Treatment Uptake Chatbot for Eating Disorders

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04806165

Collaborator

National Institute of Mental Health (NIMH) (NIH)

206

Enrollment

Location

Arms

Actual Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders	Behavioral: Repeated Administration Behavioral: Personalized Recommendation Behavioral: Motivational Interviewing Behavioral: Core Modules Only Behavioral: Motivational Interviewing, Personalized Recommendation, Repeated Administration Behavioral: Motivational Interviewing, Repeated Administration Behavioral: Motivational Interviewing, Personalized Recommendation Behavioral: Personalized Recommendation, Repeated Administration Behavioral: Psychoeducation Behavioral: Psychoeducation, Repeated Administration Behavioral: Psychoeducation, Personalized Recommendation Behavioral: Psychoeducation, Motivational Interviewing Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation Behavioral: Psychoeducation, Personalized Recommendation, Repeated Administration Behavioral: Psychoeducation, Motivational Interviewing, Repeated Administration Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders

Actual Study Start Date :

Mar 9, 2021

Actual Primary Completion Date :

Mar 9, 2022

Actual Study Completion Date :

May 9, 2022

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Number of participants who report receipt of any type of mental health help for eating, shape, or weight concerns [14 weeks]
Self-report receipt of mental health help for eating, shape, or weight concerns.
Change in motivation (comprised of importance and readiness) to change and seek help for eating, shape, or weight concerns, as well as willingness to seek help [Baseline, 2 weeks, 6 weeks, 14 weeks]
Likert scale (1-7) items

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Ellen E Fitzsimmons-Craft, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT04806165

Other Study ID Numbers:

202007008
K08MH120341

First Posted:

Mar 19, 2021

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Feeding and Eating Disorders

Study Results

No Results Posted as of Jul 1, 2022

Arm	Intervention/Treatment
Experimental: Repeated Administration	Behavioral: Repeated Administration A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Personalized Recommendation	Behavioral: Personalized Recommendation A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.
Experimental: Motivational Interviewing	Behavioral: Motivational Interviewing A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
Experimental: Core Modules Only	Behavioral: Core Modules Only A discussion with the chatbot, including only the core modules.
Experimental: Motivational Interviewing, Personalized Recommendation, Repeated Administration	Behavioral: Motivational Interviewing, Personalized Recommendation, Repeated Administration A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Motivational Interviewing, Repeated Administration	Behavioral: Motivational Interviewing, Repeated Administration A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Motivational Interviewing, Personalized Recommendation	Behavioral: Motivational Interviewing, Personalized Recommendation A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder.
Experimental: Personalized Recommendation, Repeated Administration	Behavioral: Personalized Recommendation, Repeated Administration A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Psychoeducation	Behavioral: Psychoeducation A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.
Experimental: Psychoeducation, Repeated Administration	Behavioral: Psychoeducation, Repeated Administration A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Psychoeducation, Personalized Recommendation	Behavioral: Psychoeducation, Personalized Recommendation A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder.
Experimental: Psychoeducation, Motivational Interviewing	Behavioral: Psychoeducation, Motivational Interviewing A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
Experimental: Psychoeducation, Motivational Interviewing, Personalized Recommendation	Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder.
Experimental: Psychoeducation, Personalized Recommendation, Repeated Administration	Behavioral: Psychoeducation, Personalized Recommendation, Repeated Administration A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Psychoeducation, Motivational Interviewing, Repeated Administration	Behavioral: Psychoeducation, Motivational Interviewing, Repeated Administration A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Experimental: Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration	Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.