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

NCT06350877 | Recruiting

• 1 other identifier: PA RCT
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Mental Health Issue

Keywords

One-on-one physical activity; Group physical activity; Alternative mental health support; Mental health promotion

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• Well-being

  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.

  T1 (0 days from baseline), T2 (42 days from baseline) T3 (72 days from baseline)

Secondary Outcomes (7)

• 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)

Study Arms (3)

1:1 Physical Activity Intervention Delivery

EXPERIMENTAL

The physical activity intervention will be delivered using 1:1 coaching.

Behavioral: Physical Activity Intervention

Group Physical Activity Intervention Delivery

EXPERIMENTAL

The group physical activity intervention will receive the physical activity intervention delivered in small groups of 3-8 students led by a trained sport and recreation coach.

Behavioral: Physical Activity Intervention

10-Week Waitlist Control Group

NO INTERVENTION

Students who are assigned to the 10-week waitlist control condition will be assessed on primary and secondary outcomes at baseline (T1), at 6-weeks (T2) and at 1-month follow-up (T3). At completion of the 1-month follow-up assessment, students in the wait-list control condition will be offered participation in the physical activity intervention; however, their behaviour will not be monitored or evaluated. Participants will have a choice of engaging in 1:1 physical activity intervention delivery or group-based physical activity intervention delivery.

Interventions

Physical Activity Intervention BEHAVIORAL

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.

1:1 Physical Activity Intervention Delivery; Group Physical Activity Intervention Delivery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto, Mental Health and Physical Activity Research Centre

Toronto, Ontario, M5S 2W6, Canada

RECRUITING

Related Publications (38)

• American College Health Association. American College Health Association-National College Health Assessment II: Canadian Consortium Executive Summary Spring 2019. 2019. https://www.cacuss.ca/files/Research/NCHA-II%20SPRING%202019%20CANADIAN%20REFERENCE%20GROUP%20EXECUTIVE%20SUMMARY.pdf

  BACKGROUND

• Andermo S, Hallgren M, Nguyen TT, Jonsson S, Petersen S, Friberg M, Romqvist A, Stubbs B, Elinder LS. School-related physical activity interventions and mental health among children: a systematic review and meta-analysis. Sports Med Open. 2020 Jun 16;6(1):25. doi: 10.1186/s40798-020-00254-x.

  PMID: 32548792 BACKGROUND

• Ashdown-Franks G, deJonge M, Arbour-Nicitopoulos KP, Sabiston CM. Exploring the feasibility and acceptability of a physical activity programme for individuals with serious mental illness: A case study. Qualitative Research in Sport, Exercise, and health. 2022; 14(6): 933-955. doi:10.1080/2159676X.2021.2019098

  BACKGROUND

• Barnett P, Saunders R, Buckman JEJ, Cardoso A, Cirkovic M, Leibowitz J, Main N, Naqvi SA, Singh S, Stott J, Varsani L, Wheatly J, Pilling S. Are students less likely to respond to routinely delivered psychological treatment? A retrospective cohort analysis. Compr Psychiatry. 2022 Nov;119:152348. doi: 10.1016/j.comppsych.2022.152348. Epub 2022 Sep 29.

  PMID: 36191389 BACKGROUND

• Braun V, Clarke, V. Using thematic analysis in psychology. Qualitative research in psychology. 2006; 3(2): 77-101.

  BACKGROUND

• Carter T, Guo B, Turner D, Morres I, Khalil E, Brighton E, Armstrong M, Callaghan P. Preferred intensity exercise for adolescents receiving treatment for depression: a pragmatic randomised controlled trial. BMC Psychiatry. 2015 Oct 14;15:247. doi: 10.1186/s12888-015-0638-z.

  PMID: 26467764 BACKGROUND

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Cornish PA, Berry G, Benton S, Barros-Gomes P, Johnson D, Ginsburg R, Whelan B, Fawcett E, Romano V. Meeting the mental health needs of today's college student: Reinventing services through Stepped Care 2.0. Psychol Serv. 2017 Nov;14(4):428-442. doi: 10.1037/ser0000158.

