Clinical trial NCT04636840: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eating Disorders
Keywords: mHealth
eating disorders
bulimia nervosa
binge eating disorder
teens
adolescents
social media
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: SilverCloud Health
name: Palo Alto University
First posted: 2020-11-19
Enrollment: 161
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Eating Disorder Symptoms
timeFrame: Baseline, 6 weeks, 3 months, 6 months
Secondary outcomes:
measure: Quality of Life Scores
timeFrame: Baseline, 6 weeks, 3 months, 6 months
measure: Utilization/Uptake of Treatment
timeFrame: Baseline, 6 weeks, 3 months, and 6 months
Other outcomes:
measure: Depression Symptoms
timeFrame: Baseline, 6 weeks, 3 months, 6 months
measure: Anxiety Symptoms
timeFrame: Baseline, 6 weeks, 3 months, 6 months
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: