessions with a 10 quality audit reviewed with instructor after each cohort 3 monitoring participant attendance home practice of treatment skills and understanding of skills and 4 a comprehensive mixed methods approach eg daily practice logs for understanding of treatment enactment
Follow-up visits Follow-up surveys will be digitally distributed and completed within the pre-defined assessment windows previously outlined Questionnaires and assessments administered at 3-months follow-up are identical to those administered at baseline with the exception that questionnaires for which the answers should not change or be informative age raceethnicity education childhood socioeconomic status are not given at follow-ups In addition adverse events are monitored and documented at each of the follow-up periods as well as throughout the duration of an individuals study involvement
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