  PMID: 29120201 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• deJonge ML, Omran J, Faulkner GE, Sabiston CM. University students' and clinicians' beliefs and attitudes towards physical activity for mental health. Mental Health and Physical Activity. 2020; 18. doi: 10.1016/j.mhpa.2019.100316

  BACKGROUND

• deJonge ML., Jain S, Faulkner GE, Sabiston CM. On campus physical activity programming for post-secondary student mental health: Examining effectiveness and acceptability. Mental Health and Physical Activity. 2021; 20. doi: 10.1016/j.mhpa.2021.100391

  BACKGROUND

• Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18.

  PMID: 23597377 BACKGROUND

• Godin G. The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The Health and Fitness Journal of Canada. 2011; 4(1): 18-22. doi: 10.4288/hfjc.v4i1.82

  BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.

  PMID: 20123251 BACKGROUND

• Jeftic I, Furzer BJ, Dimmock JA, Wright K, Boyd C, Budden T, Rosenberg M, Kramer B, Buist B, Fitzpatrick I, Sabiston C, de Jonge M, Jackson B. Structured exercise programs for higher education students experiencing mental health challenges: background, significance, and implementation. Front Public Health. 2023 Apr 25;11:1104918. doi: 10.3389/fpubh.2023.1104918. eCollection 2023.

  PMID: 37181716 BACKGROUND

• Jeftic I, Furzer B, Dimmock JA, Wright K, Budden T, Boyd C, Simpson A, Rosenberg M, Sabiston CM, deJonge M, Jackson B. The Stride program: Feasibility and pre-to-post program change of an exercise service for university students experiencing mental distress. Psychol Sport Exerc. 2023 Nov;69:102507. doi: 10.1016/j.psychsport.2023.102507. Epub 2023 Aug 16.

  PMID: 37665942 BACKGROUND

• Jetten J, Haslam C, von Hippel C, Bentley SV, Cruwys T, Steffens NK, Haslam SA. "Let's get physical" - or social: The role of physical activity versus social group memberships in predicting depression and anxiety over time. J Affect Disord. 2022 Jun 1;306:55-61. doi: 10.1016/j.jad.2022.03.027. Epub 2022 Mar 14.

  PMID: 35301039 BACKGROUND

• Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.

  PMID: 12214795 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Litwiller F, White C, Hamilton-Hinch B, Gilbert R. The impacts of recreation programs on the mental health of postsecondary students in North America: An integrative review. Leisure Sciences. 2021; 44(1). doi: 10.1080/01490400.2018.1483851

  BACKGROUND

• Lee RM, Robbins SB. Measuring belongingness: The Social Connectedness and the Social Assurance scales. Journal of Counseling Psychology. 1995; 42(2):232-241. doi: 10.1037/0022-0167.42.2.232

  BACKGROUND

• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

  PMID: 25791983 BACKGROUND

• Muir IL., Munroe-Chandler KJ, Loughead TM, Sutherland CA, & Hawksley KG.The uworkitout uwin program: Improving university students' psychological distress through physical activity. International Journal of Kinesiology and Sports Science. 2020; 8(3). doi: 10.7575/AIAC.IJKSS.V.8N.3P.36

  BACKGROUND

• Nesbitt AE, Collins KJ, Nalder E, Sabiston CM. Occupational Outcomes of a Physical Activity Intervention for Post-Secondary Student Mental Health. Can J Occup Ther. 2021 Sep;88(3):254-265. doi: 10.1177/00084174211021708. Epub 2021 Jun 16.

  PMID: 34132119 BACKGROUND

• Okanagan Charter. Okanagan Charter: An International Charter for Health Promoting Universities & Colleges. 2015. https://wellbeing.ubc.ca/okanagan-charter

  BACKGROUND

• Orpana HM, Lang JJ, Yurkowski K. Validation of a brief version of the Social Provisions Scale using Canadian national survey data. Health Promot Chronic Dis Prev Can. 2019 Dec;39(12):323-332. doi: 10.24095/hpcdp.39.12.02.

