NCT07242378

Brief Summary

The overarching objective of the current study is to evaluate the effectiveness, acceptability, strategy use, and maintenance of behaviour change of different stress management sustainability groups. Furthermore, the study aims to examine how these sustainability groups and maintenance of behaviour change may impact student wellness in the long term. Specifically, objective 1 sought to compare three commonly employed approaches for sustainability of stress management strategy use (workshop booster sessions, online community drop-ins, digital infographic reminders) and an inactive control group (no support) in terms of their (1.1) effectiveness on wellness outcomes (i.e., stress, healthy and unhealthy coping capacity, mindfulness, coping self-efficacy, and well-being), (1.2) acceptability, (1.3) strategy use, and (1.4) maintenance of behaviour change over time. It was hypothesized that the community drop-in sustainability group would have greater effectiveness, strategy use, and maintenance of behaviour change compared to the other sustainability groups and inactive control. This hypothesis aligns with the literature across both sustainability supports and maintenance of behaviour change-related indices, suggesting that social support is a key element to sustained strategy use (Borghouts et al., 2021; Kelders et al., 2012; Kwasnicka et al., 2016). No specific hypothesis was made for which sustainability approach would be rated as most (H1.2) acceptable given this is a novel area of research. Objective 2 sought to examine (2.1) whether maintenance of behaviour change at post (T2) predicted wellness outcomes (i.e., stress, healthy and unhealthy coping capacity, mindfulness, coping self-efficacy, and well-being) at 6-month follow-up (T4), and whether this relationship was differentially moderated by sustainability group. It was hypothesized (H2.1) that maintenance of behaviour change at post would positively predict healthy coping, mindfulness, coping self-efficacy, and well-being and negatively predict stress and unhealthy coping at the 6-month follow-up and that this would be moderated by sustainability group (i.e., workshop booster sessions, online community drop-ins, digital infographic reminders).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

stress managementmaintenance of behaviour changestrategy useself-guided resourceuniversity students

Outcome Measures

Primary Outcomes (1)

  • Change in stress

    The Perceived Stress Scale (PSS) is a widely used self-report measure of individuals' perception of stress. This measure contains 10 items in which participants indicate their experience of stress on a 5-point Likert scale (0 = never to 4 = very often). Items were adapted to reflect experiences during the past week and include statements such as "In the past week, how often have you felt difficulties were piling up so high that you could not overcome them?" Ratings were averaged across items such that higher scores represented greater perceived stress. The PSS has good reliability (Cronbach's α = .89), construct validity, and predictive validity with reports of psychological and physical symptoms.

    baseline, 1-month , 3-month, and 6-month follow-up

Secondary Outcomes (7)

  • Group differences on satisfaction

    1-month , 3-month, and 6-month follow-up

  • Change in coping capacity

    baseline, 1-month , 3-month, and 6-month follow-up

  • Change in mindfulness

    baseline, 1-month , 3-month, and 6-month follow-up

  • Change in coping self-efficacy

    baseline, 1-month , 3-month, and 6-month follow-up

  • Change in well-being

    baseline, 1-month , 3-month, and 6-month follow-up

  • +2 more secondary outcomes

Study Arms (4)

Experimental: Workshop Booster Sessions

EXPERIMENTAL

Two 45-minute online workshop booster sessions presented about two months apart, led by two trained undergraduate peer facilitators with 10 to 20 participants per session. Students were taught strategies to support their use of stress management techniques. Session themes included: (a) understanding values; (b) goal setting; (c) planning for challenges; (d) awareness of resources; (e) facing setbacks; (f) building a community of practice; and (g) general tips for getting started. Following each workshop session, students were emailed a brief one-page resource sheet with links to the strategies for habit formation presented in the session.

Behavioral: Sustainability of stress management strategy useBehavioral: Stress management

Experimental: Community Drop-in Sessions

EXPERIMENTAL

Five monthly 20-minute online community drop-in sessions held over a five-month period, led by the same peer facilitators as in the workshop and with 10-15 participants. These community drop-in sessions covered identical content to that of the workshop sessions, but were delivered in a more informal discussion format (i.e., no PowerPoint presentation). Students were taught strategies to support their use of stress management techniques. Session themes included: (a) understanding values; (b) goal setting; (c) planning for challenges; (d) awareness of resources; (e) facing setbacks; (f) building a community of practice; and (g) general tips for getting started. Following each community drop-in session, students were emailed a brief one-page resource sheet with links to the strategies for habit formation presented in the session.

Behavioral: Sustainability of stress management strategy useBehavioral: Stress management

Experimental: Infographic Reminders

EXPERIMENTAL

Ten brief digital infographic reminders (one to two pages each) emailed to students once every two weeks over a five-month period.The infographics including strategies with interactive links to support their use of stress management techniques. Session themes included: (a) understanding values; (b) goal setting; (c) planning for challenges; (d) awareness of resources; (e) facing setbacks; (f) building a community of practice; and (g) general tips for getting started.

Behavioral: Sustainability of stress management strategy useBehavioral: Stress management

No Sustainability Intervention: Inactive Control

ACTIVE COMPARATOR

Participants in the inactive control group did not receive any sustainability support until the end of the study.

