Clinical trial NCT04806165: Treatment Uptake Chatbot for Eating Disorders
Official title: Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-03-19
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Eating disorders (EDs) are serious mental illnesses associated with high morbidity and mortality, clinical impairment, and comorbid psychopathology. Although evidence-based treatments for EDs have been established, the treatment gap is wide. Indeed, \<20% of individuals with EDs receive treatment. There is need for a novel solution not only to identify individuals with EDs but also to encourage mental health services use and to address treatment barriers. This study aims to implement a conversational agent or "chatbot" that is optimized to increase mental health services use among individuals with EDs through such features as: 1) education on the seriousness and consequences of EDs; 2) engaging the user in motivational interviewing to overcome barriers to care; 3) providing a personalized recommendation for seeking intervention; 4) repeated check-ins with the user to encourage follow-up with care. This study will utilize a randomized optimization trial with adults who have completed screening on the National Eating Disorders Association (NEDA) website and screen positive for an ED but are not in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot on motivation for treatment and mental health services use. This trial will employ the Multiphase Optimization Strategy framework, using a 2\^4 full factorial design, to randomly assign participants to a combination of the four proposed intervention components (n=16 conditions) to isolate the active ingredients.


Eligibility criteria: Inclusion Criteria:

* U.S. resident
* English-speaking
* Age 18 years or older
* Owns a personal smartphone
* Screens positive for a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) clinical or subclinical eating disorder
* Not currently receiving treatment for an eating disorder

Exclusion Criteria:

* Non-U.S. resident
* Younger than 18 years old
* Does not own a personal smartphone
* Does not screen positive for a DSM-5 clinical or subclinical eating disorder
* Screens positive for Avoidant Restrictive Food Intake Disorder
* Currently receiving treatment for an eating disorder

Primary outcomes:
measure: Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening
timeFrame: 2, 6, 14 Weeks from Engagement with the Intervention
Secondary outcomes:
measure: Mean Willingness to Seek Psychotherapy
timeFrame: Baseline, 2 Weeks, 6 Weeks, 14 Weeks
measure: Mean Attitude Toward Change for Concerns Related to Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening
timeFrame: Baseline, 2 weeks, 6 weeks, 14 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ellen E Fitzsimmons-Craft, PhD
role: PRINCIPAL_INVESTIGATOR
References: