Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND University-life usually happens during a period of transition in life during which the incidence of mental health and substance use problems and disorders peak. However, relatively few students obtain effective treatment and support. E-interventions have been proven effective in improving psychological outcomes of university students and they have the potential to provide scalable services that can be easily integrated into existing models of care. Minder is a mobile application co-developed with university students that offers users a collection of evidence-based interventions that have been tailored to help university students maintain their mental health and wellbeing, as well as manage their substance use. OBJECTIVE The aim of this protocol paper is to provide a description of the randomized controlled trial that aims to assess the effectiveness of the Minder mobile app in improving the mental health and substance use outcomes of university students. METHODS This is a 2-arm parallel assignment single blinded 30-day randomized controlled trial with 1 intervention group and 1 waitlist control group. A total of 1496 (748 per trial arm) university students at the Vancouver Campus of the University of British Columbia (N = 54000) who are 17 years of age or older, have a smartphone with Wi-Fi or cellular data, and speak English will be recruited via a variety of online and offline strategies. Participants will be randomized into either the intervention or control group after completion of a baseline survey. Those randomized into the intervention group will gain immediate access to the Minder app and 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, changes in anxious and depressive symptomology, as well as changes in alcohol consumption risk measured by the General Anxiety Disorder 7-Item (GAD-7) scale, Patient Health Questionnaire 9-item (PHQ-9) scale, and the consumption component of the Alcohol Use Disorders Identification Test, adapted for Use in the United States (USAUDIT-C) respectively. Secondary outcomes include measures related to changes in frequency of substance use, changes in mental well-being, changes in self-efficacy in managing mental health and substance use, changes in readiness to change, and changes in self-reported use of mental health services and supports (including referral) from baseline to follow-up at 30 days. RESULTS This study was registered on ClinicalTrials.gov (NCT05606601) on November 4, 2022. Trial recruitment and data collection began in September 2022 and completion of data collection for trial is anticipated by June 2023. As of May 10, 2022, 1425 participants have been enrolled. CONCLUSIONS The randomized controlled trial described in this protocol paper will assess whether the Minder app is effective in improving the mental health (PHQ-9 and GAD-7) and substance use outcomes (USAUDIT-C) of a general population of Canadian university students. Further secondary outcome research aims to explore additional outcomes of interest for further research and to better understand how to support students' general mental wellbeing. CLINICALTRIAL ClinicalTrials.gov NCT05606601; https://clinicaltrials.gov/ct2/show/NCT05606601