Background Digital mental health interventions are increasingly prevalent in the current context of rapidly evolving technology, and research indicates that they yield effectiveness outcomes comparable to in-person treatment. Integrating professionals (ie, psychologists and physicians) into digital mental health interventions has become common, and the inclusion of guidance within programs can increase adherence to interventions. However, employing professionals to enhance mental health programs may undermine the scalability of digital interventions. Therefore, delegating guidance tasks to paraprofessionals (peer supporters, technicians, lay counsellors, or other nonclinicians) can help reduce costs and increase accessibility. Objective This systematic review and meta-analysis evaluates the effectiveness, adherence, and other process outcomes of nonclinician-guided digital mental health interventions. Methods Four databases (MEDLINE, Embase, CINAHL, and PsycINFO) were searched for randomized controlled trials published between 2010 and 2020 examining digital mental health interventions. Three journals that focus on digital intervention were hand searched; gray literature was searched using ProQuest and the Cochrane Central Register of Control Trials (CENTRAL). Two researchers independently assessed risk of bias using the Cochrane risk-of-bias tool version 2. Data were collected on effectiveness, adherence, and other process outcomes, and meta-analyses were conducted for effectiveness and adherence outcomes. Nonclinician-guided interventions were compared with treatment as usual, clinician-guided interventions, and unguided interventions. Results Thirteen studies qualified for inclusion. Nonclinician-guided interventions yielded higher posttreatment effectiveness outcomes when compared to conditions involving control programs (eg, online psychoeducation and monitored attention control) or wait-list controls (k=7, Hedges g=–0.73; 95% CI –1.08 to –0.38). There were also significant differences between nonclinician-guided interventions and unguided interventions (k=6, Hedges g=–0.17; 95% CI –0.23 to –0.11). In addition, nonclinician-guided interventions did not differ in effectiveness from clinician-guided interventions (k=3, Hedges g=0.08; 95% CI –0.01 to 0.17). These results suggest that guided digital mental health interventions are helpful to improve mental health outcomes regardless of the qualifications of the individual performing the intervention, and that the presence of a nonclinician guide improves effectiveness outcomes compared to having no guide. Nonclinician-guided interventions did not yield significantly different adherence outcomes when compared with unguided interventions (k=3, odds ratio 1.58; 95% CI 0.51 to 4.92), although a general trend of improved adherence was observed within nonclinician-guided interventions. Conclusions Integrating paraprofessionals and nonclinicians appears to improve the outcomes of digital mental health interventions, and may also enhance adherence outcomes (though this trend was nonsignificant). Further research should focus on the specific types of tasks these paraprofessionals can successfully provide (ie, psychosocial support, therapeutic alliance, and technical augmentation) and their associated outcomes. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020191226; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=191226

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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. Minder 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 Minder 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 Minder 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 Minder 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. Trial Registration ClinicalTrials.gov NCT05606601; https://clinicaltrials.gov/ct2/show/NCT05606601 International Registered Report Identifier (IRRID) DERR1-10.2196/49364

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

BACKGROUND Digital mental health interventions are increasingly prevalent in the current context of rapidly evolving technology, and research indicates that they yield effectiveness outcomes comparable to in-person treatment. Integrating professionals (i.e. psychologists, physicians) into digital mental health interventions has been common, and the inclusion of guidance within programs can increase adherence to interventions. However, employing professionals to enhance mental health programs may undermine the scalability of digital interventions. Therefore, delegating guidance tasks to paraprofessionals (peer supporters, technicians, lay counsellors, or other non-clinicians) can help reduce costs and increase accessibility. OBJECTIVE This systematic review and meta-analysis evaluates the effectiveness, adherence, and other process outcomes of non-clinician guided digital mental health interventions. METHODS Four databases (MEDLINE, EMBASE, CINAHL, and PSYCInfo) were searched for randomized controlled trials published between 2010 and 2020 examining digital mental health interventions. Three journals focused on digital intervention were also hand searched and grey literature was searched using ProQuest and the Cochrane Central Register of Control Trials (CENTRAL). Two researchers independently assessed risk of bias using the Cochrane Risk of Bias Tool 2. Data were collected on effectiveness, adherence, and other process outcomes, and meta-analyses were conducted for effectiveness and adherence outcomes. Non-clinician guided interventions were compared with treatment as usual, clinician-guided interventions, and unguided interventions. RESULTS Thirteen studies qualified for inclusion. Results indicate that non-clinician guided interventions yielded higher post-treatment effectiveness outcomes when compared to conditions involving control programs (e.g. online psychoeducation, monitored attention control) or waitlist controls (k=7, Hedges g=-0.73 (95% CI -1.08 to -0.38)). There are significant differences between non-clinician guided interventions and unguided interventions as well (k=6, Hedges g=-0.17 (95% CI -0.23 to -0.11)). In addition, non-clinician guided interventions did not differ in effectiveness from clinician-guided interventions (k=3, Hedges g=0.08 (95% CI -0.01 to 0.17)). These results suggest that guided digital mental health interventions are helpful to improve mental health outcomes regardless of the qualification, and that the presence of a non-clinician guide improves effectiveness outcomes more than no guidance. Non-clinician guided interventions did not yield significantly different effects on adherence outcomes when compared with unguided interventions (k=3, OR 1.58 (95% CI 0.51 to 4.92)), although a general trend of improved adherence was observed within non-clinician guided interventions. CONCLUSIONS Integrating paraprofessionals and non-clinicians appear to improve outcomes of digital mental health interventions, and may also enhance adherence outcomes (though the trend was nonsignificant). Further research should focus on the specific types of tasks these paraprofessionals can successfully provide (i.e. psychosocial support, therapeutic alliance, technical augmentation) and their associated outcomes. CLINICALTRIAL The protocol is preregistered on PROSPERO (CRD42020191226).