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

NCT05606601 | Completed

• 1 other identifier: H21-03248
• Study Type: interventional
• Target: 1,489
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Alcohol Use; Substance Use

Keywords

Student Mental Health; Anxiety; Depression; Alcohol Use; Substance Use; Cannabis Use; Opioid Use; Stimulant Use; Online Intervention; E-mental Health

Outcome Measures

Primary Outcomes (3)

• Change in General anxiety symptomology from Baseline to Follow-up at 30 days

  Assessed by the General Anxiety Disorder 7-Item (GAD-7) scale. Changes in anxiety symptomology from baseline to follow-up at 30 days will be based on total scores on the GAD-7 in both the intervention and control groups. Total scores range from 0 to 21 with higher scores indicating a worse outcome (i.e, a greater frequency of anxiety symptoms).

  The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.

• Change in Depressive symptomology from Baseline to Follow-up at 30 days

  Assessed by the Patient Health Questionnaire 9-item (PHQ-9) scale. Changes in depressive symptomology from baseline to follow-up at 30 days will be based on total scores on the PHQ-9 in both the intervention and control groups. Total scores range from 0 to 29 with higher scores indicating a worse outcome (i.e., a greater frequency of depression symptoms).

  The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.

• Change in Alcohol consumption risk from Baseline to Follow-up at 30 days

  Assessed by the alcohol consumption questions of the Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT-C). Changes in alcohol consumption risk from baseline to follow-up at 30 days will be based on total scores on the USAUDIT-C in both the intervention and control groups. Total scores range from 0 to 18 with higher scores indicating a worse outcome (i.e., a higher level of risky drinking).

  The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.

Secondary Outcomes (10)

• Frequency of cannabis consumption

  Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.

• Frequency of binge drinking

  Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.

• Frequency of alcohol use

  Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.

• Frequency of opioid use

  Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.

• Frequency of non-medical stimulant use

  Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Minder

Control arm

NO INTERVENTION

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.

Interventions

Minder 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.

Intervention arm

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be currently enrolled at participating university
• Must be 17 years or older
• Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
• Must be English speaking

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (3)

• 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.

  PMID: 41068963 DERIVED

• 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.

  PMID: 38536225 DERIVED

• 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.

  PMID: 37647105 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Alcohol Drinking; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Drinking Behavior; Chemically-Induced Disorders

Study Officials

• Daniel V Vigo, MD, Lic. Psych, DrPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinded in that only the investigators (including the statistician) will be blinded to the treatment group assignment when examining the primary hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: November 4, 2022
• Study Start: September 28, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CA (1)