1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350877
• Other study ID #: PA RCT
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., 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 (e.g., 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 1:1 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 1:1, 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. 1:1 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 (e.g., 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 (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., 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 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 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, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes.

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 (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology reduction) and secondary (i.e., social support, social connectedness) outcomes. Importantly, group-based physical activity, in comparison to 1:1 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 (e.g., 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 (e.g., 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 1:1 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 1:1 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 (e.g., 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 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 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, 1:1 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 (e.g., an integrated setting with access to sport and recreation facilities and mental health services) and practical support (e.g., 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 (i.e., 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 (i.e., for program design, recruitment and implementation, and evaluation). In addition, purposeful efforts (e.g., through advocating for targeted referrals to the program and delivering targeted information sessions) will be made to promote the program among professionals (e.g., 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 1:1 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 team's research and professional networks (e.g., health and wellness and student support services; student life listservs; campus mental health listservs; the research team's 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 1:1 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 and/or 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 (i.e., 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• a post-secondary undergraduate or graduate student enrolled either part-time or full-time at a Canadian post-secondary institution

• fluent in English (e.g., proficiency in reading and verbal expression - written and oral)

• able to attend in-person physical activity sessions at the campus athletics and recreation centre

• moderately or insufficiently active ( < 23 units of weekly leisure activity) based on interpretation scores from the Leisure-Time Physical Activity Questionnaire

• experiencing self-reported 'poor', 'fair' or 'good' mental health in the past month.

Exclusion Criteria:

• physically active (24 units or more of weekly leisure activity) based on interpretation scores from the Leisure-Time Physical Activity Questionnaire

• unsuccessful exercise clearance using the physical activity readiness questionnaire (PAR-Q)

• self-reported 'very good' or 'excellent' mental health

Related Conditions & MeSH terms

• Mental Health Issue
• Physical Activity

Intervention

Behavioral:
• Physical Activity Intervention
The physical activity intervention will be a 6-week supervised program. Participation will involve engaging in a weekly 1-h session provided in-person at the campus athletics and recreation centre. Each 1-h session will include: (1) 30 min of behaviour change coaching; and (2) 30 min of supervised and structured physical activity training. The intervention materials will include a behaviour change workbook for facilitating the 30 min of behaviour change coaching. Each week participants will complete the behaviour change workbook in session with the program trainer, whereby the overarching goal is to introduce and reinforce engagement in behaviour change techniques and to facilitate the learning objectives and experiences for each weekly session.

Locations

Country	Name	City	State
Canada	University of Toronto, Mental Health and Physical Activity Research Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	To measure depression symptoms, the Participant Health Questionnaire will be used. The 9-item questionnaire measures the presence and severity of depressive symptoms over the past 2 weeks ranging from 0 (not at all) to 3 (nearly every day). The total summed score ranging from 0-27 will be used in main analyses	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Primary	Anxiety	The Generalized Anxiety Disorder Questionnaire will be used to measure anxiety symptoms. The 7-item questionnaire assesses the frequency of symptoms associated with anxiety during the past two weeks ranging from 0 (not at all) to 3 (nearly every day). The total summed score ranging from 0-27 will be used in main analyses.	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Primary	Psychological distress	Psychological distress will be measured using the 10-item Kessler Psychological Distress Scale. Students will be asked to indicate how often over the last 30 days they experienced symptoms of psychological distress ranging from 1 (none of the time) to 5 (all of the time). The total summed score (ranging from 10 - 50) will be used in analyses, with higher scores reflecting more psychological distress.	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Secondary	Social Support	To measure social support, the 5-item Social Provision Scale will be used. The scale consists of 5-items, on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). A total summed score (ranging from 4 - 16) will be used in main analyses, where higher scores indicate more favorable perceptions of social support.	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Secondary	Social Connectedness	The 8-item Social Connectedness Scale will be used to measure social connectedness. The items portray a general emotional distance between the self and others and reflect behaviour, feelings, or both associated with a lack of connectedness on a 6-point Likert scale ranging from 1 (agree) to 6 (disagree). Scores will be reverse coded, thus higher scores will reflect a more reported sense of social connectedness with a potential range of 8-48.	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Secondary	Physical Activity Behaviour	Physical activity behaviour will be measured using the International Physical Activity Questionnaire-Short Form and reported as the total of a 7-day recall of the duration (in minutes) and frequency (days) of vigorous intensity, moderate intensity, and walking physical activity behavior. A total physical activity score will be computed using a sum of the reported minutes per week of vigorous, moderate, and walking intensity physical activity.	T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
Secondary	Intervention Reach	Intervention reach will be measured by descriptive data including recruitment and referral processes, the percentage of individuals who participate, the percent excluded, completion rates, and characteristics of participants compared with nonparticipants.	T2 (42 days from baseline)
Secondary	Therapeutic Alliance	Therapeutic alliance will be assessed using the 12-item Working Alliance Inventory. The Working Alliance Inventory has predominantly been studied and validated for use in psychotherapeutic contexts. Researchers, however, are increasingly supporting the importance of evaluating the coach-participant relationship for achieving favourable program outcomes. Participants will be asked to respond to each item on a 5-point Likert scale ranging from 1 (never) to 5 (always), wherein a higher score (ranging from 5 - 25) indicates a more positive therapeutic alliance.	T2 (42 days from baseline)
Secondary	Intervention Satisfaction	To assess intervention satisfaction a mix of closed-ended and open-ended questions will be used. The open-ended questions will assess general likes and dislikes towards the program and will be used to corroborate the closed-ended questions to provide an in-depth understanding of intervention satisfaction. Using closed-ended questions, students will be asked to self-report their physical activity session perceptions using 10-items on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating more positive evaluations. Items will be treated as singular continuous variables, and descriptively analyzed.	T2 (42 days from baseline)
Secondary	Coach Perceptions	Participants will be asked to respond to 14-items on a 7-point Likert scale from 1 (Strongly disagree) to 7 (Strongly agree) assessing perceptions of the physical activity coach's ability to integrate core components of the program including providing a supportive environment, taking into account individual needs and preferences, and promoting engagement in enjoyable physical activity options. Higher scores ranging from 14 - 49 will indicate more favourable coach perceptions. Items will be treated as singular continuous variables, and descriptively analyzed.	T2 (42 days from baseline)