Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350877
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-25
Brief Title:
11 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
One-on-one and Group-based Physical Activity Intervention Compared to a Wait-list Control for Post-secondary Student Mental Health and Well-being A 3-arm Parallel Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
None
Brief Summary:
Post-secondary students report alarming rates of feeling overwhelmed hopeless anxious and depressed To better support student mental health there is a well-documented need to improve the range and quality of mental health services available to students Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses
Despite the growing evidence supporting physical activity for student mental health there are significant knowledge gaps in the literature First there is a paucity of research exploring the effects of different delivery styles ie one-on-one 11 vs group on primary ie mental health symptomology including anxiety symptoms depression symptoms psychological distress and secondary ie social support social connectedness outcomes Secondly the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown Lastly limited research has explored contextual implementation factors eg intervention reach adherence and program satisfaction that may influence the sustainability and scale-up of physical activity programs for student mental health Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 11 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health The main questions include
Are there group differences between 11 group-based delivery and waitlist control in the immediate post-intervention and follow-up 1-month maintenance effects on the primary and secondary outcomes
Grounded in recommendations for process evaluation of complex interventions what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination
Trial participants will be randomly assigned to one of the following groups
1 11 physical activity training
2 Group-based physical activity training consisting of small 5-8 person groups or
3 Waitlist control Students will participate in the physical activity intervention after the intervention and follow-up period 10 weeks however their participation will not be monitored or evaluated
The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions Each session involves 1 30-minutes of behaviour change coaching eg goal setting action-planning brainstorming strategies to overcome barriers to engaging in physical activity and 2 30-minutes of supervised and structured physical activity training To address the aims of the study participants will complete self-report questionnaires at baseline post-intervention following completion of the 6-week physical activity intervention and 1-month following completion of the physical activity intervention Questionnaires will assess demographic characteristics primary outcomes ie mental health symptomology including anxiety symptoms depression symptoms psychological distress secondary outcomes ie social support social connectedness physical activity behaviour and contextual implementation factors eg intervention reach adherence and program satisfaction that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination It is hypothesized that there will be no group differences between 11 delivery and group-based delivery on the primary outcomes It is also hypothesized that group-based delivery in comparison to 11 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes Lastly it is hypothesized that in comparison to the control group 11 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes
Despite the growing evidence supporting physical activity for student mental health there are significant knowledge gaps in the literature First there is a paucity of research exploring the effects of different delivery styles ie one-on-one 11 vs group on primary ie mental health symptomology including anxiety symptoms depression symptoms psychological distress and secondary ie social support social connectedness outcomes Secondly the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown Lastly limited research has explored contextual implementation factors eg intervention reach adherence and program satisfaction that may influence the sustainability and scale-up of physical activity programs for student mental health Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 11 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health The main questions include
Are there group differences between 11 group-based delivery and waitlist control in the immediate post-intervention and follow-up 1-month maintenance effects on the primary and secondary outcomes
Grounded in recommendations for process evaluation of complex interventions what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination
Trial participants will be randomly assigned to one of the following groups
1 11 physical activity training
2 Group-based physical activity training consisting of small 5-8 person groups or
3 Waitlist control Students will participate in the physical activity intervention after the intervention and follow-up period 10 weeks however their participation will not be monitored or evaluated
The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions Each session involves 1 30-minutes of behaviour change coaching eg goal setting action-planning brainstorming strategies to overcome barriers to engaging in physical activity and 2 30-minutes of supervised and structured physical activity training To address the aims of the study participants will complete self-report questionnaires at baseline post-intervention following completion of the 6-week physical activity intervention and 1-month following completion of the physical activity intervention Questionnaires will assess demographic characteristics primary outcomes ie mental health symptomology including anxiety symptoms depression symptoms psychological distress secondary outcomes ie social support social connectedness physical activity behaviour and contextual implementation factors eg intervention reach adherence and program satisfaction that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination It is hypothesized that there will be no group differences between 11 delivery and group-based delivery on the primary outcomes It is also hypothesized that group-based delivery in comparison to 11 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes Lastly it is hypothesized that in comparison to the control group 11 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes
Detailed Description:
Introduction
Post-secondary students report alarming rates of feeling overwhelmed hopeless anxious and depressed To better support student mental health there is a well-documented need to improve the range and quality of mental health services available to students Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses
Despite the growing evidence supporting physical activity for student mental health there are significant knowledge gaps in the literature First research to date has predominantly been single-group designs with a lack of a control group and randomization This contributes to limitations in the confidence and quality of the implications drawn from the synthesized studies Indeed within a post-secondary context most studies are noted as poor quality and lack critical information regarding how they are designed delivered and made accessible to students Second there is a paucity of research exploring the effects of different delivery styles ie one-on-one 11 vs group on primary ie mental health symptomology reduction and secondary ie social support social connectedness outcomes Importantly group-based physical activity in comparison to 11 delivered physical activity may provide a less costly and less resource intensive intervention option and may have unique benefits associated with exercising with others and peer-to-peer support eg social support a sense of belonging expanded social networks Third the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown As such conclusions concerning achieving lasting change to mental health and sustained physical activity involvement are not possible Lastly limited research has explored contextual factors eg intervention reach adherence and program satisfaction that may influence the sustainability and scale-up of such programming opportunities Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice
Objectives and Hypotheses
This randomized controlled trial study will assess the immediate post-intervention 6 weeks and follow-up 4 weeks after post-intervention maintenance effects of 11 supervised physical activity and group-based physical activity in comparison to a 10-week waitlist control group in reducing symptoms of poor mental health supporting social well-being outcomes and facilitating physical activity behaviour among post-secondary students experiencing poor mental health The primary outcomes will be the immediate change in symptoms of poor mental health anxiety symptoms depression symptoms psychological distress The secondary outcomes will include follow-up change in symptoms of poor mental health anxiety symptoms depression symptoms psychological distress as well as the immediate and follow-up change in social well-being outcomes social connectedness social support and physical activity behaviour The aims of the study include 1 examining group differences between 11 physical activity delivery group-based physical activity delivery and the 10-week waitlist control group on the primary and secondary outcomes and 2 grounded in process evaluation recommendations to explore contextual factors eg intervention reach adherence and program satisfaction that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination It is hypothesized that there will be no group differences between 11 delivery and group-based delivery on the primary outcomes It is also hypothesized that group-based delivery in comparison to 11 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes Lastly it is hypothesized that in comparison to the control group 11 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes
Study Setting
The trial will be delivered in the post-secondary setting of a large metropolitan university Importantly post-secondary contexts offer natural advantages for large-scale implementation of physical activity programs for student mental health because they offer essential infrastructure eg an integrated setting with access to sport and recreation facilities and mental health services and practical support eg experts in diverse fields to develop evaluate and disseminate sustainable and scalable programs Aligning with this perspective the current study will employ a collaborative implementation approach whereby the research team will work with on-campus sport and recreation professionals ie for the provision of certified coaches with standard training in behavior change coaching and physical activity delivery and mental health professionals in the post-secondary community ie for program design recruitment and implementation and evaluation In addition purposeful efforts eg through advocating for targeted referrals to the program and delivering targeted information sessions will be made to promote the program among professionals eg accessibility services student-life services health and wellness services involved with providing mental health support or referrals to on-campus support services- an important approach for facilitating collaboration across disciplines and sectors in the campus community
Participant Timeline
The university research ethics board REB has approved this study protocol 00045228 Students who meet eligibility and who have provided informed consent will be contacted to schedule an intake session with a program coordinator for the trial Students who do not meet eligibility will be notified via email by the program coordinator and will be provided with a mental health resource sheet outlining alternative health and wellness programs and resources available to participate in Intake sessions will be scheduled in-person in a private research space conveniently located in the campus athletics and recreation centre During the intake session participants will complete the baseline assessment T1 and randomization will be conducted Following completion of the intake session participants in the experimental arms will complete the 6-week physical activity program either 11 physical activity delivery or group-based physical activity delivery In the experimental arms and control condition study outcomes will be assessed at baseline T1 6-weeks post baseline T2 and at 1-month follow-up T3
Sample Size
A 3 group individual control by 3 T1 T2 T3 repeated measures design would require 25 participants per group assuming a moderate effect size of 30 a power level of 80 an alpha of 05 and expected correlations between timepoints of r 50 To account for a loss to follow-up rate of 25 the final targeted sample size is 93 post-secondary students Participants will be randomly assigned to equal groups of approximately 31 students
Recruitment
Purposive and snowball sampling procedures will be used to recruit post-secondary students who are physically inactive and experiencing poor mental health Post-secondary students will be recruited and referred to the intervention through the teams research and professional networks eg health and wellness and student support services student life listservs campus mental health listservs the research teams social media platforms including Twitter and Instagram Digital recruitment materials including email scripts and poster advertisements outlining the purpose of the intervention intervention procedures eligibility criteria and a link to the screening questionnaire will be shared The screening questionnaire will be administered through REDCap and allow participants to sign up up for the intervention through providing their email address and completing several screening questions to confirm eligibility The program coordinator will contact eligible participants through their provided email address to confirm involvement in the study and to schedule an intake meeting
Data Collection Methods
Statistical Methods