Behavioral: Stress management

Interventions

Then, different sustainability approaches (workshop boosters, community drop-ins, infographic reminders) were developed to ensure equivalent content across: (a) psychoeducation on habit formation and maintenance of behaviour change; and (b) embedded skills-based practice of habit formation. Themes addressed in the sustainability approaches included: (a) understanding values; (b) goal setting; (c) planning for challenges; (d) awareness of resources; (e) facing setbacks; (f) building a community of practice; and (g) general tips for getting started.

Experimental: Community Drop-in SessionsExperimental: Infographic RemindersExperimental: Workshop Booster Sessions

All groups received a digital infographic with interactive links with stress management strategies. Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support.

Experimental: Community Drop-in SessionsExperimental: Infographic RemindersExperimental: Workshop Booster SessionsNo Sustainability Intervention: Inactive Control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 1Y2, Canada

Location

Related Publications (12)

  • Taylor ME, Liu M, Abelson S, Eisenberg D, Lipson SK, Schueller SM. The Reach, Effectiveness, Adoption, Implementation, and Maintenance of Digital Mental Health Interventions for College Students: A Systematic Review. Curr Psychiatry Rep. 2024 Dec;26(12):683-693. doi: 10.1007/s11920-024-01545-w. Epub 2024 Oct 11.

    PMID: 39392547BACKGROUND
  • Saleem M, Kuhne L, De Santis KK, Christianson L, Brand T, Busse H. Understanding Engagement Strategies in Digital Interventions for Mental Health Promotion: Scoping Review. JMIR Ment Health. 2021 Dec 20;8(12):e30000. doi: 10.2196/30000.

    PMID: 34931995BACKGROUND
  • Oey LT, McDonald S, McGrath L, Dear BF, Wootton BM. Guided versus self-guided internet delivered cognitive behavioural therapy for diagnosed anxiety and related disorders: a preliminary meta-analysis. Cogn Behav Ther. 2023 Nov;52(6):654-671. doi: 10.1080/16506073.2023.2250073. Epub 2023 Sep 1.

    PMID: 37655553BACKGROUND
  • Lattie EG, Adkins EC, Winquist N, Stiles-Shields C, Wafford QE, Graham AK. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. J Med Internet Res. 2019 Jul 22;21(7):e12869. doi: 10.2196/12869.

    PMID: 31333198BACKGROUND
  • Heber E, Ebert DD, Lehr D, Cuijpers P, Berking M, Nobis S, Riper H. The Benefit of Web- and Computer-Based Interventions for Stress: A Systematic Review and Meta-Analysis. J Med Internet Res. 2017 Feb 17;19(2):e32. doi: 10.2196/jmir.5774.

    PMID: 28213341BACKGROUND
  • Harrer M, Adam SH, Baumeister H, Cuijpers P, Karyotaki E, Auerbach RP, Kessler RC, Bruffaerts R, Berking M, Ebert DD. Internet interventions for mental health in university students: A systematic review and meta-analysis. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1759. doi: 10.1002/mpr.1759. Epub 2018 Dec 26.

    PMID: 30585363BACKGROUND
  • Fleming T, Bavin L, Lucassen M, Stasiak K, Hopkins S, Merry S. Beyond the Trial: Systematic Review of Real-World Uptake and Engagement With Digital Self-Help Interventions for Depression, Low Mood, or Anxiety. J Med Internet Res. 2018 Jun 6;20(6):e199. doi: 10.2196/jmir.9275.

    PMID: 29875089BACKGROUND
  • Edge D, Watkins ER, Limond J, Mugadza J. The efficacy of self-guided internet and mobile-based interventions for preventing anxiety and depression - A systematic review and meta-analysis. Behav Res Ther. 2023 May;164:104292. doi: 10.1016/j.brat.2023.104292. Epub 2023 Mar 22.

    PMID: 37003138BACKGROUND
  • Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.

    PMID: 16870053BACKGROUND
  • Arnett JJ, Zukauskiene R, Sugimura K. The new life stage of emerging adulthood at ages 18-29 years: implications for mental health. Lancet Psychiatry. 2014 Dec;1(7):569-76. doi: 10.1016/S2215-0366(14)00080-7. Epub 2014 Dec 3.

    PMID: 26361316BACKGROUND
  • Amanvermez Y, Zhao R, Cuijpers P, de Wit LM, Ebert DD, Kessler RC, Bruffaerts R, Karyotaki E. Effects of self-guided stress management interventions in college students: A systematic review and meta-analysis. Internet Interv. 2022 Feb 12;28:100503. doi: 10.1016/j.invent.2022.100503. eCollection 2022 Apr.

    PMID: 35242591BACKGROUND
  • Achilles MR, Anderson M, Li SH, Subotic-Kerry M, Parker B, O'Dea B. Adherence to e-mental health among youth: Considerations for intervention development and research design. Digit Health. 2020 May 21;6:2055207620926064. doi: 10.1177/2055207620926064. eCollection 2020 Jan-Dec.

    PMID: 32547775BACKGROUND

Study Officials

  • Nancy Heath, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished James McGill Professor Emerita

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

September 20, 2023

Primary Completion

April 2, 2024

Study Completion

April 2, 2024

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations