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Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention

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ClinicalTrials.gov Identifier: NCT04636840
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
SilverCloud Health
Palo Alto University
Information provided by (Responsible Party):
Washington University School of Medicine

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 and coach-led weekly group sessions. This mHealth intervention will be investigated among 150 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 (standard referral to care), a group with access to the mobile app only, and a group with access to the mobile app plus social networking feature. We hypothesized that those with access to the 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.

Condition or disease Intervention/treatment Phase
Eating Disorders Device: Space From Body and Eating Concerns- Teen Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
No Intervention: Control Group
Care as usual-referral to nationwide resources for eating disorders (NEDA)
Experimental: Experiemental Group A- Mobile App with Social Networking Feature
Access to Space From Body and Eating Concerns program on SilverCloud Health App in addition to access to Private Facebook group for social networking support.
Device: Space From Body and Eating Concerns- Teen
Self-guided mobile application to support eating disorder recovery efforts

Experimental: Experimental Group B- Mobile App Only
Access to Space From Body and Eating Concerns program on SilverCloud Health App.
Device: Space From Body and Eating Concerns- Teen
Self-guided mobile application to support eating disorder recovery efforts




Primary Outcome Measures :
  1. Weight/Shape Concerns [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Reduction in weight/shape concerns as evaluated by the Weight Concerns Scale (WCS).

  2. Dietary Restraint [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Improvements in dietary restrain as evaluated by the Three Factor Eating Disorder Questionnaire.

  3. Eating Disorder Symptoms [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Reduction of eating disorder symptoms as evaluated by the Eating Disorders Examination Questionnaire (EDE-Q).


Secondary Outcome Measures :
  1. Depression Symptom Reduction [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Reduction in depression symptoms as evaluated by the Pediatric Health Questionnaire for Adolescents (PHQ-A).

  2. Anxiety Symptom Reduction [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Reduction in depression symptoms as evaluated by the Screen for Child Anxiety Related Disorders (SCARED).

  3. Quality of Life [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ]
    Improvements in functioning and quality of life among participants will be evaluated using the Pediatric Quality of Life Short Form (PedsQL 4.0).



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Endorse at least 6 episodes of binge eating, vomiting, and/or laxative/diuretic use in the past 3 months

Exclusion Criteria:

  • Currently Engaged in eating disorder treatment
  • Screen Positive for Anorexia Nervosa
  • Wards of the State or Foster Children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636840


Contacts
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Contact: Patricia A Cavazos-Rehg, PhD 314-362-2152 pcavazos@wustl.edu
Contact: Erin M Kasson, MSW 314-362-9003 erinmkasson@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Patricia A Cavazos-Rehg, PhD    314-362-2152    pcavazos@wustl.edu   
Contact: Erin Kasson, MSW    314-362-9003    erinmkasson@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
SilverCloud Health
Palo Alto University
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04636840    
Other Study ID Numbers: 1R34MH119170-01 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be deidentified and uploaded into data sharing structures on the NIMH Data Archive as compliant with funding source requirements.
Time Frame: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.
Access Criteria: Summary data will be available on NIMH Data Archive as compliant with funding source requirements.

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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
Keywords provided by Washington University School of Medicine:
mHealth
eating disorders
bulimia nervosa
binge eating disorder
teens
adolescents
social media
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders