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N/A N=6,205 Randomized Treatment

Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Anxiety Disorders · Depressive Disorder · Eating Disorders

Enrolled (actual)
6,205
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. — 2264; 2274; 839; 828 Participants — p=.76

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SilverCloud Health Intervention (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders.
2264; 2274; 839; 828; 1764; 1896 .76
SECONDARY
Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group.
2308; 938; 1904 .000 sig
SECONDARY
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms.
11.65; 11.68; 8.32; 9.43; 8.61; 9.29 .000 sig
SECONDARY
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning.
34.11; 33.89; 36.41; 35.95; 37.85; 36.93 .48

Summary

The prevalence of mental health problems among college populations has risen steadily in recent decades, with one third of today's students struggling with anxiety, depression, or an eating disorder (ED). Yet, only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach for detecting mental health problems and engaging college students in services. The investigators have developed a transdiagnostic, low-cost mobile health targeted prevention and intervention platform that uses population-level screening for engaging college students in tailored services that address common mental health problems. This care delivery system represents an ideal model given its use of evidence-based mobile programs, a transdiagnostic approach that addresses comorbid mental health issues, and personalized screening and intervention to increase service uptake, enhance engagement, and improve outcomes. Further, this service delivery model harnesses the expertise of an interdisciplinary team of behavioral scientists, college student mental health scholars, technology researchers, and health economists. This work bridges the study team's collective leadership over the past 25 years in successfully implementing a population-based screening program in more than 160 colleges and demonstrating the effectiveness of Internet-based programs for targeted prevention and intervention for anxiety, depression, and EDs. Through this study, Investigators will test the impact of this mobile mental health platform for service delivery in a large-scale trial across a diverse range of U.S. colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or EDs (excluding anorexia nervosa, for which more intensive medical monitoring is warranted) and who are not currently engaged in mental health services will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). Participants in the study will be enrolled for 2 years and asked to complete surveys at baseline, 6 weeks, 6 months, and 2 years.

Eligibility Criteria

Inclusion Criteria

  • Undergraduate students at participating colleges and universities who are 18 years old and older.
  • Students who screen has high risk or clinical/subclinical for anxiety, depression, and, eating disorders.
  • Students who are not currently in treatment, i.e., in the past month

Exclusion Criteria

  • Students who do not own a smartphone
  • Students who are currently engaged in mental health treatment
  • Students with anorexia nervosa
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04162847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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