Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention

NCT04636840 | Completed Phase 1 Results DMC FDA Device

• 1 other identifier: 1R34MH119170-01
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical or subclinical eating disorders (EDs) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ED symptoms often emerge in adolescence, with peak onset age in the teenage years. Early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. Most (80%) individuals with EDs, including teens with EDs (TwEDs), do not receive treatment. Due to major barriers to access and to the delivery of treatment for TwEDs, there is a need for a new model of service delivery that can identify and help TwEDs. We demonstrated our ability to harness social media to identify and efficiently recruit large numbers of TwEDs. Our team has successfully developed a guided self-help cognitive behavioral therapy (CBT)-based mobile app for previous studies and have adapted this app to address the specific needs of TwEDs. In proposed study, we will test this updated mHealth intervention, which includes simplified language and tailored content relevant to adolescent issues and a social networking feature designed to facilitate group exchanges. This mHealth intervention will be investigated among 161 TwEDs recruited from Instagram/Facebook to test preliminary efficacy and feasibility of this mHealth intervention to improved eating disorder symptoms among TwEDs not currently engaged in treatment. We will also garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with mHealth intervention content and features. Participants will be randomized to one of 3 study arms, including a control group (self-help version of the app), a group with access to the coached mobile app only, and a group with access to the coached mobile app plus social networking feature. We hypothesized that those with access to the coached mobile app intervention will have improved ED outcomes in comparison to the control group, and that those with access to the additional social networking feature will have the most improvement in ED symptoms out of all three groups.

Conditions

Eating Disorders

Keywords

mHealth; eating disorders; bulimia nervosa; binge eating disorder; teens; adolescents; social media

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Psychopathology

  Eating disorder psychopathology was assessed using the self-report Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q Global score was calculated as the mean of the Restraint, Eating Concern, Shape Concern, and Weight Concern subscales (items scored 0-6), with higher scores indicating greater severity of eating disorder symptoms.

  Baseline, 6 weeks, 3 months, 6 months

Secondary Outcomes (2)

• Quality of Life Scores

  Baseline, 6 weeks, 3 months, 6 months

• Total Time Spent on the App

  3 months

Other Outcomes (2)

• Depression Symptoms

  Baseline, 6 weeks, 3 months, 6 months

• Anxiety Symptoms

  Baseline, 6 weeks, 3 months, 6 months

Study Arms (3)

Control Group

NO INTERVENTION

Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App

Experimental Group A- Mobile App with Social Networking Feature

EXPERIMENTAL

Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support.

Device: Space From Body and Eating Concerns- Teen

Experimental Group B- Mobile App Only

EXPERIMENTAL

Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App.

Device: Space From Body and Eating Concerns- Teen

Interventions

Space From Body and Eating Concerns- Teen DEVICE

Mobile application with coaching component

Experimental Group A- Mobile App with Social Networking Feature; Experimental Group B- Mobile App Only

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• US Resident
• Owns or has daily access to an iOS or Android smartphone
• English-speaking
• Screen Positive for a DSM-5 subclinical/clinical eating disorder other than anorexia nervosa (AN) or at high risk for an eating disorder

You may not qualify if:

• Currently Engaged in eating disorder treatment
• Screen Positive for Anorexia Nervosa
• Wards of the State or Foster Children

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Patricia Cavazos-Rehg
• Organization: Washington University School of Medicine

pcavazos@wustl.edu

314-362-2152

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: December 18, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 18, 2023
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.
• Access Criteria: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.

Locations

US (1)