Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations (iAIM EDU)

October 19, 2023 updated by: Denise Wilfley, Washington University School of Medicine

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.

Study Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

6256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Pennsylvania
      • State College, Pennsylvania, United States, 16802
        • Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Coached Intervention
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.
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.
No Intervention: Referral to Counseling Center
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 6 weeks, 6 months, and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who receive treatment on the mobile mental health platformed compared to number of participants who receive treatment in the control group.
Time Frame: 6 weeks, 6 months, and 2 years
Uptake will be assessed as engaging in at least one session of mental health service use either online or in-person. This will be assessed based on actual use of the mobile program in the intervention condition and self-report of mental health services utilized in the control condition.
6 weeks, 6 months, and 2 years
Effectiveness of the mobile mental health platform, compared to usual care, in changing disorder-specific symptoms.
Time Frame: baseline, 6 weeks, 6 months, and 2 years
Analyses will be conducted within each disorder subgroup separately. We will use the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, the 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 Eating Disorder Examination-Questionnaire (EDE-Q) for eating disorders.
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.
Time Frame: baseline, 6 months, and 2 years
Impairment/quality of life will be assessed using the Short Form-12 Health Survey. This scale has a minimum value of 0 and a maximum value of 100, a higher score means a better outcome.
baseline, 6 months, and 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: baseline, 6 weeks, 6 months, 2 years
Avoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale.
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.
Time Frame: baseline, 6 weeks, 6 months, 2 years
Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form.
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
Time Frame: baseline, 6 weeks, 6 months, 2 years
Dietary restraint will be measured using the Eating Disorder Examination-Questionnaire Restraint subscale and change in weight/shape concerns using the Weight Concerns Scale.
baseline, 6 weeks, 6 months, 2 years
Examine if the mobile intervention changes in dysfunctional cognitions and if changes in dysfunctional cognitions are associated with clinical benefit.
Time Frame: baseline, 6 weeks, 6 months, 2 years
Change in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2.
baseline, 6 weeks, 6 months, 2 years
Examine if the mobile intervention changes cognitive-behavioral therapy (CBT) skills and if changes in CBT skills are associated with clinical benefit.
Time Frame: baseline, 6 weeks, 6 months, 2 years
Change in CBT skills will be measured using the self-report version of the Skills of Cognitive Therapy Scale.
baseline, 6 weeks, 6 months, 2 years
Identify other putative mediators of change.
Time Frame: baseline, 6 weeks, 6 months, 2 years
To identify other putative mediators of change we will look at early engagement in help services, number of sessions completed, and rapid response.
baseline, 6 weeks, 6 months, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Denise Wilfley, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 201901073
  • R01MH115128 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared on the National Institute of Mental Health Data Archive as required by the National Institute of Health.

IPD Sharing Time Frame

The data will be available at the end of the study, five years from now.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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