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Purpose

The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Chatbot targeting weight & shape over-evaluation (WSC) 		Participant will have access to the chatbot component addressing weight & shape over-evaluation. Participant will receive scheduled targeted practice for the weight & shape over-evaluation component. At any time, participant will have access to initiate practice in assigned study component.
  • 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.
Experimental
Chatbot targeting dietary restraint (DR) 		Participant will have access to the chatbot component addressing dietary restraint. Participant will receive scheduled targeted practice for the dietary restraint component. At any time, participant will have access to initiate practice in assigned study component.
  • 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.
Experimental
Chatbot targeting emotion dysregulation (ED) 		Participant will have access to the chatbot component addressing emotion dysregulation. Participant will receive scheduled targeted practice for the emotion dysregulation component. At any time, participant will have access to initiate practice in assigned study component.
  • 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.
Experimental
Chatbot targeting resisting urges to binge (UB) 		Participant will have access to the chatbot component addressing resisting urges to binge. Participant will receive scheduled targeted practice for the resisting urges to binge component. At any time, participant will have access to initiate practice in assigned study component.
  • 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.
Experimental
Chatbot targeting WSC and DR 		Participant will have access to the chatbot components addressing weight & shape over-evaluation and dietary restraint. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting WSC and ED 		Participant will have access to the chatbot components addressing weight & shape over-evaluation and emotion deregulation. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting WSC and UB 		Participant will have access to the chatbot components addressing weight & shape over-evaluation and resisting urges to binge. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting DR and ED 		Participant will have access to the chatbot components addressing dietary restraint and emotion deregulation. Participant will receive scheduled targeted practice for the dietary restraint and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting DR and UB 		Participant will have access to the chatbot components addressing dietary restraint and resisting urges to binge. Participant will receive scheduled targeted practice for the dietary restraint and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting ED and UB 		Participant will have access to the chatbot components addressing emotion dysregulation and resisting urges to binge. Participant will receive scheduled targeted practice for the emotion dysregulation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting ED; UB; and DR 		Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and dietary restraint. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting ED; UB; and WSC 		Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting ED; DR; and WSC 		Participant will have access to the chatbot components addressing emotion dysregulation, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, dietary restraint, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
Experimental
Chatbot targeting UB; DR; and WSC 		Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint and weight, and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components
  • 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.
Experimental
Chatbot targeting UB; DR; ED; and WSC 		Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, emotion dysregulation, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint, emotion dysregulation, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
  • 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.
No Intervention
Referral to seek services 		Those randomized to receive all chatbot components "off" will receive a referral to seek services.

Recruiting Locations

Washington University in St. Louis
St Louis, Missouri 63105
Contact:
Marianna B. Horton, B.S./B.A.
3149355843
m.horton@wustl.edu

More Details

Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Marianna B. Horton, B.S./B.A.
3149355843
m.horton@wustl.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.