Eating Disorder Chatbot Optimization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Chatbot Program.
- Who it may be relevant to
- Registry conditions: Eating Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimizing an Automated Chatbot to Achieve Efficient, Scalable Treatment for Eating Disorders
Overview
The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.
Detailed description
Eating disorders (EDs) are common-affecting an estimated 10% of individuals in their lifetimes-and have disabling consequences being associated with high psychiatric comorbidity, impairment, and mortality. Despite this, less than 20% of individuals with an ED ever receive treatment. When individuals do seek treatment, many are not evidence-based and come with high costs and burden on the healthcare system. One solution to this is a chatbot intervention that is evidence-based, affordable, and accessible for people with EDs. This project will assess four candidate components of a cognitive behavioral therapy (CBT)-based chatbot to determine the optimal chatbot package. CBT is the recommended first-line treatment for EDs, yet there is no research to date on which components are most effective or needed for meaningful change in ED psychopathology. In this study the intervention will be divided into four components targeting: (1) over-evaluation of weight and shape; (2) dietary restraint; (3) emotion dysregulation; and (4) resisting urges to binge. The investigators will recruit 800 adults with a binge/purge-type ED who are not currently in treatment and randomly assign participants to one of 16 experimental conditions (each combination from 1 to all 4 components) or the waitlist-control group. Participants will be assessed on changes in ED psychopathology, ED behavior frequencies, comorbid symptoms (i.e., depression, anxiety), and clinical impairment at 1-, 2-, and 6-months following randomization. An optimized package of these candidate components that is most effective, while remaining efficient, will be identified using multiphase optimization strategy (MOST). The investigators' established relationships with industry and non-profit partners will ensure this optimized package has high potential for scalability and dissemination into the community.
Interventions
- Behavioral Digital Chatbot Program
Wysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules. Participants in an arm with access to Wysa will engage with the digital chatbot program daily for eight weeks.
Primary outcome measures
- ED psychopathology; ED Examination-Questionnaire (EDE-Q) [Time frame: 6 months]
Secondary outcome measures (4)
- ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI) [Time frame: 6 months]
- Depression; Patient Health Questionnaire (PHQ-9) [Time frame: 6 months]
- Anxiety; Generalized Anxiety Disorder (GAD-7) [Time frame: 6 months]
- Clinical Impairment; Clinical Impairment Assessment (CIA) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 18+ years old
- Owns a smartphone
- Speaks English
- US resident
- Screens for a clinical or subclinical eating disorder
- Low suicidality
- Not currently in treatment for an eating disorder
- Does not have a medical condition or take medications that impact appetite/weight
- Not currently pregnant
Exclusion criteria
- Below 18 years of age
- Does not own a smartphone
- Does not speak English
- Lives outside the US
- Screens as: at risk for an eating disorder, anorexia nervosa, atypical anorexia nervosa, avoidant/restrictive food intake disorder, or not at risk for an ED
- High suicidality
- In treatment for an eating disorder
- Has a medical condition or takes medication(s) that impact appetite/weight
- Currently pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University in St. Louis — St Louis
Identifiers
NCT: NCT07218302 · 202505037