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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| SilverCloud Health | UNKNOWN |
| Palo Alto University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App | |
| Experimental Group A- Mobile App with Social Networking Feature | Experimental | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support. |
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| Experimental Group B- Mobile App Only | Experimental | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Space From Body and Eating Concerns- Teen | Device | Mobile application with coaching component |
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| Measure | Description | Time Frame |
|---|---|---|
| Eating Disorder Psychopathology | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Scores | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptoms | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
All data will be deidentified and uploaded into data sharing structures on the NIMH Data Archive as compliant with funding source requirements.
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Summary data will be available on NIMH Data Archive as compliant with funding source requirements.
Summary data will be available on NIMH Data Archive as compliant with funding source requirements.
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A total of 161 participants started their baseline survey. 13 did not complete their baseline survey and were not enrolled or assigned to a trial arm.
Participants were recruited using 1) social media advertisements, 2) National Eating Disorder Association (NEDA) online screen. Eligible individuals who completed online screens were sent a link to an online assent form and continued on to complete the baseline survey. 161 participants started their baseline survey, and 148 completed their baseline survey and were randomized into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Experimental Group B- Mobile App Only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2022 |
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| Total Time Spent on the App | Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds. | 3 months |
| Baseline, 6 weeks, 3 months, 6 months |
| Anxiety Symptoms | 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 |
Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App. |
| FG002 | Control Group | Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App |
| Completed 6 Week Survey |
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| Completed 3 Month Survey |
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| Completed 6 Month Survey |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Experimental Group B- Mobile App Only | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App. |
| BG002 | Control Group | Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age assessed at baseline of the study | All randomized participants were included in this baseline measure; the N shown in the row matches the overall sample size. | Mean | Standard Deviation | year |
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| Sex/Gender, Customized | What was your assigned sex at birth? - Male vs. Female v. Intersex | Includes participants with non-missing responses to "assigned sex at birth." Participants who did not answer this item were excluded from the row counts; therefore, the total analyzed for this measure is smaller than the overall study N. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Self-reported race and ethnicity were collected at baseline using standard categories. Participants selected the category that best described them. | Count of Participants | Participants |
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| BMI | Body Mass Index | Mean | Standard Deviation | Kg/M^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Eating Disorder Psychopathology | 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. | Analyses followed the intention-to-treat principle. The numbers analyzed represent all randomized participants in each arm, regardless of adherence to the assigned intervention. | Posted | Mean | Standard Deviation | EDE-Q Global score | Baseline, 6 weeks, 3 months, 6 months |
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| Secondary | Quality of Life Scores | 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). | The numbers analyzed represent participants who provided outcome data at all required assessment time points (baseline, 6 weeks, 3 months, 6 months). Participants missing one or more assessments were excluded; therefore, Ns may be smaller than the numbers assigned. | Posted | Mean | Standard Deviation | A total score on a scale (0 to 100) | Baseline, 6 weeks, 3 months, 6 months |
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| Secondary | Total Time Spent on the App | Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds. | We reported medians (interquartile ranges) of total time spent on the app among participants who logged in at least once during the study period. | Posted | Median | Inter-Quartile Range | Second | 3 months |
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| Other Pre-specified | Depression Symptoms | 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. | Posted | Mean | Standard Deviation | Scores range from 0 to 24 | Baseline, 6 weeks, 3 months, 6 months |
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| Other Pre-specified | Anxiety Symptoms | 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. | Analyses followed the intention-to-treat principle. The numbers analyzed represent all randomized participants in each arm, regardless of adherence to the assigned intervention. | Posted | Mean | Standard Deviation | A total score on a scale (0 to 82) | Baseline, 6 weeks, 3 months, 6 months |
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Adverse event data were collected for up to 6 months following baseline assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG001 | Experimental Group B- Mobile App Only | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG002 | Control Group | Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App | 0 | 49 | 0 | 49 | 0 | 49 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Cavazos-Rehg | Washington University School of Medicine | 314-362-2152 | pcavazos@wustl.edu |
| Jan 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D052018 | Bulimia Nervosa |
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Male |
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| Intersex |
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| Non-Hispanic Black |
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| Hispanic |
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| Other/Multiple races |
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| 3-Month follow-up (end of intervention) |
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| 6-Month follow-up (3-Month post intervention) |
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| Superiority |
| We used alinear mixed effects model with change in the measures from baseline as the dependent variable and the baseline assessment used as a covariate. A random intercept for individuals was included in the models to account for the correlation of within-subject measurements over time. Models included fixed effects of intervention conditions and time. The time variable was treated as a continuous variable (e.g., 6, 12, 24). The control group served as a reference group. | Mixed Models Analysis | The model included a random intercept for individuals, fixed effects of intervention conditions, and time (e.g., 0, 6, 12, and 24). | 0.91 | Slope | -0.03 | 2-Sided | 95 | -0.46 | 0.40 | Superiority |
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