NCT06773468

Brief Summary

The present study examined the comparative effectiveness of self-directed (video, infographic) vs. non-self directed (workshop) modalities of online stress management resources and an inactive control condition in terms of their effectiveness and acceptability for university students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

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

January 9, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

January 8, 2025

Last Update Submit

January 17, 2025

Conditions

Keywords

stresscopingdigital interventionself-directedonline 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.

    Week 0, 4, and 7

Secondary Outcomes (5)

  • Change in Satisfaction

    Week 4 and 7

  • Change in coping capacity

    Week 0, 4, and 7

  • Change in mindfulness

    Week 0, 4, and 7

  • Change in coping self-efficacy

    Week 0, 4, and 7

  • Change in well-being

    Week 0, 4, and 7

Study Arms (4)

Workshop

EXPERIMENTAL

30-minute online stress management workshop providing psychoeducation and strategy practice with links to strategies shared at the end

Behavioral: stress management

Video

EXPERIMENTAL

a short 10-minute stress management video providing psychoeducation and strategy practice with links to strategies shared at the end

Behavioral: stress management

Infographic

EXPERIMENTAL

a brief 3-page stress management interactive infographic (i.e., with psychoeducation and embedded links for strategy practice)

Behavioral: stress management

Inactive control

NO INTERVENTION

Waitlist inactive control that will receive all stress management materials at the end of the study

Interventions

These different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of 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.

InfographicVideoWorkshop

Eligibility Criteria

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

You may qualify if:

  • Current university student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, Canada

Location

Related Publications (8)

  • Harith S, Backhaus I, Mohbin N, Ngo HT, Khoo S. Effectiveness of digital mental health interventions for university students: an umbrella review. PeerJ. 2022 Mar 31;10:e13111. doi: 10.7717/peerj.13111. eCollection 2022.

    PMID: 35382010BACKGROUND
  • 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
  • Bourdon JL, Moore AA, Long EC, Kendler KS, Dick DM. The relationship between on-campus service utilization and common mental health concerns in undergraduate college students. Psychol Serv. 2020 Feb;17(1):118-126. doi: 10.1037/ser0000296. Epub 2018 Oct 8.

    PMID: 30299149BACKGROUND
  • LaMontagne LG, Doty JL, Diehl DC, Nesbit TS, Gage NA, Kumbkarni N, Leon SP. Acceptability, usage, and efficacy of mindfulness apps for college student mental health: A systematic review and meta-analysis of RCTs. J Affect Disord. 2024 Dec 15;367:951-971. doi: 10.1016/j.jad.2024.09.014. Epub 2024 Sep 10.

    PMID: 39260578BACKGROUND
  • 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
  • Kern A, Hong V, Song J, Lipson SK, Eisenberg D. Mental health apps in a college setting: openness, usage, and attitudes. Mhealth. 2018 Jun 30;4:20. doi: 10.21037/mhealth.2018.06.01. eCollection 2018.

    PMID: 30050916BACKGROUND
  • Frazier P, Gabriel A, Merians A, Lust K. Understanding stress as an impediment to academic performance. J Am Coll Health. 2019 Aug-Sep;67(6):562-570. doi: 10.1080/07448481.2018.1499649. Epub 2018 Oct 4.

    PMID: 30285563BACKGROUND
  • Metzger IW, Blevins C, Calhoun CD, Ritchwood TD, Gilmore AK, Stewart R, Bountress KE. An examination of the impact of maladaptive coping on the association between stressor type and alcohol use in college. J Am Coll Health. 2017 Nov-Dec;65(8):534-541. doi: 10.1080/07448481.2017.1351445. Epub 2017 Jul 14.

    PMID: 28708021BACKGROUND

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

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

January 9, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Restricted by our ethics board approval.

Locations