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Clinical Trials/NCT04162847
NCT04162847
Completed
N/A

Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Washington University School of Medicine4 sites in 1 country6,205 target enrollmentOctober 7, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Washington University School of Medicine
Enrollment
6205
Locations
4
Primary Endpoint
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders.
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 7, 2019
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Denise Wilfley

Scott Rudolph University Professor of Psychiatry, Medicine, Pediatrics, and Psychological & Brain Sciences

Washington University School of Medicine

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

Outcomes

Primary Outcomes

Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders.

Time Frame: baseline, 6 weeks, 6 months, and 2 years

Effectiveness of the mobile mental health platform, compared to usual care, in reducing or preventing the number of individuals with mental health disorders (i.e., a positive screen for at least one of anxiety, depression, or eating disorder as the outcome reflecting a "clinical case"), assessed at 6 months and 2 years, with a primary endpoint of 2 years. Clinical case status will be determined using the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, the Panic Disorder Self Report (PDSR) for panic disorder, the Patient Health Questionnaire-9 (PHQ-9) for depression, and the Stanford-Washington University Eating Disorders Screen for eating disorders

Secondary Outcomes

  • Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group.(6 weeks, 6 months, and 2 years)
  • Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms.(baseline, 6 weeks, 6 months, and 2 years)
  • Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning.(baseline, 6 months, and 2 years)

Study Sites (4)

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