Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

NCT04162847 | Completed Results DMC FDA Device

• 2 other identifiers: 201901073R01MH115128
• Study Type: interventional
• Target: 6,205
• Locations: 1 country
• Sites: 4

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.

Conditions

Anxiety Disorders; Depressive Disorder; Eating Disorders

Outcome Measures

Primary Outcomes (1)

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

  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

  baseline, 6 weeks, 6 months, and 2 years

Secondary Outcomes (3)

• 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

Other Outcomes (6)

• Examine if the Mobile Intervention Changes Avoidance for Individuals With or at High Risk for Anxiety and if Changes in Avoidance Are Associated With Clinical Benefit.

  baseline, 6 weeks, 6 months, 2 years

• Examine if the Mobile Intervention Changes Behavioral Activation for Individuals With or at High Risk for Depression and if Changes in Behavioral Activation Are Associated With Clinical Benefit.

  baseline, 6 weeks, 6 months, 2 years

• Examine if the Mobile Intervention Changes Dietary Restraint and Weight/Shape Concerns for Individuals With or at High Risk for Eating Disorders and if Changes in Dietary Restraint and Weight/Shape Concerns Are Associated With Clinical Benefit

  baseline, 6 weeks, 6 months, 2 years

Study Arms (2)

Mobile Coached Intervention

EXPERIMENTAL

This group will receive access to the mobile intervention for 6 months. They will be assigned to the primary program (i.e., anxiety, depression, or eating disorders) they screen positive for. If a person screens positive for more than one disorder, they will be given the choice of which program they want to start with. They will also be provided preventive interventions for anxiety, depressive, or eating of disorders they may not have but be at risk for. After two weeks in the program, the coach will assign the components presumed to be essential to intervention effects for comorbid disorder(s) and risk factors.

Device: SilverCloud Health Intervention

Referral to Counseling Center

NO INTERVENTION

This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.

Interventions

SilverCloud Health Intervention DEVICE

SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs for preventing and treating anxiety, depression, and eating disorders as appropriate Participants in this arm will receive the support of a coach to guide them through the program. Participants will be able to communicate with their coach within the program.

Mobile Coached Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Students who do not own a smartphone
• Students who are currently engaged in mental health treatment
• Students with anorexia nervosa

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator
• Palo Alto University: collaborator
• University of Michigan: collaborator
• Penn State University: collaborator

Study Sites (4)

Palo Alto University

Palo Alto, California, 94304, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Pennsylvania State University

State College, Pennsylvania, 16802, United States

Location

Related Publications (2)

• Basterfield C, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. Internalizing psychopathology and its links to suicidal ideation, dysfunctional attitudes, and help-seeking readiness in a national sample of college students. J Affect Disord. 2024 Apr 1;350:255-263. doi: 10.1016/j.jad.2024.01.058. Epub 2024 Jan 13.

  PMID: 38224742 DERIVED

• Grammer AC, Vazquez MM, Fitzsimmons-Craft EE, Fowler LA, Rackoff GN, Schvey NA, Lipson SK, Newman MG, Eisenberg D, Taylor CB, Wilfley DE. Characterizing eating disorder diagnosis and related outcomes by sexual orientation and gender identity in a national sample of college students. Eat Behav. 2021 Aug;42:101528. doi: 10.1016/j.eatbeh.2021.101528. Epub 2021 May 15.

  PMID: 34049053 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Denise Wilfley
• Organization: Washington University in St. Louis School of Medicine

wilfleyd@wustl.edu

3142862079

Study Officials

• Denise Wilfley, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scott Rudolph University Professor of Psychiatry, Medicine, Pediatrics, and Psychological & Brain Sciences

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 14, 2019
• Study Start: October 7, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available at the end of the study, five years from now.
• Access Criteria: The de-identified data will be shared on the National Institute of Mental Health Data Archive and will only be available to other researchers who have access to this platform.

Locations

US (4)