Preliminary analyses will include descriptive statistics including mean scores for study variables standard deviations frequency counts for categorical variables and bivariate correlations to examine the relationships between study variables and to describe participant characteristics A 3 group individual control by 3 T1 T2 T3 repeated measures ANOVA will be used to examine whether there are group differences between 11 physical activity delivery group-based physical activity delivery and the 10-week waitlist control group on the primary and secondary outcomes Lastly the implementation process evaluation outcomes will be assessed analyzing the responses to the closed-ended and open-ended questions Closed-ended questions will be analyzed using descriptive statistics and open-ended questions will be analyzed using inductive thematic analysis
Methods Monitoring
Harms
There are minimal risks or harms associated with participating in the research trial Nonetheless the current sample represents a population with relevant group vulnerability due to self-reported mental health concerns There are also inherent risks associated with engaging in physical activity First it is possible that the self-report assessments may provoke negative emotions or may elicit uncomfortable thoughts andor feelings To mitigate emotional risks participants will be informed of their right to not answer questions they feel uncomfortable answering and all participants will be provided with a mental health resource sheet following completion of the intake meeting Participants will also be informed of their right to withdraw from the trial without any penalty to their involvement in the 6-week physical activity intervention Second physical risks are rare but include cardiac events and musculoskeletal injuries To reduce the risk of injury the physical activity sessions will be delivered by certified sport and recreation coaches who have received standard training in behaviour change coaching and physical activity program delivery Participants will also receive clearance for physical activity engagement using the PAR-Q and will be informed to refrain from engaging in any physical activity causing sharp pain nausea dizziness or light-headedness Bi-weekly meetings with the research team and sport and recreation coaches to mitigate any risks or concerns for participant vulnerability throughout the duration of the study will be held
Ethics and Dissemination
Protocol Amendments
Protocol amendments including but not limited to changes in the study objectives the eligibility criteria samples size the outcomes or statistical analyses will be submitted to appropriate REB review Substantive changes will also be documented as amendments to the published study protocol and to the trial registry
Confidentiality
All information collected for this trial will be kept strictly confidential The information will be stored electronically in secure password-protected folders only accessible to members of the research team All data will be collected through a secure online data capture program REDCap where identifying information ie email address participant name will be removed prior to data analysis Data will be coded by participant ID and presented as aggregate-level data to maintain confidentiality and anonymity of the data
Post-secondary students report alarming rates of feeling overwhelmed hopeless anxious and depressed To better support student mental health there is a well-documented need to improve the range and quality of mental health services available to students Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses
Despite the growing evidence supporting physical activity for student mental health there are significant knowledge gaps in the literature First research to date has predominantly been single-group designs with a lack of a control group and randomization This contributes to limitations in the confidence and quality of the implications drawn from the synthesized studies Indeed within a post-secondary context most studies are noted as poor quality and lack critical information regarding how they are designed delivered and made accessible to students Second there is a paucity of research exploring the effects of different delivery styles ie one-on-one 11 vs group on primary ie mental health symptomology reduction and secondary ie social support social connectedness outcomes Importantly group-based physical activity in comparison to 11 delivered physical activity may provide a less costly and less resource intensive intervention option and may have unique benefits associated with exercising with others and peer-to-peer support eg social support a sense of belonging expanded social networks Third the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown As such conclusions concerning achieving lasting change to mental health and sustained physical activity involvement are not possible Lastly limited research has explored contextual factors eg intervention reach adherence and program satisfaction that may influence the sustainability and scale-up of such programming opportunities Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice
Objectives and Hypotheses
This randomized controlled trial study will assess the immediate post-intervention 6 weeks and follow-up 4 weeks after post-intervention maintenance effects of 11 supervised physical activity and group-based physical activity in comparison to a 10-week waitlist control group in reducing symptoms of poor mental health supporting social well-being outcomes and facilitating physical activity behaviour among post-secondary students experiencing poor mental health The primary outcomes will be the immediate change in symptoms of poor mental health anxiety symptoms depression symptoms psychological distress The secondary outcomes will include follow-up change in symptoms of poor mental health anxiety symptoms depression symptoms psychological distress as well as the immediate and follow-up change in social well-being outcomes social connectedness social support and physical activity behaviour The aims of the study include 1 examining group differences between 11 physical activity delivery group-based physical activity delivery and the 10-week waitlist control group on the primary and secondary outcomes and 2 grounded in process evaluation recommendations to explore contextual factors eg intervention reach adherence and program satisfaction that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination It is hypothesized that there will be no group differences between 11 delivery and group-based delivery on the primary outcomes It is also hypothesized that group-based delivery in comparison to 11 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes Lastly it is hypothesized that in comparison to the control group 11 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes
Study Setting
The trial will be delivered in the post-secondary setting of a large metropolitan university Importantly post-secondary contexts offer natural advantages for large-scale implementation of physical activity programs for student mental health because they offer essential infrastructure eg an integrated setting with access to sport and recreation facilities and mental health services and practical support eg experts in diverse fields to develop evaluate and disseminate sustainable and scalable programs Aligning with this perspective the current study will employ a collaborative implementation approach whereby the research team will work with on-campus sport and recreation professionals ie for the provision of certified coaches with standard training in behavior change coaching and physical activity delivery and mental health professionals in the post-secondary community ie for program design recruitment and implementation and evaluation In addition purposeful efforts eg through advocating for targeted referrals to the program and delivering targeted information sessions will be made to promote the program among professionals eg accessibility services student-life services health and wellness services involved with providing mental health support or referrals to on-campus support services- an important approach for facilitating collaboration across disciplines and sectors in the campus community
Participant Timeline
The university research ethics board REB has approved this study protocol 00045228 Students who meet eligibility and who have provided informed consent will be contacted to schedule an intake session with a program coordinator for the trial Students who do not meet eligibility will be notified via email by the program coordinator and will be provided with a mental health resource sheet outlining alternative health and wellness programs and resources available to participate in Intake sessions will be scheduled in-person in a private research space conveniently located in the campus athletics and recreation centre During the intake session participants will complete the baseline assessment T1 and randomization will be conducted Following completion of the intake session participants in the experimental arms will complete the 6-week physical activity program either 11 physical activity delivery or group-based physical activity delivery In the experimental arms and control condition study outcomes will be assessed at baseline T1 6-weeks post baseline T2 and at 1-month follow-up T3
Sample Size
A 3 group individual control by 3 T1 T2 T3 repeated measures design would require 25 participants per group assuming a moderate effect size of 30 a power level of 80 an alpha of 05 and expected correlations between timepoints of r 50 To account for a loss to follow-up rate of 25 the final targeted sample size is 93 post-secondary students Participants will be randomly assigned to equal groups of approximately 31 students
Recruitment
Purposive and snowball sampling procedures will be used to recruit post-secondary students who are physically inactive and experiencing poor mental health Post-secondary students will be recruited and referred to the intervention through the teams research and professional networks eg health and wellness and student support services student life listservs campus mental health listservs the research teams social media platforms including Twitter and Instagram Digital recruitment materials including email scripts and poster advertisements outlining the purpose of the intervention intervention procedures eligibility criteria and a link to the screening questionnaire will be shared The screening questionnaire will be administered through REDCap and allow participants to sign up up for the intervention through providing their email address and completing several screening questions to confirm eligibility The program coordinator will contact eligible participants through their provided email address to confirm involvement in the study and to schedule an intake meeting
Data Collection Methods
Statistical Methods
Preliminary analyses will include descriptive statistics including mean scores for study variables standard deviations frequency counts for categorical variables and bivariate correlations to examine the relationships between study variables and to describe participant characteristics A 3 group individual control by 3 T1 T2 T3 repeated measures ANOVA will be used to examine whether there are group differences between 11 physical activity delivery group-based physical activity delivery and the 10-week waitlist control group on the primary and secondary outcomes Lastly the implementation process evaluation outcomes will be assessed analyzing the responses to the closed-ended and open-ended questions Closed-ended questions will be analyzed using descriptive statistics and open-ended questions will be analyzed using inductive thematic analysis
Methods Monitoring
Harms
There are minimal risks or harms associated with participating in the research trial Nonetheless the current sample represents a population with relevant group vulnerability due to self-reported mental health concerns There are also inherent risks associated with engaging in physical activity First it is possible that the self-report assessments may provoke negative emotions or may elicit uncomfortable thoughts andor feelings To mitigate emotional risks participants will be informed of their right to not answer questions they feel uncomfortable answering and all participants will be provided with a mental health resource sheet following completion of the intake meeting Participants will also be informed of their right to withdraw from the trial without any penalty to their involvement in the 6-week physical activity intervention Second physical risks are rare but include cardiac events and musculoskeletal injuries To reduce the risk of injury the physical activity sessions will be delivered by certified sport and recreation coaches who have received standard training in behaviour change coaching and physical activity program delivery Participants will also receive clearance for physical activity engagement using the PAR-Q and will be informed to refrain from engaging in any physical activity causing sharp pain nausea dizziness or light-headedness Bi-weekly meetings with the research team and sport and recreation coaches to mitigate any risks or concerns for participant vulnerability throughout the duration of the study will be held
Ethics and Dissemination
Protocol Amendments
Protocol amendments including but not limited to changes in the study objectives the eligibility criteria samples size the outcomes or statistical analyses will be submitted to appropriate REB review Substantive changes will also be documented as amendments to the published study protocol and to the trial registry
Confidentiality
All information collected for this trial will be kept strictly confidential The information will be stored electronically in secure password-protected folders only accessible to members of the research team All data will be collected through a secure online data capture program REDCap where identifying information ie email address participant name will be removed prior to data analysis Data will be coded by participant ID and presented as aggregate-level data to maintain confidentiality and anonymity of the data
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