Anxiety DisordersiAIM EDUNCT04162847
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
A study testing SilverCloud Health Intervention in people with Anxiety Disorders and Depressive Disorder, run by Washington University School of Medicine at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Eating Disorders
- What is being tested?
- SilverCloud Health Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,205 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Students who do not own a smartphone
- Students who are currently engaged in mental health treatment
- Students with anorexia nervosa
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Palo Alto University
Palo Alto, California, 94304
Washington University School of Medicine
St Louis, Missouri, 63110
Pennsylvania State University
State College, Pennsylvania, 16802
About this study
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.
- Conditions
- Anxiety Disorders, Depressive Disorder, Eating Disorders
- Being tested
- SilverCloud Health Intervention
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverCloud Health InterventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Coached Intervention | Experimental | 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. Receives: Device: SilverCloud Health Intervention |
| Referral to Counseling Center | No intervention | This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 weeks, 6 months, and 2 years
Secondary outcomes (3)
Number of Participants Who Receive Treatment on the Mobile Mental Health Platform 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 or by reporting taking a new antidepressant or anti-anxiety medication in the control condition.
Measured: 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, this scale has a minimum value of 0 and a maximum value of 13, a lower score means a better outcome. The Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, this scale has a minimum value of 0 and a maximum value of 31, a lower score means a better outcome. The Panic Disorder Self Report (PDSR) for panic disorder, this scale has a minimum value of 0 and a maximum value of 24, a lower score means a better outcome. The Patient Health Questionnaire-9 (PHQ-9) for depression, this scale has a minimum value of 0 and a maximum value of 27, a lower score means a better outcome. The Eating Disorder Examination-Questionnaire (EDE-Q) for eating disorders, this scale has a minimum value of 0 and a maximum value of 6, a lower score means a better outcome.
Measured: 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 for both the physical component and mental component.
Measured: baseline, 6 months, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start7 Oct 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Palo Alto University, University of Michigan, Penn State University
- Responsible party
- Principal investigator, Denise Wilfley, Washington University School of Medicine
- Investigators
- Denise Wilfley, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162847
- Sponsor's protocol ID
- 201901073
- Other IDs
- R01MH115128
- Acronym
- iAIM EDU
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2019
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared on the National Institute of Mental Health Data Archive as required by the National Institute of Health.
Publications
Newman MG, Fitzsimmons-Craft EE, Baik SY, Zainal NH, Calderon A, Rackoff GN, Firebaugh ML, Rojas-Ashe E, Leykin Y, Lew D, Eisenberg D, Taylor CB, Wilfley DE. Population-based RCT of a digital cognitive-behavioural guided self-help intervention for anxiety, depression and eating disorders in college students. Nat Hum Behav. 2026 Jul;10(7):1246-1259. doi: 10.1038/s41562-026-02454-z. Epub 2026 May 7.
PubMed 42098266Basterfield C, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. Internalizing psychopathology and its links to suicidal ideation, dysfunctional attitudes, and help-seeking readiness in a national sample of college students. J Affect Disord. 2024 Apr 1;350:255-263. doi: 10.1016/j.jad.2024.01.058. Epub 2024 Jan 13.
PubMed 38224742Grammer 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.
PubMed 34049053
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
- ClinicalTrials.gov ID
- NCT04162847
- Acronym / sponsor ID
- iAIM EDU / 201901073
- Conditions
- Anxiety Disorders, Depressive Disorder, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,205 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Palo Alto University, University of Michigan, Penn State University
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Coached Intervention | Experimental | Device: SilverCloud Health InterventionThis 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. |
| Referral to Counseling Center | No intervention | –This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Students who do not own a smartphone
- Students who are currently engaged in mental health treatment
- Students with anorexia nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilverCloud Health InterventionSilverCloud 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. | Device | Mobile Coached Intervention |
Primary outcome
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
3 secondary outcomes
Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group.
Time frame: 6 weeks, 6 months, and 2 years
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42098266Newman MG, Fitzsimmons-Craft EE, Baik SY, Zainal NH, Calderon A, Rackoff GN, Firebaugh ML, Rojas-Ashe E, Leykin Y, Lew D, Eisenberg D, Taylor CB, Wilfley DE. Population-based RCT of a digital cognitive-behavioural guided self-help intervention for anxiety, depression and eating disorders in college students. Nat Hum Behav. 2026 Jul;10(7):1246-1259. doi: 10.1038/s41562-026-02454-z. Epub 2026 May 7.
- Derived from this study: PubMed 38224742Basterfield C, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. Internalizing psychopathology and its links to suicidal ideation, dysfunctional attitudes, and help-seeking readiness in a national sample of college students. J Affect Disord. 2024 Apr 1;350:255-263. doi: 10.1016/j.jad.2024.01.058. Epub 2024 Jan 13.
- Derived from this study: PubMed 34049053Grammer 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.
- Individual participant dataSharing planned: Yes. De-identified data will be shared on the National Institute of Mental Health Data Archive as required by the National Institute of Health.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Wilfley, PhD principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SilverCloud Health Intervention in people with Anxiety Disorders and Depressive Disorder, run by Washington University School of Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.