An Online Intervention Addressing Mental Health and Substance Use in University Students

NCT ID: NCT05606601

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2023-07-21

Brief Summary

The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students.

Detailed Description

There is a need for scalable interventions to support the mental health and substance use challenges experienced by university students. One means of addressing this need is through the use of e-mental health tools that facilitate self-management and connect students to in-person supports as needed. This is a randomized controlled trial of a mobile app designed to help university students manage their mental health and substance use via a set of evidence-based tools that have been integrated into a single mobile app. The recruitment of approximately 1500 students will occur through social media, promotion by faculty members and administrators, and other in-person recruitment methods. Assessments will be conducted using self-report web surveys at baseline, 14 days (interim assessment) and 30 days (follow-up assessment). The goal of the trial is to assess the effectiveness of the app in improving a range of mental health and substance use outcomes of university students from baseline to follow-up.

Conditions

Anxiety; Depression; Alcohol Use; Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

Participants randomized into the intervention arm will be given immediate access to a fully functional version of the Minder app that includes baseline, interim and follow-up surveys and access to all app components and e-coaching.

Group Type: EXPERIMENTAL

Minder

Intervention Type: BEHAVIORAL

There are four main components of the Minder app: The Chatbot, Services, Community, and Peer Coaching components. The Services component asks participants to complete a series of questions on various mental health, substance use, and general life issues. It then recommends community and on-campus resources based on their current needs. The Community component of the app matches individuals with groups (e.g., student clubs) and events at the university or in the broader community that they may be interested in. The Chatbot component of the app contains pre-formatted conversational scripts that users engage with via a "chatbot" and videos designed to teach evidence-based skills (e.g., cognitive strategies to manage anxiety) that can be applied to everyday life. To support use of the app, all users in the intervention group will be offered access to trained peer coaches to help users navigate the different app components and provide non-clinical peer support.

Control arm

Participants randomized into the control arm will be given access to a restricted version of the app that only includes access to a generic study introduction video and baseline and follow up survey assessments delivered via the app.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minder

There are four main components of the Minder app: The Chatbot, Services, Community, and Peer Coaching components. The Services component asks participants to complete a series of questions on various mental health, substance use, and general life issues. It then recommends community and on-campus resources based on their current needs. The Community component of the app matches individuals with groups (e.g., student clubs) and events at the university or in the broader community that they may be interested in. The Chatbot component of the app contains pre-formatted conversational scripts that users engage with via a "chatbot" and videos designed to teach evidence-based skills (e.g., cognitive strategies to manage anxiety) that can be applied to everyday life. To support use of the app, all users in the intervention group will be offered access to trained peer coaches to help users navigate the different app components and provide non-clinical peer support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Must be currently enrolled at participating university

2. Must be 17 years or older

3. Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data

4. Must be English speaking

Exclusion Criteria

1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Vigo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel V Vigo, MD, Lic. Psych, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

Y Wang A, Vereschagin M, G Richardson C, J Munthali R, Xie H, L Hudec K, Mori T, Munro L, V Vigo D. Examining the effects of engagement with an app-based mental health intervention: a secondary analysis of a randomized control trial with treatment non-compliance. Int J Ment Health Syst. 2025 Oct 9;19(1):30. doi: 10.1186/s13033-025-00688-4.

Reference Type: DERIVED

PMID: 41068963 (View on PubMed)

Vereschagin M, Wang AY, Richardson CG, Xie H, Munthali RJ, Hudec KL, Leung C, Wojcik KD, Munro L, Halli P, Kessler RC, Vigo DV. Effectiveness of the Minder Mobile Mental Health and Substance Use Intervention for University Students: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 27;26:e54287. doi: 10.2196/54287.

Reference Type: DERIVED

PMID: 38536225 (View on PubMed)

Wang AY, Vereschagin M, Richardson CG, Xie H, Hudec KL, Munthali RJ, Munro L, Leung C, Kessler RC, Vigo DV. Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Aug 30;12:e49364. doi: 10.2196/49364.

Reference Type: DERIVED

PMID: 37647105 (View on PubMed)

Other Identifiers

H21-03248

Identifier Type: -

Identifier Source: org_study_id