Eating DisordersNCT04806165
Treatment Uptake Chatbot for Eating Disorders
A study testing Repeated Administration, Personalized Recommendation and Motivational Interviewing in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Repeated Administration, Personalized Recommendation and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 9 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders
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.
- Conditions
- Eating Disorders
- Being tested
- Repeated Administration, Personalized Recommendation, Motivational Interviewing, Core Modules Only, Motivational Interviewing, Personalized Recommendation, Repeated Administration
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated AdministrationBehavioural
A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
Personalized RecommendationBehavioural
A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.
Motivational InterviewingBehavioural
A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
Core Modules OnlyBehavioural
A discussion with the chatbot, including only the core modules.
Motivational Interviewing, Personalized Recommendation, Repeated AdministrationBehavioural
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 AdministrationBehavioural
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 RecommendationBehavioural
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 AdministrationBehavioural
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.
PsychoeducationBehavioural
A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.
Psychoeducation, Repeated AdministrationBehavioural
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 RecommendationBehavioural
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 InterviewingBehavioural
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 RecommendationBehavioural
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 AdministrationBehavioural
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 AdministrationBehavioural
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 AdministrationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Repeated Administration | Experimental | Not described Receives: Behavioral: Repeated Administration |
| Personalized Recommendation | Experimental | Not described Receives: Behavioral: Personalized Recommendation |
| Motivational Interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
| Core Modules Only | Experimental | Not described Receives: Behavioral: Core Modules Only |
| Motivational Interviewing, Personalized Recommendation, Repeated Administration | Experimental | Not described Receives: Behavioral: Motivational Interviewing, Personalized Recommendation, Repeated Administration |
| Motivational Interviewing, Repeated Administration | Experimental | Not described Receives: Behavioral: Motivational Interviewing, Repeated Administration |
| Motivational Interviewing, Personalized Recommendation | Experimental | Not described Receives: Behavioral: Motivational Interviewing, Personalized Recommendation |
| Personalized Recommendation, Repeated Administration | Experimental | Not described Receives: Behavioral: Personalized Recommendation, Repeated Administration |
| Psychoeducation | Experimental | Not described Receives: Behavioral: Psychoeducation |
| Psychoeducation, Repeated Administration | Experimental | Not described Receives: Behavioral: Psychoeducation, Repeated Administration |
| Psychoeducation, Personalized Recommendation | Experimental | Not described Receives: Behavioral: Psychoeducation, Personalized Recommendation |
| Psychoeducation, Motivational Interviewing | Experimental | Not described Receives: Behavioral: Psychoeducation, Motivational Interviewing |
| Psychoeducation, Motivational Interviewing, Personalized Recommendation | Experimental | Not described Receives: Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation |
| Psychoeducation, Personalized Recommendation, Repeated Administration | Experimental | Not described Receives: Behavioral: Psychoeducation, Personalized Recommendation, Repeated Administration |
| Psychoeducation, Motivational Interviewing, Repeated Administration | Experimental | Not described Receives: Behavioral: Psychoeducation, Motivational Interviewing, Repeated Administration |
| Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Experimental | Not described Receives: Behavioral: Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 6, 14 Weeks from Engagement with the Intervention
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Baseline, 2 weeks, 6 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start9 Mar 2021
- Primary completion9 Mar 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ellen E Fitzsimmons-Craft, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806165
- Sponsor's protocol ID
- 202007008
- Other IDs
- K08MH120341
- Status last verified
- Sep 2023
- First submitted
- 11 Mar 2021
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fitzsimmons-Craft EE, Rackoff GN, Shah J, Strayhorn JC, D'Adamo L, DePietro B, Howe CP, Firebaugh ML, Newman MG, Collins LM, Taylor CB, Wilfley DE. Effects of Chatbot Components to Facilitate Mental Health Services Use in Individuals With Eating Disorders Following Online Screening: An Optimization Randomized Controlled Trial. Int J Eat Disord. 2024 Nov;57(11):2204-2216. doi: 10.1002/eat.24260. Epub 2024 Jul 28.
PubMed 39072846
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders
- ClinicalTrials.gov ID
- NCT04806165
- Acronym / sponsor ID
- 202007008
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated AdministrationA discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | Behavioural | Repeated Administration |
| Personalized RecommendationA discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder. | Behavioural | Personalized Recommendation |
| Motivational InterviewingA discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. | Behavioural | Motivational Interviewing |
| Core Modules OnlyA discussion with the chatbot, including only the core modules. | Behavioural | Core Modules Only |
| Motivational Interviewing, Personalized Recommendation, Repeated AdministrationA 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. | Behavioural | Motivational Interviewing, Personalized Recommendation, Repeated Administration |
| Motivational Interviewing, Repeated AdministrationA 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. | Behavioural | Motivational Interviewing, Repeated Administration |
| Motivational Interviewing, Personalized RecommendationA 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. | Behavioural | Motivational Interviewing, Personalized Recommendation |
| Personalized Recommendation, Repeated AdministrationA 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. | Behavioural | Personalized Recommendation, Repeated Administration |
| PsychoeducationA discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders. | Behavioural | Psychoeducation |
| Psychoeducation, Repeated AdministrationA 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. | Behavioural | Psychoeducation, Repeated Administration |
| Psychoeducation, Personalized RecommendationA 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. | Behavioural | Psychoeducation, Personalized Recommendation |
| Psychoeducation, Motivational InterviewingA 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. | Behavioural | Psychoeducation, Motivational Interviewing |
| Psychoeducation, Motivational Interviewing, Personalized RecommendationA 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. | Behavioural | Psychoeducation, Motivational Interviewing, Personalized Recommendation |
| Psychoeducation, Personalized Recommendation, Repeated AdministrationA 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. | Behavioural | Psychoeducation, Personalized Recommendation, Repeated Administration |
| Psychoeducation, Motivational Interviewing, Repeated AdministrationA 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. | Behavioural | Psychoeducation, Motivational Interviewing, Repeated Administration |
| Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated AdministrationA 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. | Behavioural | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration |
Primary outcome
Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening
Time frame: 2, 6, 14 Weeks from Engagement with the Intervention
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 secondary outcomes
Mean Willingness to Seek Psychotherapy
Time frame: 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
Time frame: Baseline, 2 weeks, 6 weeks, 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39072846Fitzsimmons-Craft EE, Rackoff GN, Shah J, Strayhorn JC, D'Adamo L, DePietro B, Howe CP, Firebaugh ML, Newman MG, Collins LM, Taylor CB, Wilfley DE. Effects of Chatbot Components to Facilitate Mental Health Services Use in Individuals With Eating Disorders Following Online Screening: An Optimization Randomized Controlled Trial. Int J Eat Disord. 2024 Nov;57(11):2204-2216. doi: 10.1002/eat.24260. Epub 2024 Jul 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen E Fitzsimmons-Craft, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated Administration, Personalized Recommendation and Motivational Interviewing in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening (time frame: 2, 6, 14 Weeks from Engagement with the Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.