- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04636840
Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
|
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.
|
Mobile application with coaching component
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 weeks, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline, 6 weeks, 3 months, 6 months
|
|
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.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 weeks, 3 months, 6 months
|
|
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. |
Baseline, 6 weeks, 3 months, 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH119170-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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