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RECRUITING
NCT06350877
NA

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

Sponsor: University of Toronto

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2024-01-08

Completion Date

2025-08

Last Updated

2025-01-23

Healthy Volunteers

Yes

Interventions

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 (1)

University of Toronto, Mental Health and Physical Activity Research Centre

Toronto, Ontario, Canada