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Идёт набор NCT07600671

Eating Disorder Dynamic Intervention

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: Eating Disorder Dynamic Intervention.
Кому может быть актуально
Состояния в реестре: Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder. Базовые параметры: 18 лет — 70 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
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Официальное название

Rapid Innovation of Precision Psychiatry Interventions Using Dynamic Systems Modeling and Ecological Quasi-Experiments

Обзор

The goal of this study is to develop and test a digital program to help people with eating disorders in their everyday lives. The program uses brief surveys and sensor data collected by smartphones to understand when someone may be at higher risk for behaviors like restricting food, binge eating, or using unhealthy weight control behaviors.

Подробное описание

In this study, 170 adults with eating disorders will take part. They will regularly report on their thoughts, feelings, and behaviors throughout the day. Based on this information, the program will send "just-in-time" support, which involves short, tailored suggestions that encourage the use of helpful coping skills right when they are most needed.

The study has three main goals:

1. To better understand risk patterns:

The investigators will use real-time data to build personalized models that predict when someone is at higher risk for eating disorder behaviors based on their own data and patterns. 2. To test which therapy skills work best and why:

The investigators will examine how different evidence-based therapy skills (such as managing urges, improving mood, reducing strict dieting, and improving body image) help reduce eating disorder behaviors in daily life, and what psychological factors explain these effects. 3. To evaluate the program's usability:

The investigators will assess whether participants find the digital support helpful, easy to use, and acceptable in their daily routines.

Вмешательства

  • Поведенческое Eating Disorder Dynamic Intervention
    Participants will use a smartphone-based program designed to support eating disorder recovery in daily life. Participants will complete brief surveys about their mood, thoughts, and behaviors, and the smartphone will also passively collect activity-related data. This information is used to detect times when a person may be at higher risk for eating disorder behaviors. Participants will watch 4 video modules that introduce the core enhanced cognitive-behavioral therapy skills for eating disorders

Первичные конечные точки

  • Area under the receiver operating curve (AUC) [Срок оценки: Weeks 5 and 6 of data collection]
  • Brier Score [Срок оценки: Weeks 5 and 6 of data collection]
  • Binge eating [Срок оценки: Weeks 7 through 16 of data collection]
  • Dietary restriction [Срок оценки: Weeks 7 through 16 of data collection]
  • Compensatory behaviors [Срок оценки: Weeks 7 through 16 of data collection]
  • Feasibility and Acceptability Questionnaire [Срок оценки: End of study assessment (after week 16 of data collection)]
  • System Usability Scale [Срок оценки: End of study assessment (after week 16 of data collection)]
  • Percentage of Eligible Participants Enrolled [Срок оценки: Through study completion, an average of 4 months]
  • Attrition Rate [Срок оценки: Through study completion, an average of 4 months]
  • Percentage of JITAIs Producing Skill Use [Срок оценки: Through study completion, an average of 4 months]
Вторичные конечные точки (3)
  • Body image concerns (Eating Disorder Examination Questionnaire-Short Form) [Срок оценки: Weeks 7 through 16 of data collection]
  • Cognitive dietary restraint (Eating Disorder Examination-Questionnaire) [Срок оценки: Weeks 7 through 16 of data collection]
  • Negative affect (Positive and Negative Affect Schedule) [Срок оценки: Weeks 7 through 16 of data collection]

Критерии участия

Критерии включения

  • Age 18-70
  • At least 12 ED behaviors from the same behavioral category in the past 12 weeks (i.e., at least 12 binge eating episodes, at least 12 compensatory behaviors, and/or at least 12 instances of dietary restriction)
  • Ownership of a smartphone
  • Willingness to complete ecological momentary assessment (EMA) and sensor data collection
  • Live in the United States
  • Has a primary care provider or is willing to establish a primary care provider

Критерии исключения

  • Inability to fluently speak, read, and write in English
  • Body mass index < 17.5 kg/m2
  • Medical complications of ED symptoms requiring immediate treatment
  • Current ED-focused therapy
  • Severe psychopathology (i.e., active suicidal ideation, psychosis, bipolar disorder, or substance use disorder) or intellectual disability inhibiting engagement in study protocols

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Dartmouth College — Lebanon

Идентификаторы

NCT: NCT07600671 · STUDY00033481 · 1DP5OD039510-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