  PMID: 31825785 BACKGROUND

• Pascoe M, Bailey AP, Craike M, Carter T, Patten R, Stepto N, Parker A. Physical activity and exercise in youth mental health promotion: a scoping review. BMJ Open Sport Exerc Med. 2020 Jan 23;6(1):e000677. doi: 10.1136/bmjsem-2019-000677. eCollection 2020.

  PMID: 32095272 BACKGROUND

• Rebar AL, Stanton R, Geard D, Short C, Duncan MJ, Vandelanotte C. A meta-meta-analysis of the effect of physical activity on depression and anxiety in non-clinical adult populations. Health Psychol Rev. 2015;9(3):366-78. doi: 10.1080/17437199.2015.1022901. Epub 2015 Jul 3.

  PMID: 25739893 BACKGROUND

• Sampson K, Priestley M, Dodd AL, Broglia E, Wykes T, Robotham D, Tyrrell K, Ortega Vega M, Byrom NC. Key questions: research priorities for student mental health. BJPsych Open. 2022 May 10;8(3):e90. doi: 10.1192/bjo.2022.61.

  PMID: 35535504 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

  PMID: 20335313 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Stubbs B, Vancampfort D, Rosenbaum S, Ward PB, Richards J, Soundy A, Veronese N, Solmi M, Schuch FB. Dropout from exercise randomized controlled trials among people with depression: A meta-analysis and meta regression. J Affect Disord. 2016 Jan 15;190:457-466. doi: 10.1016/j.jad.2015.10.019. Epub 2015 Oct 29.

  PMID: 26551405 BACKGROUND

• Stubbs B, Vancampfort D, Hallgren M, Firth J, Veronese N, Solmi M, Brand S, Cordes J, Malchow B, Gerber M, Schmitt A, Correll CU, De Hert M, Gaughran F, Schneider F, Kinnafick F, Falkai P, Moller HJ, Kahl KG. EPA guidance on physical activity as a treatment for severe mental illness: a meta-review of the evidence and Position Statement from the European Psychiatric Association (EPA), supported by the International Organization of Physical Therapists in Mental Health (IOPTMH). Eur Psychiatry. 2018 Oct;54:124-144. doi: 10.1016/j.eurpsy.2018.07.004.

  PMID: 30257806 BACKGROUND

• Teychenne M, White RL, Richards J, Schuch FB, Rosenbaum S, Bennie JA. Do we need physical activity guidelines for mental health: What does the evidence tell us? Mental Health and Physical Activity. 202; 18: 100315. doi: 10.1016/j.mhpa.2019.100315

  BACKGROUND

• Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment. 1989; 1(3): 207-210. doi: 10.1037/1040-3590.1.3.207

  BACKGROUND

• Warburton DER, Jamnik VK, Bredin SSD, Gledhill N. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health and Fitness Journal of Canada. 2011; 4(2): 3-17.

  BACKGROUND

• deJonge ML, Yuen S, Simard L, Sabiston CM. One-on-one and group-based physical activity intervention compared to a waitlist control for post-secondary student mental health and social well-being: A 3-arm parallel randomized controlled trial protocol. PLoS One. 2025 Aug 29;20(8):e0330851. doi: 10.1371/journal.pone.0330851. eCollection 2025.

  PMID: 40880346 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student Principal Investigator

Model Details: A 3-arm parallel Randomized Controlled Trial (RCT) assessing the immediate (post-intervention) and short-term (1-month) impact of the experimental arms (1:1 physical activity delivery and group-based physical activity delivery) compared to a 10-week control arm (wait-list control) will be conducted. A parallel arm design will be implemented, whereby participants will be randomized to a study arm and each study arm will be allocated a different intervention. The protocol adheres to CONSORT guidelines and SPIRIT recommendations for reporting of clinical trial protocols.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 8, 2024
• Study Start: January 8, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)