NCT04806165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

March 11, 2021

Results QC Date

May 24, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening

    Treatment utilization was measured at each follow-up time point (2, 6, and 14 weeks), which was assessed via the prompt, "Have you tried or used any type of mental health help (e.g., self-help app, telehealth/in-person counseling, etc.) for your concerns related to your eating, shape, or weight in the past \[2, 6, or 14\] weeks?". We defined a participant as having utilized treatment at the first time they responded, "yes" (vs. "no") to this question. The data presented below indicate the rates of self-reported receipt of treatment/services utilization among participants assigned (component on) or not assigned (component off) to each of the four chatbot components (motivational interviewing, psychoeducation, personalized recommendations, repeated administration), as delineated by each time point during which the aforementioned item was assesed.

    2, 6, 14 Weeks from Engagement with the Intervention

Secondary Outcomes (2)

  • Mean Willingness to Seek Psychotherapy

    Baseline, 2 Weeks, 6 Weeks, 14 Weeks

  • 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

    Baseline, 2 weeks, 6 weeks, 14 weeks

Study Arms (16)

Repeated Administration

EXPERIMENTAL
Behavioral: Repeated Administration

Personalized Recommendation

EXPERIMENTAL
Behavioral: Personalized Recommendation

Motivational Interviewing

EXPERIMENTAL
Behavioral: Motivational Interviewing

Core Modules Only

EXPERIMENTAL
Behavioral: Core Modules Only

Motivational Interviewing, Personalized Recommendation, Repeated Administration

EXPERIMENTAL
Behavioral: Motivational Interviewing, Personalized Recommendation, Repeated Administration

Motivational Interviewing, Repeated Administration

EXPERIMENTAL
Behavioral: Motivational Interviewing, Repeated Administration

Motivational Interviewing, Personalized Recommendation

EXPERIMENTAL
Behavioral: Motivational Interviewing, Personalized Recommendation

Personalized Recommendation, Repeated Administration

EXPERIMENTAL
Behavioral: Personalized Recommendation, Repeated Administration

Psychoeducation

EXPERIMENTAL
Behavioral: Psychoeducation

Psychoeducation, Repeated Administration

EXPERIMENTAL
Behavioral: Psychoeducation, Repeated Administration

Psychoeducation, Personalized Recommendation

EXPERIMENTAL
Behavioral: Psychoeducation, Personalized Recommendation

Psychoeducation, Motivational Interviewing

EXPERIMENTAL
Behavioral: Psychoeducation, Motivational Interviewing

Psychoeducation, Motivational Interviewing, Personalized Recommendation

EXPERIMENTAL
Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation

Psychoeducation, Personalized Recommendation, Repeated Administration

EXPERIMENTAL
Behavioral: Psychoeducation, Personalized Recommendation, Repeated Administration

Psychoeducation, Motivational Interviewing, Repeated Administration

EXPERIMENTAL
Behavioral: Psychoeducation, Motivational Interviewing, Repeated Administration

Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration

EXPERIMENTAL
Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration

Interventions

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

Repeated Administration

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

Personalized Recommendation

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

Motivational Interviewing

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

Core Modules Only

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, Personalized Recommendation, 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.

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 identifying a personalized recommendation for accessing help for their eating disorder.

Motivational Interviewing, Personalized Recommendation

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.

Personalized Recommendation, Repeated Administration
PsychoeducationBEHAVIORAL

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

Psychoeducation

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, Repeated Administration

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, Personalized Recommendation

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

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, Motivational Interviewing, Personalized Recommendation

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, 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, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.

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, 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, Personalized Recommendation, Repeated Administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Ellen E. Fitzsimmons-Craft
Organization
Washington University in St. Louis School of Medicine

Study Officials

  • Ellen E Fitzsimmons-Craft, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 19, 2021

Study Start

March 9, 2021

Primary Completion

March 9, 2022

Study Completion

May 9, 2022

Last Updated

October 11, 2023

Results First Posted

October 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations