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Treatment Uptake Chatbot for Eating Disorders

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repeated Administration
Personalized Recommendation
Motivational Interviewing
Core Modules Only
Motivational Interviewing, Personalized Recommendation, Repeated Administration
Motivational Interviewing, Repeated Administration
Motivational Interviewing, Personalized Recommendation
Personalized Recommendation, Repeated Administration
Psychoeducation
Psychoeducation, Repeated Administration
Psychoeducation, Personalized Recommendation
Psychoeducation, Motivational Interviewing
Psychoeducation, Motivational Interviewing, Personalized Recommendation
Psychoeducation, Personalized Recommendation, Repeated Administration
Psychoeducation, Motivational Interviewing, Repeated Administration
Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Repeated Administration

Personalized Recommendation

Motivational Interviewing

Core Modules Only

Motivational Interviewing, Personalized Recommendation, Repeated Administration

Motivational Interviewing, Repeated Administration

Motivational Interviewing, Personalized Recommendation

Personalized Recommendation, Repeated Administration

Psychoeducation

Psychoeducation, Repeated Administration

Psychoeducation, Personalized Recommendation

Psychoeducation, Motivational Interviewing

Psychoeducation, Motivational Interviewing, Personalized Recommendation

Psychoeducation, Personalized Recommendation, Repeated Administration

Psychoeducation, Motivational Interviewing, Repeated Administration

Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Willingness to Seek Psychotherapy
Participants' willingness to seek psychotherapy was assessed via an identical item in the baseline assessment (i.e., before the initial chatbot assessment) as well as each off the follow-up assessments delivered at 2, 6, and 14 weeks post-intervention. The item prompted users to rate their willingness to seek in-person or telehealth psychotherapy in subsequent weeks. Responses were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready). Mean values reported below indicate the average Likert scale willingness rating among all participants at each time point who did (component turned on) and did not (component turned off). Statistical analyses outline the time and component effects on changes in mean willingness to seek pyschotherapy from baseline to 14 weeks post-interventioon.
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
Participants' attitudes toward making changes (i.e., motivation toward seeking help) to address their personal eating, shape, and weight concerns were measured via identical items in the baseline assessment, and in each of the 2, 6, and 14 week follow-up assessments. Items included, "How important is it for you to change your eating, shape, or weight concerns?" and, "How ready are you to make changes in your eating, shape, or weight concerns?". Both items were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready), and the sum of the two questions was used as an index of change/motivation attitudes. Values below indicate the average Likert scale attitude rating (from 2 (lowest) to 14 (highest)) among all participants at each time point who did (component turned on) and did not (component turned off) receive each component. Analyses outline the time, component, and time by component interaction effects on changes in motivation attitudes since baseline.

Full Information

First Posted
March 11, 2021
Last Updated
September 18, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04806165
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repeated Administration
Arm Type
Experimental
Arm Title
Personalized Recommendation
Arm Type
Experimental
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Title
Core Modules Only
Arm Type
Experimental
Arm Title
Motivational Interviewing, Personalized Recommendation, Repeated Administration
Arm Type
Experimental
Arm Title
Motivational Interviewing, Repeated Administration
Arm Type
Experimental
Arm Title
Motivational Interviewing, Personalized Recommendation
Arm Type
Experimental
Arm Title
Personalized Recommendation, Repeated Administration
Arm Type
Experimental
Arm Title
Psychoeducation
Arm Type
Experimental
Arm Title
Psychoeducation, Repeated Administration
Arm Type
Experimental
Arm Title
Psychoeducation, Personalized Recommendation
Arm Type
Experimental
Arm Title
Psychoeducation, Motivational Interviewing
Arm Type
Experimental
Arm Title
Psychoeducation, Motivational Interviewing, Personalized Recommendation
Arm Type
Experimental
Arm Title
Psychoeducation, Personalized Recommendation, Repeated Administration
Arm Type
Experimental
Arm Title
Psychoeducation, Motivational Interviewing, Repeated Administration
Arm Type
Experimental
Arm Title
Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Repeated Administration
Intervention Description
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
Intervention Name(s)
Personalized Recommendation
Intervention Description
A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
Intervention Type
Behavioral
Intervention Name(s)
Core Modules Only
Intervention Description
A discussion with the chatbot, including only the core modules.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing, Personalized Recommendation, Repeated Administration
Intervention Description
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
Intervention Name(s)
Motivational Interviewing, Repeated Administration
Intervention Description
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
Intervention Name(s)
Motivational Interviewing, Personalized Recommendation
Intervention Description
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
Intervention Name(s)
Personalized Recommendation, Repeated Administration
Intervention Description
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
Intervention Name(s)
Psychoeducation
Intervention Description
A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation, Repeated Administration
Intervention Description
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
Intervention Name(s)
Psychoeducation, Personalized Recommendation
Intervention Description
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
Intervention Name(s)
Psychoeducation, Motivational Interviewing
Intervention Description
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
Intervention Name(s)
Psychoeducation, Motivational Interviewing, Personalized Recommendation
Intervention Description
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
Intervention Name(s)
Psychoeducation, Personalized Recommendation, Repeated Administration
Intervention Description
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
Intervention Name(s)
Psychoeducation, Motivational Interviewing, Repeated Administration
Intervention Description
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
Intervention Name(s)
Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening
Description
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.
Time Frame
2, 6, 14 Weeks from Engagement with the Intervention
Secondary Outcome Measure Information:
Title
Mean Willingness to Seek Psychotherapy
Description
Participants' willingness to seek psychotherapy was assessed via an identical item in the baseline assessment (i.e., before the initial chatbot assessment) as well as each off the follow-up assessments delivered at 2, 6, and 14 weeks post-intervention. The item prompted users to rate their willingness to seek in-person or telehealth psychotherapy in subsequent weeks. Responses were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready). Mean values reported below indicate the average Likert scale willingness rating among all participants at each time point who did (component turned on) and did not (component turned off). Statistical analyses outline the time and component effects on changes in mean willingness to seek pyschotherapy from baseline to 14 weeks post-interventioon.
Time Frame
Baseline, 2 Weeks, 6 Weeks, 14 Weeks
Title
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
Description
Participants' attitudes toward making changes (i.e., motivation toward seeking help) to address their personal eating, shape, and weight concerns were measured via identical items in the baseline assessment, and in each of the 2, 6, and 14 week follow-up assessments. Items included, "How important is it for you to change your eating, shape, or weight concerns?" and, "How ready are you to make changes in your eating, shape, or weight concerns?". Both items were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready), and the sum of the two questions was used as an index of change/motivation attitudes. Values below indicate the average Likert scale attitude rating (from 2 (lowest) to 14 (highest)) among all participants at each time point who did (component turned on) and did not (component turned off) receive each component. Analyses outline the time, component, and time by component interaction effects on changes in motivation attitudes since baseline.
Time Frame
Baseline, 2 weeks, 6 weeks, 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen E Fitzsimmons-Craft, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment Uptake Chatbot for Eating Disorders

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