Идёт набор NCT07237607

Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders

Без фазы С лечением Eating Disorders Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder

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: "Exp-ED" Digital Exposure-Therapy Chatbot app.
Кому может быть актуально: Состояния в реестре: Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder. Базовые параметры: 12 лет — 26 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

Developing an Artificial Intelligence (AI)-Powered Exposure Therapy Chatbot for Adolescents and Young Adults With Eating Disorders

Обзор

The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.

Подробное описание

The overarching goal of this study is to develop and refine an AI-powered Exposure Therapy for Eating Disorders (Exp-ED) chatbot app that effectively engages adolescents and young adults (AYAs) with eating disorders (EDs) and decreases anxiety about weight gain. The investigators will enroll 20 AYAs (ages 12-26 years) entering the Partial Hospitalization Program (PHP) for EDs at the Penn State Milton S. Hershey Medical Center. The initial version of the Exp-ED chatbot app will be developed by an interdisciplinary team with expertise in exposure therapy for EDs (Dr. Essayli), AI (Dr. Nawab), and implementation science (Dr. Lenker). Participants will use the Exp-ED chatbot app as a supplemental therapeutic tool during their first six weeks of PHP treatment. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the Exp-ED chatbot app, including design issues and engagement barriers; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain. Success will be evaluated using pre-determined benchmarks derived from previous mental health chatbot research. This project has two aims:

Aim 1: Iteratively adapt an exposure therapy chatbot app for AYAs with EDs. The investigators will conduct monthly reviews of mixed-methods data and use the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to systematically document and evaluate modifications to the chatbot app. Each revised version will be tested with new participants, creating an iterative development process that continues throughout the project period. All adaptation decisions and their empirical foundations will be documented to create a comprehensive record of the app's development via implementation science frameworks.

Aim 2. Evaluate the feasibility, usability, acceptability, and preliminary efficacy of the Exp-ED chatbot app. H2.1: The investigators will recruit ≥50% of eligible AYAs with EDs. H2.2: Over the six-week project period, participants will use the app ≥18 times. H2.3: Participants will engage with the chatbot for ≥100 minutes total. H2.4: Participants will rate the Exp-ED chatbot app as acceptable (score ≥68 on the System Usability Scale). H2.5: Participants will report a ≥50% reduction in anxiety about weight gain.

Вмешательства

Поведенческое "Exp-ED" Digital Exposure-Therapy Chatbot app
Exp-ED is a text-based digital health application designed for smartphones and personal computers. It provides exposure-based content to adolescents and young adults with eating disorders. The chatbot guides users through exposure exercises (structured steps to reduce anxiety over time), records subjective distress ratings (self-reported anxiety scores), and offers evidence-based coping prompts. These sessions are intended to supplement clinical care during a six-week partial hospitalization pro

Первичные конечные точки

Number of times participants use web-app. [Срок оценки: End of Week 2, End of Week 4, End-of-Treatment (Week 6)]
Number of minutes participants engage with the web-app. [Срок оценки: End of Week 2, End of Week 4, End-of-Treatment (Week 6)]
Percent of eligible Adolescents and Young Adults Consented [Срок оценки: Through study completion, an average of 1 year]
System Usability Scale Survey (SUS) [Срок оценки: End of Week 2, End of Week 4, End-of-Treatment (Week 6)]
Weight Gain Anxiety Questionnaire [Срок оценки: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)]

Вторичные конечные точки (7)

Clinical Impairment Assessment (CIA) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Eating Disorder Fear Questionnaire (EDFQ) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Fear of Food Measure (FOFM) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, End-of-Treatment (Week 6)]
Eating Anxiety Questionnaire [Срок оценки: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)]

Критерии участия

Критерии включения

Age is between or equal to 12-26 years
Admitted to the Penn State Health Eating Disorder Partial Hospital Program (PHP) or Intensive Outpatient Program (IOP)
Have a personal smartphone
Have a diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), or other specified feeding or eating disorder (OSFED)
Be English speaking