Helping HAND: Healing Anorexia Nervosa Digitally

NCT05499676 | Completed Results DMC

• 2 other identifiers: 202202113R34MH127203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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).

  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.

  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.

  baseline, 6 weeks, 6 months, and 9 months

Other Outcomes (2)

• Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care.

  6 months and 9 months

• Number of Participants Who Achieved Full Recovery in the Mobile App Conditions Compared to Referral to Usual Care, as Assessed With BMI, the Stanford-Washington University Eating Disorders Screen, and EDE-Q.

  6 months and 9 months

Study Arms (3)

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.

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.

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.

Interventions

SilverCloud Health Mobile Intervention DEVICE

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.

Mobile Coached Intervention; Mobile Coached Intervention Plus Social Networking

Social Networking Intervention: Facebook DEVICE

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

Mobile Coached Intervention Plus Social Networking

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Palo Alto University

Palo Alto, California, 94304, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: Ellen Fitzsimmons-Craft
• Organization: Washington University in St. Louis

fitzsimmonse@wustl.edu

3143413238

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: December 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)