Eating Disorder Chatbot Optimization
ConditionEating Disorders
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18+ years old
Owns a smartphone
Speaks English
US resident
Disqualifiers
Below 18 years of age
Does not own a smartphone
Does not speak English
Lives outside the US
Trial design
Design model
Factorial
Treatments tested in this trial
Digital Chatbot Program
BehavioralWysa 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.
Treatment groups
800 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Chatbot targeting weight & shape over-evaluation (WSC)Experimental treatment 1 intervention
Group B: Chatbot targeting dietary restraint (DR)Experimental treatment 1 intervention
Group C: Chatbot targeting emotion dysregulation (ED)Experimental treatment 1 intervention
Group D: Chatbot targeting resisting urges to binge (UB)Experimental treatment 1 intervention
Group E: Chatbot targeting WSC and DRExperimental treatment 1 intervention
Group F: Chatbot targeting WSC and EDExperimental treatment 1 intervention
Group G: Chatbot targeting WSC and UBExperimental treatment 1 intervention
Group H: Chatbot targeting DR and EDExperimental treatment 1 intervention
Group I: Chatbot targeting DR and UBExperimental treatment 1 intervention
Group J: Chatbot targeting ED and UBExperimental treatment 1 intervention
Group K: Chatbot targeting ED; UB; and DRExperimental treatment 1 intervention
Group L: Chatbot targeting ED; UB; and WSCExperimental treatment 1 intervention
Group M: Chatbot targeting ED; DR; and WSCExperimental treatment 1 intervention
Group N: Chatbot targeting UB; DR; and WSCExperimental treatment 1 intervention
Group O: Chatbot targeting UB; DR; ED; and WSCExperimental treatment 1 intervention
Group P: Referral to seek servicesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
ED psychopathology; ED Examination-Questionnaire (EDE-Q)
The EDE-Q is a 28-item inventory derived from an ED diagnostic interview, which asks self-reported concerns with weight and shape, and engagement in ED behaviors, over the last 28 days. Each item is scored from 0-6, with 0 being "No days" and 6 being "Every day". An average is taken of all items participants respond to for a total global score (with possible scores ranging from 0 to 6), where higher scores indicate greater symptomology.
Time frame
6 monthsSecondary outcomes
1
ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI)
The EDE-Q will also be used to gauge self-reported engagement in ED behaviors. Additionally, the EPSI Muscle Building subscale will be used which is a 5-item questionnaire that asks self-reported frequency of muscle building behaviors and attitudes over the last 28 days. Each item is scored from 0 ("Never") to 4 ("Very Often"). Subscale score is calculated by summing items participants respond to (scores may range from 0 to 20), and higher scores indicate greater symptomology.
Time frame
6 months2
Depression; Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item scale asking about self-reported depressive symptoms and suicidality over the past two weeks. All items are scored from 0 ("Not at all") to 3 ("Nearly every day"). Items participants respond to are summed (possible scores ranging from 0 to 27), and higher scores indicate greater symptomology.
Time frame
6 months3
Anxiety; Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a 7-item scale assessing self-reported symptoms of anxiety over the past two weeks. All items are scored from 0 ("Not at all") to 3 ("Nearly every day"). Items participants respond to are summed (possible scores ranging from 0 to 21), and higher scores indicate greater symptomology.
Time frame
6 months4
Clinical Impairment; Clinical Impairment Assessment (CIA)
The CIA is a 16-item measure that assesses self-reported impairment, or impact on one's life, resulting from eating, weight, or shape in the last 28 days. All items are scores from 0 ("Not at all") to 3 ("A lot"). Items participants respond to are summed (possible scores ranging from 0 to 48), and higher scores indicate greater impairment.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
New York University
Collaborator
University of South Carolina
Collaborator
Source ClinicalTrials.gov