Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Study 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.

Official Title
-----------------
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Conditions
-----------------
Anxiety Disorders, Depressive Disorder, Eating Disorders

Intervention / Treatment
-----------------
* Device: SilverCloud Health Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Coached Intervention<br>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<br>* 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.<br>|
| No Intervention: Referral to Counseling Center<br>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. | 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. | 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. | 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. | 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 |