1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being
NCT06350877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2025-01-23
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.
Conditions
- Physical Activity
- Mental Health Issue
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.
Sponsors & Collaborators
-
University of Toronto
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2025-08-31
- Completion
- 2025-08-31
Countries
- Canada
Study Locations
More Related Trials
-
Tools for Wellbeing COVID-19 National Study of Undergraduate Students
NCT04414371 ·Status: UNKNOWN ·Phase: NA
-
Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students
NCT06348277 ·Status: COMPLETED ·Phase: NA
-
Change in Social Media Use and Well-being Among College Students Receiving a Two-week Exercise or Mindfulness Intervention
NCT07097545 ·Status: RECRUITING ·Phase: NA
-
The Effect of Exercise on Cognition and Preventing Depression in Young People
NCT04816617 ·Status: COMPLETED ·Phase: NA
-
The Effects of Online Single-Session Interventions on College Student Well-being
NCT04287374 ·Status: COMPLETED ·Phase: NA
-
Change in Social Media Use and Well-being Among College Students Receiving a One-week Exercise or Mindfulness Intervention
NCT06143852 ·Status: COMPLETED ·Phase: NA
-
Using an Online Psychotherapy Program and AI-assisted Interventions for Postsecondary Student Mental Health
NCT05754723 ·Status: WITHDRAWN ·Phase: NA
-
The Effects of Yoga on Student Mental Health
NCT04258540 ·Status: COMPLETED ·Phase: NA
-
Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients
NCT06658340 ·Status: COMPLETED ·Phase: NA
-
Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
NCT03769233 ·Status: COMPLETED ·Phase: NA
-
JoyPop Mobile Mental Health App With Youth
NCT06239519 ·Status: RECRUITING ·Phase: NA
-
Evaluating a Primary-Care Group-based Mindfulness Program
NCT03662581 ·Status: TERMINATED ·Phase: NA
-
Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress
NCT06038942 ·Status: COMPLETED ·Phase: NA
-
Pilot RCT to Test Effectiveness of the ACE4 (Activity Challenge- 4 Areas) for Depression and Anxiety
NCT02538549 ·Status: UNKNOWN ·Phase: NA
-
Prosocial Behavior Can Safeguard Mental Health and Foster Emotional Well-being During the COVID-19 Pandemic
NCT04517006 ·Status: COMPLETED ·Phase: NA
-
Effects of a Mindfulness Meditation App on Subjective Well-Being in Undergraduate University Students
NCT03783793 ·Status: COMPLETED ·Phase: NA
-
Well-being Skills for Reentry
NCT06975657 ·Status: RECRUITING ·Phase: NA
-
In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
NCT03067207 ·Status: COMPLETED ·Phase: NA
-
Evaluating an Online Wellness Intervention for Indian College Students
NCT04592588 ·Status: COMPLETED ·Phase: NA
-
Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
NCT04408027 ·Status: UNKNOWN ·Phase: NA
-
Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing
NCT06050681 ·Status: COMPLETED ·Phase: NA
-
Mindfulness-Based College: Stage 1
NCT03124446 ·Status: COMPLETED ·Phase: NA
-
Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury
NCT05608304 ·Status: COMPLETED ·Phase: NA
-
Healthy Student Initiative
NCT02164708 ·Status: COMPLETED ·Phase: NA
-
TU Tough: Mental Toughness Training for College Success
NCT02982070 ·Status: COMPLETED ·Phase: NA