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

Primary Purpose

Anxiety Disorders, Depressive Disorder, Eating Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SilverCloud Health Intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Palo Alto University
  • University of Michigan
  • Washington University School of Medicine
  • Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Coached Intervention

Referral to Counseling Center

Arm Description

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.

This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 25, 2019
Last Updated
October 19, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), Palo Alto University, University of Michigan, Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT04162847
Brief Title
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Acronym
iAIM EDU
Official Title
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), Palo Alto University, University of Michigan, Penn State University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorder, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Coached Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Referral to Counseling Center
Arm Type
No Intervention
Arm Description
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
Intervention Type
Device
Intervention Name(s)
SilverCloud Health Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the mobile mental health platform, compared to usual care, in changing the number of individuals with mental health disorders.
Description
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
Time Frame
baseline, 6 weeks, 6 months, and 2 years
Secondary Outcome Measure Information:
Title
Number of Participants who receive treatment on the mobile mental health platformed compared to number of participants who receive treatment in the control group.
Description
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.
Time Frame
6 weeks, 6 months, and 2 years
Title
Effectiveness of the mobile mental health platform, compared to usual care, in changing disorder-specific symptoms.
Description
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.
Time Frame
baseline, 6 weeks, 6 months, and 2 years
Title
Effectiveness of the mobile mental health platform, compared to usual care, in changing quality of life and functioning.
Description
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.
Time Frame
baseline, 6 months, and 2 years
Other Pre-specified Outcome Measures:
Title
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.
Description
Avoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale.
Time Frame
baseline, 6 weeks, 6 months, 2 years
Title
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.
Description
Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form.
Time Frame
baseline, 6 weeks, 6 months, 2 years
Title
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
Description
Dietary restraint will be measured using the Eating Disorder Examination-Questionnaire Restraint subscale and change in weight/shape concerns using the Weight Concerns Scale.
Time Frame
baseline, 6 weeks, 6 months, 2 years
Title
Examine if the mobile intervention changes in dysfunctional cognitions and if changes in dysfunctional cognitions are associated with clinical benefit.
Description
Change in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2.
Time Frame
baseline, 6 weeks, 6 months, 2 years
Title
Examine if the mobile intervention changes cognitive-behavioral therapy (CBT) skills and if changes in CBT skills are associated with clinical benefit.
Description
Change in CBT skills will be measured using the self-report version of the Skills of Cognitive Therapy Scale.
Time Frame
baseline, 6 weeks, 6 months, 2 years
Title
Identify other putative mediators of change.
Description
To identify other putative mediators of change we will look at early engagement in help services, number of sessions completed, and rapid response.
Time Frame
baseline, 6 weeks, 6 months, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Wilfley, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pennsylvania State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34049053
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.
Results Reference
derived

Learn more about this trial

Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

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