NCT05454592

Brief Summary

The overarching goal of the present study was to evaluate a MHSP-presented versus peer-presented mental health resilience skills-building online video outreach program against a wait-list comparison group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

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

January 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

July 4, 2022

Last Update Submit

May 1, 2025

Conditions

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. In the present study, the PSS had good internal consistency with Cronbach's alphas at T1, T2, and T3 were .86, .82, and .85, respectively.

    Week 1, 6 & 10

Secondary Outcomes (5)

  • Change in Coping Self-efficacy

    Week 1, 6 & 10

  • Change in Social Support

    Week 1, 6 & 10

  • Change in Social Connectedness

    Week 1, 6 & 10

  • Change in Mindfulness

    Week 1, 6 & 10

  • Change in Quality of life

    Week 1, 6 & 10

Study Arms (3)

Peer-presented group

EXPERIMENTAL

The online outreach program focused on four key areas of mental health resilience-building: dealing with stress, decreasing self-criticism, improving self-care and help-seeking behaviours, and enhancing social connections and social support. Using videos, interactive infographics, guided audio recordings, and podcasts, students were provided with clear descriptions of each area of mental health resilience as well as a variety of evidence-based strategies specifically targeting one or more of these areas. A first video was sent to students describing the online program, its overall focus, and how to access the skills-based strategies on the website's interactive resource library. Two subsequent videos then were sent to (a) help students with problem-solving for common challenges to strategy practice, and (b) maintain long-term strategy practice habits. To assess differences in terms of preference for deliverer, this video series was delivered by undergraduate students (i.e., peers).

Behavioral: Stress and Coping Online Outreach Program

Mental health service provider-presented group

EXPERIMENTAL

The program focused on four areas of mental health resilience-building: dealing with stress, decreasing self-criticism, improving self-care and help-seeking behaviours, and enhancing social connections and social support. Using videos, infographics, guided audio recordings, and podcasts, students were provided with clear descriptions of each area of mental health resilience as well as a variety of evidence-based strategies specifically targeting one or more of these areas. A first video was sent to students describing the online program, its overall focus, and how to access the skills-based strategies on the website's interactive resource library. Two subsequent videos were then sent to (a) help students with problem-solving for common challenges to strategy practice, and (b) maintain long-term strategy practice habits. To assess differences in terms of preference for deliverer, this video series was delivered by mental health service providers.

Behavioral: Stress and Coping Online Outreach Program

Wait-list comparison group

NO INTERVENTION

Participants in the wait-list comparison group did not receive any intervention throughout the duration of the study. However, they were asked to fill out the same baseline, post, and follow-up surveys as all other participants.

Interventions

3 videos and a resource library disseminated over the course of 9 weeks.

Mental health service provider-presented groupPeer-presented group

Eligibility Criteria

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

You may qualify if:

  • Participants were eligible for the study if they were between 18- 29 years of age, given the unique stressors associated with the developmental period of emerging adulthood (18-29 years old).
  • Participants were required to have access to the internet (at least weekly) as the study was completed entirely online.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

Related Publications (1)

  • Bastien L, Boke BN, Mettler J, Zito S, Di Genova L, Romano V, Lewis SP, Whitley R, Iyer SN, Heath NL. Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students: Randomized Controlled Trial. JMIR Ment Health. 2022 Jul 22;9(7):e34168. doi: 10.2196/34168.

Study Design

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

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 12, 2022

Study Start

January 3, 2020

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The informed consent forms have been shared through the McGill repository which are open access to all individuals.

Shared Documents
ICF
Time Frame
Available as of September 2021
More information

Locations