Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial (Preprint)
Authors: Wang Angel Y , Vereschagin Melissa , Richardson Chris G , Xie Hui , Hudec Kristen L , Munthali Richard J , Munro Lonna , Leung Calista , Kessler Ronald C , Vigo Daniel V 
Published: May 2023

BACKGROUND

University life typically occurs during a period of life transition, where the incidence of mental health and substance use problems and disorders peaks. However, relatively few students obtain effective treatment and support. e-Interventions have proven effective in improving the psychological outcomes of university students and have the potential to provide scalable services that can easily integrate into existing models of care. <i>Minder</i> is a mobile app codeveloped with university students that offers users a collection of evidence-based interventions tailored to help university students maintain their mental health and well-being and manage their substance use.

OBJECTIVE

This paper describes the protocol for a randomized controlled trial (RCT) that aims to assess the effectiveness of the <i>Minder</i> app in improving the mental health and substance use outcomes of university students.

METHODS

This study is a 2-arm, parallel assignment, single-blinded, 30-day RCT with 1 intervention group and 1 waitlist control group. Overall, 1496 (748 per trial arm) university students from the University of British Columbia Vancouver Campus (N=54,000) who are aged ≥17 years, have a smartphone with Wi-Fi or cellular data, and speak English will be recruited via a variety of web-based and offline strategies. Participants will be randomized into the intervention or control group after completing a baseline survey. Those randomized into the intervention group will gain immediate access to the <i>Minder</i> app and will be assessed at 2 weeks and 30 days. Those randomized into the control group will be given access to the app content after their follow-up assessment at 30 days. The primary outcomes are measured from baseline to follow-up at 30 days and include changes in general anxiety symptomology, depressive symptomology, and alcohol consumption risk measured by the General Anxiety Disorder 7-Item scale, Patient Health Questionnaire 9-Item scale, and US Alcohol Use Disorders Identification Test-Consumption Scale, respectively. Secondary outcomes include measures related to changes in the frequency of substance use, mental well-being, self-efficacy in managing mental health and substance use, readiness to change, and self-reported use of mental health services and supports (including referral) from baseline to follow-up at 30 days.

RESULTS

Trial recruitment and data collection began in September 2022, and the completion of data collection for the trial is anticipated by June 2023. As of May 10, 2023, a total of 1425 participants have been enrolled.

CONCLUSIONS

The RCT described in this protocol paper will assess whether the <i>Minder</i> app is effective in improving the mental health and substance use outcomes of a general population of Canadian university students. Additional secondary outcome research aims to explore additional outcomes of interest for further research and better understand how to support students’ general mental well-being.

CLINICALTRIAL

ClinicalTrials.gov NCT05606601; https://clinicaltrials.gov/ct2/show/NCT05606601

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/49364