Treatment Uptake Chatbot for Eating Disorders

NCT ID: NCT04806165

Last Updated: 2023-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2022-05-09

Brief Summary

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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.

Detailed Description

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Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Repeated Administration

Group Type EXPERIMENTAL

Repeated Administration

Intervention Type BEHAVIORAL

A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.

Personalized Recommendation

Group Type EXPERIMENTAL

Personalized Recommendation

Intervention Type BEHAVIORAL

A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.

Motivational Interviewing

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.

Core Modules Only

Group Type EXPERIMENTAL

Core Modules Only

Intervention Type BEHAVIORAL

A discussion with the chatbot, including only the core modules.

Motivational Interviewing, Personalized Recommendation, Repeated Administration

Group Type EXPERIMENTAL

Motivational Interviewing, Personalized Recommendation, Repeated Administration

Intervention Type BEHAVIORAL

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.

Motivational Interviewing, Repeated Administration

Group Type EXPERIMENTAL

Motivational Interviewing, Repeated Administration

Intervention Type BEHAVIORAL

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.

Motivational Interviewing, Personalized Recommendation

Group Type EXPERIMENTAL

Motivational Interviewing, Personalized Recommendation

Intervention Type BEHAVIORAL

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.

Personalized Recommendation, Repeated Administration

Group Type EXPERIMENTAL

Personalized Recommendation, Repeated Administration

Intervention Type BEHAVIORAL

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.

Psychoeducation

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.

Psychoeducation, Repeated Administration

Group Type EXPERIMENTAL

Psychoeducation, Repeated Administration

Intervention Type BEHAVIORAL

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.

Psychoeducation, Personalized Recommendation

Group Type EXPERIMENTAL

Psychoeducation, Personalized Recommendation

Intervention Type BEHAVIORAL

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.

Psychoeducation, Motivational Interviewing

Group Type EXPERIMENTAL

Psychoeducation, Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Psychoeducation, Motivational Interviewing, Personalized Recommendation

Group Type EXPERIMENTAL

Psychoeducation, Motivational Interviewing, Personalized Recommendation

Intervention Type BEHAVIORAL

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.

Psychoeducation, Personalized Recommendation, Repeated Administration

Group Type EXPERIMENTAL

Psychoeducation, Personalized Recommendation, Repeated Administration

Intervention Type BEHAVIORAL

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.

Psychoeducation, Motivational Interviewing, Repeated Administration

Group Type EXPERIMENTAL

Psychoeducation, Motivational Interviewing, Repeated Administration

Intervention Type BEHAVIORAL

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.

Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration

Group Type EXPERIMENTAL

Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration

Intervention Type BEHAVIORAL

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.

Interventions

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Repeated Administration

A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.

Intervention Type BEHAVIORAL

Personalized Recommendation

A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.

Intervention Type BEHAVIORAL

Motivational Interviewing

A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.

Intervention Type BEHAVIORAL

Core Modules Only

A discussion with the chatbot, including only the core modules.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Psychoeducation

A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen E Fitzsimmons-Craft, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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K08MH120341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202007008

Identifier Type: -

Identifier Source: org_study_id

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