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Completed

NCT Number: NCT04636840

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Space From Body and Eating Concerns- Teen

Device

Mobile application with coaching component

Primary outcomes

  1. Eating Disorder Psychopathology

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    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.

Secondary outcomes

  1. Quality of Life Scores

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    Health-related quality of life was assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales. The total score ranges from 0 to 100 and is calculated as the mean of all answered items (i.e., sum of transformed item scores divided by the number of items answered), with higher scores indicating better quality of life (fewer problems).

  2. Total Time Spent on the App

    Time frame: 3 months

    Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds.

Other outcomes

  1. Depression Symptoms

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    Participants' depression symptoms were assessed using the Patient Health Questionnaire (PHQ-8). This questionnaire includes eight items with scores ranging from 0 to 24 (the ninth item assessing suicidal ideation was removed, consistent with other remote and digital health studies among teens). The total score ranges from 0 to 24, with a higher score indicating more severe depressive symptoms.

  2. Anxiety Symptoms

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    Anxiety symptoms were assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED; 41 items). Participants rated each item based on how true it was for the last 3 months (0 = not true/hardly ever true, 1 = somewhat true/sometimes true, 2 = very true/often true).

    The total score is the sum of all items (range 0-82). Higher scores indicate more severe anxiety symptoms.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Palo Alto University
  • SilverCloud Health

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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