StressNCT05454592
Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students
A study testing Stress and Coping Online Outreach Program in people with Stress and Self Efficacy, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Self Efficacy, Social Support
- What is being tested?
- Stress and Coping Online Outreach Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2020to 8 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students: Randomized Controlled Trial
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.
Read the detailed description
Participants were recruited using a study flyer distributed to students in-person on campus and online through email listservs, social media platforms, and from an existing database of university students who participated in previous studies and agreed to be followed-up with. Given the self-paced nature of the program, a staggered recruitment approach was used wherein new participants completed the online baseline questionnaires between January 2020 until early March 2020.
Participants were randomly assigned to one of the three groups (MHSP-presented, peer-presented, or a wait-list comparison group), while counterbalancing the three groups based on gender and preference for seeking help from MHSPs or peers (i.e., using results from the General Help-seeking Questionnaire). Two weeks after the baseline questionnaire was sent, participants in the intervention groups received either the MHSP-presented video or the peer-presented video (video 1) depending on which group they were randomly assigned to, as well as a link for access to the resource library. The following two videos were sent two weeks apart. Participants were encouraged to access the resource library over the duration of the program and were reminded with each video link sent. All participants then received post (T2) and follow-up measures (T3) 6 and 10 weeks following the baseline completion respectively. Participants in the wait-list comparison group were only asked to complete evaluation measures at the three time points (they only received the videos and resource library at the end of the study). Following completion of the study, students received an e-mail with a personalized profile indicating their individual scores on various measures and all participants received full access to the program resources (videos and resource library).
- Conditions
- Stress, Self Efficacy, Social Support, Social Connectedness, Mindfulness, Quality of Life
- Being tested
- Stress and Coping Online Outreach Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress and Coping Online Outreach ProgramBehavioural
3 videos and a resource library disseminated over the course of 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 6 & 10
Secondary outcomes (5)
Change in Coping Self-efficacy
The Coping Self-Efficacy Scale (CSES) is a measure of one's confidence in effectively engaging in coping behaviors in the face of challenges. This measure contains 26 items in which participants indicate confidence in their coping strategies when it comes to handling challenges and stressors on an 11-point Likert scale (0 = cannot do at all to 10 = certain can do). The CSES states "When things aren't going well for you, or when you're having problems how confident or certain are you that you can do the following:" and include statements such as "find solutions to your most difficult problems" and "see things from the other person's point of view during a heated argument." Higher scores on the CSES represent higher coping-self efficacy. The CSES has good internal consistency (Cronbach's α = .91), and test-retest reliability. In the present study, the CSES had good internal consistency, with Cronbach's alphas at T1, T2, and T3 being .92, .93, and .94, respectively.
Measured: Week 1, 6 & 10
Change in Social Support
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report questionnaire developed to assess the subjective perception of social support adequacy from family, friends, and significant others. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Sample items include "There is a special person who is around when I am in need" and "My family really tries to help me." Higher scores on the MSPSS represent higher perception of social support. The MSPSS has good reliability (Cronbach's alpha ranging from .81 to .98) and has good convergent and construct validity In the present study, the MSPSS has a good internal consistency, with Cronbach's alphas at T1, T2, and T3 of .89, .91, and .92, respectively.
Measured: Week 1, 6 & 10
Change in Social Connectedness
The Social Connectedness Scale Revised (SCS-R) is a 20-item self-report questionnaire that assesses emotional distance of the self from both friends and society, along with maintaining a sense of closeness. Items are rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Sample items include "I feel distant from people" and "I am able to relate to my peers." Higher scores on the SCS-R represent higher perception of social connectedness. The SCS-R has good internal reliability (Cronbach's α = .92) and has good convergent and discriminant validity. In the present study, the SCS-R had good internal consistency, with Cronbach's alphas at T1, T2, and T3 of .90, .89, and .91, respectively.
Measured: Week 1, 6 & 10
Change in Mindfulness
The Mindful Attention Awareness Scale (MAAS) measures individuals' dispositional mindfulness (i.e., general tendency to be mindful) by assessing the frequency of mindful states over time. The MAAS consists of 15 items asking participants to report the frequency with which they have certain experiences on a 6-point scale (1 = almost always to 6 = almost never). Sample items include descriptions of experiences such as, "I find myself preoccupied with the future or the past" and "I find myself doing things without paying attention." Scores for this measure are such that higher scores indicate higher levels of mindfulness. The MAAS has demonstrated strong internal consistency (Cronbach's α = .89), as well as high test-retest reliability, convergent and discriminant validity. In the present study, the MAAS had good internal consistency, with Cronbach's alphas at T1, T2, and T3 of .80, .79, and .91, respectively.
Measured: Week 1, 6 & 10
Change in Quality of life
The World Health Organization's Quality of Life Brief questionnaire is a 26-item measure assessing individuals' perception of their life quality within the following domains: physical health, psychological health, social relationships, and their environment. Participants are asked to rate items related to their experience of their own quality of life such on a 5-point Likert scale (1 = not at all to 5 = extreme amount). Sample items include "To what extent do you feel that physical pain prevents you from doing what you need to do?" and "How satisfied are you with the conditions of your living place?" The WHOQOL-BREF shows decent reliability (Cronbach's α values for physical health, psychological health, social relationships, and environmental health were .65, .77, .52 and .79, respectively) and good internal consistency.
Measured: Week 1, 6 & 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start3 Jan 2020
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Nancy Heath, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454592
- Sponsor's protocol ID
- 19-11-031
- Status last verified
- May 2025
- First submitted
- 4 Jul 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The informed consent forms have been shared through the McGill repository which are open access to all individuals.
Publications
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.
PubMed 35762935
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05454592
- Acronym / sponsor ID
- 19-11-031
- Conditions
- Stress, Self Efficacy, Social Support, Social Connectedness, Mindfulness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants were recruited using a study flyer distributed to students in-person on campus and online through email listservs, social media platforms, and from an existing database of university students who participated in previous studies and agreed to be followed-up with. Given the self-paced nature of the program, a staggered recruitment approach was used wherein new participants completed the online baseline questionnaires between January 2020 until early March 2020.
Participants were randomly assigned to one of the three groups (MHSP-presented, peer-presented, or a wait-list comparison group), while counterbalancing the three groups based on gender and preference for seeking help from MHSPs or peers (i.e., using results from the General Help-seeking Questionnaire). Two weeks after the baseline questionnaire was sent, participants in the intervention groups received either the MHSP-presented video or the peer-presented video (video 1) depending on which group they were randomly assigned to, as well as a link for access to the resource library. The following two videos were sent two weeks apart. Participants were encouraged to access the resource library over the duration of the program and were reminded with each video link sent. All participants then received post (T2) and follow-up measures (T3) 6 and 10 weeks following the baseline completion respectively. Participants in the wait-list comparison group were only asked to complete evaluation measures at the three time points (they only received the videos and resource library at the end of the study). Following completion of the study, students received an e-mail with a personalized profile indicating their individual scores on various measures and all participants received full access to the program resources (videos and resource library).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer-presented group | Experimental | Behavioral: Stress and Coping Online Outreach ProgramThe 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). |
| Mental health service provider-presented group | Experimental | Behavioral: Stress and Coping Online Outreach ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress and Coping Online Outreach Program3 videos and a resource library disseminated over the course of 9 weeks. | Behavioural | Mental health service provider-presented group, Peer-presented group |
Primary outcome
Change in Stress
Time frame: Week 1, 6 & 10
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.
5 secondary outcomes
Change in Coping Self-efficacy
Time frame: Week 1, 6 & 10
Change in Social Support
Time frame: Week 1, 6 & 10
Change in Social Connectedness
Time frame: Week 1, 6 & 10
Change in Mindfulness
Time frame: Week 1, 6 & 10
Change in Quality of life
Time frame: Week 1, 6 & 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Derived from this study: PubMed 35762935Bastien 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.
- Individual participant dataSharing planned: Yes. The informed consent forms have been shared through the McGill repository which are open access to all individuals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress and Coping Online Outreach Program in people with Stress and Self Efficacy, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress (time frame: Week 1, 6 & 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.