Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Anxiety Disorders Clinical Trial

— iAIM EDU  

Official title:

Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04162847
• Other study ID #: 201901073
• Secondary ID: R01MH115128
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6256
• Est. completion date: December 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Eating Disorders
• Feeding and Eating Disorders
• Mental Disorders

Intervention

Device:
• SilverCloud Health Intervention
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Palo Alto University	Palo Alto	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Pennsylvania State University	State College	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH), Palo Alto University, Penn State University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Avoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale.	baseline, 6 weeks, 6 months, 2 years
Other	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.	Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form.	baseline, 6 weeks, 6 months, 2 years
Other	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	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
Other	Examine if the mobile intervention changes in dysfunctional cognitions and if changes in dysfunctional cognitions are associated with clinical benefit.	Change in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2.	baseline, 6 weeks, 6 months, 2 years
Other	Examine if the mobile intervention changes cognitive-behavioral therapy (CBT) skills and if changes in CBT skills are associated with clinical benefit.	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
Other	Identify other putative mediators of change.	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
Primary	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	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
Secondary	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
Secondary	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