Eating Disorder Chatbot Optimization
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Digital Chatbot Program.
- Кому может быть актуально
- Состояния в реестре: Eating Disorders. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Optimizing an Automated Chatbot to Achieve Efficient, Scalable Treatment for Eating Disorders
Обзор
The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.
Подробное описание
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.
Вмешательства
- Поведенческое 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.
Первичные конечные точки
- ED psychopathology; ED Examination-Questionnaire (EDE-Q) [Срок оценки: 6 months]
Вторичные конечные точки (4)
- ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI) [Срок оценки: 6 months]
- Depression; Patient Health Questionnaire (PHQ-9) [Срок оценки: 6 months]
- Anxiety; Generalized Anxiety Disorder (GAD-7) [Срок оценки: 6 months]
- Clinical Impairment; Clinical Impairment Assessment (CIA) [Срок оценки: 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Washington University in St. Louis — St Louis
Идентификаторы
NCT: NCT07218302 · 202505037