Eating Disorders
Conditions
Keywords
mHealth, eating disorders, bulimia nervosa, binge eating disorder, teens, adolescents, social media
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.
Interventions
DEVICESpace From Body and Eating Concerns- Teen
Mobile application with coaching component
Sponsors
Washington University School of Medicine
National Institute of Mental Health (NIMH)
SilverCloud Health
Palo Alto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Psychopathology | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scores | 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). |
| Total Time Spent on the App | 3 months | Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 16.09 year STANDARD_DEVIATION 0.9 |
| BMI | 26.40 Kg/M^2 STANDARD_DEVIATION 6.42 |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 9 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic Black | 7 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic White | 69 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Other/Multiple races | 13 Participants |
| Sex/Gender, Customized Sex assigned at birth Female | 43 Participants |
| Sex/Gender, Customized Sex assigned at birth Intersex | 0 Participants |
| Sex/Gender, Customized Sex assigned at birth Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 48 | 0 / 49 |
| other Total, other adverse events | 0 / 51 | 0 / 48 | 0 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 | 0 / 49 |
Outcome results
None listed