Digital Chatbot for Eating Disorders

NA
MB
Overseen ByMarianna B. Horton, B.S./B.A.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital chatbot program designed to assist individuals with eating disorders. It explores various approaches to aid emotional regulation, resist binge urges, manage dietary restraint, and address concerns about weight and shape. Participants are divided into groups to test different chatbot features. This study is suitable for U.S. residents who have a smartphone, speak English, and have an eating disorder diagnosis but are not currently receiving treatment. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to the development of innovative support tools.

Will I have to stop taking my current medications?

If you are taking medications that affect your appetite or weight, you may not be eligible for this trial. The protocol does not specify if you need to stop other medications.

What prior data suggests that this digital chatbot program is safe for adults with eating disorders?

Research has shown that digital chatbots are generally safe for use, particularly in mental health care. A study on chatbots for eating disorders aims to enhance their effectiveness in managing emotions, controlling diet, and addressing body image concerns. As a Phase 2 trial, the chatbot has already undergone safety testing in smaller groups. This phase emphasizes effectiveness rather than identifying new safety issues. Chatbots are typically well-received, with few reported problems. They are designed to offer support and guidance, making them a low-risk option for those considering trial participation.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these digital chatbot programs for eating disorders because they offer a unique, tech-based approach to addressing key aspects of the condition. Unlike traditional therapy that often requires in-person sessions, these chatbots provide 24/7 access, allowing participants to work on emotion regulation, dietary restraint, and resisting urges to binge whenever they need. This immediate accessibility and personalized practice could lead to more consistent engagement and potentially faster improvements. Additionally, the chatbot's ability to target specific components like weight and shape over-evaluation offers a tailored experience that can adapt to individual needs, setting it apart from more generalized treatment options.

What evidence suggests that this trial's digital chatbot program could be effective for eating disorders?

Studies have shown that digital chatbots can effectively help with eating disorder symptoms. In this trial, participants will engage with different chatbot components targeting specific challenges such as controlling emotions, resisting the urge to binge eat, and maintaining healthy eating habits. Research indicates that these chatbots assist users in managing these challenges. Users have reported feeling better about their eating-related thoughts and behaviors after using these tools. Initial findings suggest that the chatbot's ability to offer immediate support and practice exercises helps manage eating disorder symptoms. Additionally, these chatbots provide a convenient and accessible way for people to engage with treatment whenever it suits them.13467

Who Is on the Research Team?

EF

Ellen Fitzsimmons-Craft, Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Adults over 18 living in the US with clinical or subclinical eating disorders can join this trial if they own a smartphone, speak English, and are not at high risk of suicide. They shouldn't be pregnant, in current treatment for an eating disorder, or have conditions/medications affecting appetite/weight.

Inclusion Criteria

I am 18 years old or older.
Owns a smartphone
Speaks English
See 6 more

Exclusion Criteria

Does not speak English
Does not own a smartphone
Lives outside the US
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to various chatbot components targeting different aspects of eating disorders, such as emotion dysregulation, dietary restraint, and resisting urges to binge.

6 months

Treatment

Participants receive access to various chatbot components targeting different aspects of eating disorders, such as emotion dysregulation, dietary restraint, and resisting urges to binge.

6 months
Continuous access to chatbot components

Follow-up

Participants are monitored for changes in ED psychopathology, ED behavior frequencies, comorbid symptoms, and clinical impairment.

6 months

Follow-up

Participants are monitored for changes in ED psychopathology, ED behavior frequencies, comorbid symptoms, and clinical impairment.

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Chatbot Program
Trial Overview The study is testing how well a digital chatbot program works to help adults with eating disorders like Anorexia nervosa. The goal is to make the chatbot better at supporting individuals who may struggle with these conditions.
How Is the Trial Designed?
16Treatment groups
Experimental Treatment
Active Control
Group I: Chatbot targeting weight & shape over-evaluation (WSC)Experimental Treatment1 Intervention
Group II: Chatbot targeting resisting urges to binge (UB)Experimental Treatment1 Intervention
Group III: Chatbot targeting emotion dysregulation (ED)Experimental Treatment1 Intervention
Group IV: Chatbot targeting dietary restraint (DR)Experimental Treatment1 Intervention
Group V: Chatbot targeting WSC and UBExperimental Treatment1 Intervention
Group VI: Chatbot targeting WSC and EDExperimental Treatment1 Intervention
Group VII: Chatbot targeting WSC and DRExperimental Treatment1 Intervention
Group VIII: Chatbot targeting UB; DR; and WSCExperimental Treatment1 Intervention
Group IX: Chatbot targeting UB; DR; ED; and WSCExperimental Treatment1 Intervention
Group X: Chatbot targeting ED; UB; and WSCExperimental Treatment1 Intervention
Group XI: Chatbot targeting ED; UB; and DRExperimental Treatment1 Intervention
Group XII: Chatbot targeting ED; DR; and WSCExperimental Treatment1 Intervention
Group XIII: Chatbot targeting ED and UBExperimental Treatment1 Intervention
Group XIV: Chatbot targeting DR and UBExperimental Treatment1 Intervention
Group XV: Chatbot targeting DR and EDExperimental Treatment1 Intervention
Group XVI: Referral to seek servicesActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

New York University

Collaborator

Trials
249
Recruited
229,000+

University of South Carolina

Collaborator

Trials
233
Recruited
122,000+

Citations

NCT07218302 | Eating Disorder Chatbot OptimizationIn this study the intervention will be divided into four components targeting: (1) over-evaluation of weight and shape; (2) dietary restraint; ( ...
Project DetailsThe goal of this study is to fill this gap by optimizing an automated chatbot program to treat EDs. We will build on our programmatic research in this area and ...
Eating Disorder Chatbot Optimization - ClinicalTrials.VeevaThe purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.
The Effectiveness of a Chatbot Single-Session Intervention ...This study aimed to investigate the effectiveness of an SSI delivered by ED ESSI. We examined the chatbot's impact on eating disorder pathology, psychosocial ...
Effect of ChatGPT use on eating disorders and body imageEffectiveness of a chatbot for eating disorders prevention: A randomized clinical trial. Int J Eat Disord. 2022;55:343-353. [RCA] [PubMed] ...
Project DetailsThe goal of this study is to fill this gap by optimizing an automated chatbot program to treat eating disorders, ultimately resulting in a infinitely scalable, ...
Review of machine learning solutions for eating disordersThis narrative review explores current Machine Learning (ML) and Artificial Intelligence (AI) applications in the domain of EDs, with a specific emphasis on ...
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