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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Disorders
• Intervention / Treatment: Device: Space From Body and Eating Concerns- Teen

• Study Type: Interventional
• Enrollment (Anticipated): 161
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App
Experimental: Experimental Group A- Mobile App with Social Networking Feature; 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; Mobile application with coaching component
Experimental: Experimental Group B- Mobile App Only; Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App.	Device: Space From Body and Eating Concerns- Teen; Mobile application with coaching component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Symptoms	Change of eating disorder symptoms as evaluated by the Eating Disorders Examination Questionnaire (EDE-Q) global score.	Baseline, 6 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Scores	Change in quality of life scores among participants will be evaluated using the Pediatric Quality of Life Short Form (PedsQL 4.0).	Baseline, 6 weeks, 3 months, 6 months
Utilization/Uptake of Treatment	Uptake of mental health treatment will include beginning treatment in participants' assigned condition (i.e., uptake of version of app to which they were assigned) or receipt of any other treatment type (i.e., in-person).	Baseline, 6 weeks, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptoms	Change in depression symptoms as evaluated by the Pediatric Health Questionnaire for Adolescents (PHQ-A).	Baseline, 6 weeks, 3 months, 6 months
Anxiety Symptoms	Change in depression symptoms as evaluated by the Screen for Child Anxiety Related Disorders (SCARED).	Baseline, 6 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH); Palo Alto University; SilverCloud Health

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; adolescents; social media; eating disorders; bulimia nervosa; binge eating disorder; teens
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Feeding and Eating Disorders
• Other Study ID Numbers: 1R34MH119170-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be deidentified and uploaded into data sharing structures on the NIMH Data Archive as compliant with funding source requirements.
• IPD Sharing Time Frame: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.
• IPD Sharing Access Criteria: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.

Drug and device information, study documents

• 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