Anorexia NervosaNCT05499676

Helping HAND: Healing Anorexia Nervosa Digitally

A study testing SilverCloud Health Mobile Intervention and Social Networking Intervention: Facebook in people with Anorexia Nervosa, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Anorexia Nervosa
What is being tested?: SilverCloud Health Mobile Intervention and Social Networking Intervention: Facebook
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 3 sitesUnited States
Study dates: 1 Dec 2022to 1 Mar 2025
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Cisgender women who are 18 years old and older, who own a mobile phone, speak English, are U.S. residents, have a BMI greater than or equal to 17, who are connected with a physician (such as a primary care provider), who are not using a feeding tube, and who have been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months.

Who cannot join

Individuals who are not cisgender women.
Individuals under 18 years old.
Individuals who do not own a mobile phone.
Individuals who have not been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months).
Individuals who are not connected with a physician (such as a primary care provider)
Individuals who have a BMI below 17.0
Individuals who are currently using a feeding tube

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Columbia University
New York, New York, 10032
Palo Alto University
Palo Alto, California, 94304
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Development and Pilot Testing of a Cognitive-Behavioral Therapy-Guided Self-Help Mobile App for the Post-Acute Treatment of Anorexia Nervosa

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period

Read the detailed description

Anorexia nervosa (AN) is a costly and life-threatening illness. Patients with severe AN are often treated in the acute setting, but relapse after treatment is common. Further, the discharge criterion in acute settings is typically weight restoration. However, research has indicated that weight-based recovery is not "enough" and that full recovery involves physical, behavioral, and psychological components. Cognitive-behavioral therapy (CBT) is useful with this population, including following discharge, and may aid in addressing psychological symptoms, achieving full recovery, and decreasing relapse. However, very few patients have access to providers trained in these techniques. mHealth technologies have great potential to exponentially increase access to high-quality services for the post-acute treatment of AN by addressing barriers to treatment, but to date, research on these approaches has been extremely limited. A guided self-help CBT-based mobile app, StudentBodies-Eating Disorders (SB-ED), has been successfully developed, demonstrating effectiveness among college women with binge/purge-type EDs. At the same time, there is demonstrated support for in-person CBT for the post-acute care and relapse prevention of adult AN. The overarching goal of this R34 is thus to develop and test a CBT-based, coached mobile app to address the post-acute care and relapse prevention.

Conditions: Anorexia Nervosa
Being tested: SilverCloud Health Mobile Intervention, Social Networking Intervention: Facebook
Medical subject headings: Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SilverCloud Health Mobile InterventionDevice
SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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.
Social Networking Intervention: FacebookDevice
Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group

Study groups in NCT05499676
Study group	Role	What they receive
Mobile Coached Intervention	Experimental	Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Receives: Device: SilverCloud Health Mobile Intervention
Mobile Coached Intervention Plus Social Networking	Experimental	Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Receives: Device: SilverCloud Health Mobile Intervention; Device: Social Networking Intervention: Facebook
Treatment as Usual	No intervention	This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD ) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire.
Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. The main outcome variable will be the EDE-Q Global score, an overall measure of eating disorder psychopathology. Scores possible range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.
Measured: baseline, 6 weeks, 6 months, and 9 months

Secondary outcomes (4)

Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. For this secondary outcome, investigators will examine eating disorder behavior frequencies from the EDE-Q.
Measured: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
Investigators will use current BMI as derived from self-reported height, which has shown to be accurate in adult ED populations, and weight assessed by a digital wireless scale. At each of the study timepoints, a study coordinator will schedule a time with the participant to take their weight while they are on a Zoom call with the coordinator. Participants will be instructed to take off their shoes, wear light clothing, and empty their pockets, similar to the instructions that would be provided if this measurement were being taken in person. Given the use of a wireless scale, the measurement will be able to be immediately and automatically sent to the research team.
Measured: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
Investigators will use the Patient Health Questionnaire (PHQ-9), a 9-item measure that is widely used to assess presence of possible depression and severity. Scores possible range from 0 to 27, with higher scores indicating greater severity of depression.
Measured: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
Investigators will use the Clinical Impairment Assessment (CIA), which is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features. Scores range from 0 to 48 with higher scores indicating higher levels of impairment.
Measured: baseline, 6 weeks, 6 months, and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20221 Mar 2025

