Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT04636840
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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Notify Me14 year–17 year
All sexes
Interventional
Phase 1
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mobile application with coaching component
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.
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).
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.
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.
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.
Washington University School of Medicine
Other
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