Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
Primary Purpose
Eating Disorders
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Space From Body and Eating Concerns- Teen
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring mHealth, eating disorders, bulimia nervosa, binge eating disorder, teens, adolescents, social media
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group
Experimental Group A- Mobile App with Social Networking Feature
Experimental Group B- Mobile App Only
Arm Description
Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App
Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support.
Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App.
Outcomes
Primary Outcome Measures
Eating Disorder Symptoms
Change of eating disorder symptoms as evaluated by the Eating Disorders Examination Questionnaire (EDE-Q) global score.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT04636840
First Posted
November 13, 2020
Last Updated
September 12, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), SilverCloud Health, Palo Alto University
1. Study Identification
Unique Protocol Identification Number
NCT04636840
Brief Title
Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
Official Title
Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH), SilverCloud Health, Palo Alto University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
mHealth, eating disorders, bulimia nervosa, binge eating disorder, teens, adolescents, social media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App
Arm Title
Experimental Group A- Mobile App with Social Networking Feature
Arm Type
Experimental
Arm Description
Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support.
Arm Title
Experimental Group B- Mobile App Only
Arm Type
Experimental
Arm Description
Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App.
Intervention Type
Device
Intervention Name(s)
Space From Body and Eating Concerns- Teen
Intervention Description
Mobile application with coaching component
Primary Outcome Measure Information:
Title
Eating Disorder Symptoms
Description
Change of eating disorder symptoms as evaluated by the Eating Disorders Examination Questionnaire (EDE-Q) global score.
Time Frame
Baseline, 6 weeks, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Quality of Life Scores
Description
Change in quality of life scores among participants will be evaluated using the Pediatric Quality of Life Short Form (PedsQL 4.0).
Time Frame
Baseline, 6 weeks, 3 months, 6 months
Title
Utilization/Uptake of Treatment
Description
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).
Time Frame
Baseline, 6 weeks, 3 months, and 6 months
Other Pre-specified Outcome Measures:
Title
Depression Symptoms
Description
Change in depression symptoms as evaluated by the Pediatric Health Questionnaire for Adolescents (PHQ-A).
Time Frame
Baseline, 6 weeks, 3 months, 6 months
Title
Anxiety Symptoms
Description
Change in depression symptoms as evaluated by the Screen for Child Anxiety Related Disorders (SCARED).
Time Frame
Baseline, 6 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
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