First posted12 Aug 2022
Study start1 Dec 2022
Primary completion1 Mar 2025
Study completion1 Mar 2025

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.
Other trials for Anorexia NervosaStudies 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: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05499676
Sponsor's protocol ID: 202202113
Other IDs: R34MH127203
Status last verified: May 2026
First submitted: 9 Aug 2022
Last updated: 5 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified data will not be shared on the National Institute of Mental Health Data Archive, as this is a pilot study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anorexia Nervosa trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Pilot Testing of a Cognitive-Behavioral Therapy-Guided Self-Help Mobile App for the Post-Acute Treatment of Anorexia Nervosa
ClinicalTrials.gov ID: NCT05499676
Acronym / sponsor ID: 202202113
Conditions: Anorexia Nervosa
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Dec 2022 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 12 Aug 2022 (actual)
Results: Posted 5 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Mobile Coached Intervention	Experimental	Device: SilverCloud Health Mobile InterventionParticipants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged.
Mobile Coached Intervention Plus Social Networking	Experimental	Device: SilverCloud Health Mobile Intervention, Device: Social Networking Intervention: FacebookParticipants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged.
Treatment as Usual	No intervention	–This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD ) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Cisgender women who are 18 years old and older, who own a mobile phone, speak English, are U.S. residents, have a BMI greater than or equal to 17, who are connected with a physician (such as a primary care provider), who are not using a feeding tube, and who have been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months.

Key exclusion criteria (7 listed)

Individuals who are not cisgender women.
Individuals under 18 years old.
Individuals who do not own a mobile phone.
Individuals who have not been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months).
Individuals who are not connected with a physician (such as a primary care provider)

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 Mobile InterventionSilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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, Mobile Coached Intervention Plus Social Networking
Social Networking Intervention: FacebookFacebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group	Device	Mobile Coached Intervention Plus Social Networking

Primary outcome

Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire.
Time frame: baseline, 6 weeks, 6 months, and 9 months
Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. The main outcome variable will be the EDE-Q Global score, an overall measure of eating disorder psychopathology. Scores possible range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.

4 secondary outcomes

Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Time frame: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
Time frame: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
Time frame: baseline, 6 weeks, 6 months, and 9 months
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
Time frame: baseline, 6 weeks, 6 months, and 9 months

Results and safety

Results posted to the registry on 5 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment as Usual	30	30
Mobile Coached Intervention Plus Social Networking	30	29
Mobile Coached Intervention	30	30

Primary outcome: Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire.

Time frame: baseline, 6 weeks, 6 months, and 9 months. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Treatment as Usual n = 30	Mobile Coached Intervention Plus Social Networking n = 30	Mobile Coached Intervention n = 30
Baseline Assessment	3.83 (1.03)	3.57 (1.50)	3.52 (1.16)
6 Week Follow Up Assessment	3.42 (1.11)	3.20 (1.57)	3.44 (1.49)
6 Month Follow Up Assessment	3.49 (1.35)	3.46 (1.72)	3.18 (1.75)
9 Month Follow Up Assessment	3.27 (1.20)	3.25 (1.72)	3.08 (1.54)

Treatment as Usual: Mean Difference (Net): -0.41 (95% CI -0.62 to -0.19), p = 0.0003, Mixed Models Analysis
Mobile Coached Intervention Plus Social Networking: Mean Difference (Net): -0.16 (95% CI -0.4 to 0.08), p = 0.1824, Mixed Models Analysis
Mobile Coached Intervention: Mean Difference (Net): -0.27 (95% CI -0.5 to -0.05), p = 0.0188, Mixed Models Analysis

Population analysed: Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment as Usual	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Mobile Coached Intervention Plus Social Networking	1 of 30 (3.3%)	0 of 30 (0%)	1 of 30
Mobile Coached Intervention	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified data will not be shared on the National Institute of Mental Health Data Archive, as this is a pilot study.

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 7 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 5 May 2026). 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 App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire. (time frame: baseline, 6 weeks, 6 months, and 9 months). 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 NCT05499676.

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 5 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.