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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Toronto
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Depression
Study Overview
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 (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 physical activity training;
- Group-based physical activity training consisting of small 5-8 person groups; or
- 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.
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 (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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Masking Description
Following completion of the baseline assessment (T1), students will be randomly assigned to an experimental arm or the control arm by a program coordinator for the study. To prevent care provider bias, the physical activity coaches will remain blind to the purpose of group allocation and hypotheses of the study. Research Randomizer (www.randomizer.org) will be used to allocate participants into three equal groups using a blocked design (with an allocation ratio of 1:1:1).
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Godin 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
Outcomes
Primary Outcomes
Depression
Time Frame: T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
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
Anxiety
Time Frame: T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
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.
Psychological distress
Time Frame: T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).
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.
Well-being
Time Frame: T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline)
The Mental Health Inventory-38 will be used to measure the 14-item psychological well-being subscale. Students will be asked to report how often during the past month they experienced symptoms of psychological well-being (e.g., How much of the time, during the past month, did you feel relaxed and free from tension; During the past month, how much of the time have you generally enjoyed the things you do?) on a six-point Likert scale. A total summed score will be used in main analyses, where higher scores represent more positive experiences of well-being.
Secondary Outcomes
- Social Connectedness(T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).)
- Physical Activity Behaviour(T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).)
- Social Support(T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline).)
- Intervention Reach(T2 (42 days from baseline))
- Therapeutic Alliance(T2 (42 days from baseline))
- Intervention Satisfaction(T2 (42 days from baseline))
- Coach Perceptions(T2 (42 days from baseline))
Investigators
Melissa deJonge
Student Principal Investigator
University of Toronto