Clinical trial NCT04162847: Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Official title: Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Eating Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Palo Alto University
name: University of Michigan
name: Penn State University
First posted: 2019-11-14
Enrollment: 6205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders.
timeFrame: baseline, 6 weeks, 6 months, and 2 years
Secondary outcomes:
measure: Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group.
timeFrame: 6 weeks, 6 months, and 2 years
measure: Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms.
timeFrame: baseline, 6 weeks, 6 months, and 2 years
measure: Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning.
timeFrame: baseline, 6 months, and 2 years
Other outcomes:
measure: 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.
timeFrame: baseline, 6 weeks, 6 months, 2 years
measure: 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.
timeFrame: baseline, 6 weeks, 6 months, 2 years
measure: 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
timeFrame: baseline, 6 weeks, 6 months, 2 years
measure: Examine if the Mobile Intervention Changes in Dysfunctional Cognitions and if Changes in Dysfunctional Cognitions Are Associated With Clinical Benefit.
timeFrame: baseline, 6 weeks, 6 months, 2 years
measure: Examine if the Mobile Intervention Changes Cognitive-behavioral Therapy (CBT) Skills and if Changes in CBT Skills Are Associated With Clinical Benefit.
timeFrame: baseline, 6 weeks, 6 months, 2 years
measure: Identify Other Putative Mediators of Change.
timeFrame: baseline, 6 weeks, 6 months, 2 years
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: State College
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine
name: Denise Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.