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

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ClinicalTrials.gov Identifier: NCT04162847
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2019
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Palo Alto University
University of Michigan
Penn State University
Information provided by (Responsible Party):
Denise Wilfley, Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Depressive Disorder Eating Disorders Device: SilverCloud Health Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7884 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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.
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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162847


Locations
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United States, California
Palo Alto University
Palo Alto, California, United States, 94304
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Pennsylvania State University
State College, Pennsylvania, United States, 16802
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Palo Alto University
University of Michigan
Penn State University
Investigators
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Principal Investigator: Denise Wilfley, PhD Washington University School of Medicine
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Responsible Party: Denise Wilfley, Scott Rudolph University Professor of Psychiatry, Medicine, Pediatrics, and Psychological & Brain Sciences, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04162847    
Other Study ID Numbers: 201901073
R01MH115128 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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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
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Feeding and Eating Disorders
Mental Disorders
Pathologic Processes
Mood Disorders