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Набор скоро начнётся NCT07632248

A Study Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

Без фазы С лечением Eating Disorders Body Image

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: FlexED, Educational Control.
Кому может быть актуально
Состояния в реестре: Eating Disorders, Body Image. Базовые параметры: 15 лет — 25 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

A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Обзор

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online. The main questions are: Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose? Participants will: Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images. Participants are followed for about 1 year.

Вмешательства

  • Поведенческое FlexED
    Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.
  • Поведенческое Educational Control
    Intervention consists of seven digital online sessions of education about eating disorders and body image. Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.

Первичные конечные точки

  • Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ) [Срок оценки: Baseline, 4, 8, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Body-Image Stroop Bias Score [Срок оценки: Baseline, 8 weeks, 24 weeks]
  • Change from Baseline in Eye Gaze Fixations - Body-Image Related Images [Срок оценки: Baseline, 8 weeks, 24 weeks]
  • Acceptability of the intervention [Срок оценки: 8 weeks]
  • Change from Baseline in Eating Disorder Examination (EDE) [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q) [Срок оценки: Baseline, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Clinical Impairment Assessment (CIA) [Срок оценки: Baseline, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) [Срок оценки: Baseline, 4, 8, 12, 24, 36, 48 weeks]
  • Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility [Срок оценки: Baseline, 8 Weeks]
Вторичные конечные точки (3)
  • Change from Baseline in Heart Rate when Viewing Emotional Film Clips [Срок оценки: Baseline, 8 weeks, 24 weeks]
  • Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST) [Срок оценки: Baseline, 24 weeks]
  • Change from Baseline in Response Inhibition as assessed by Go/No-Go Task [Срок оценки: Baseline, 8 weeks, 24 weeks]

Критерии участия

Критерии включения

  • Female between the age of 15-25 years old.
  • Weight Concerns Scale score of >=47.
  • Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).

Критерии исключения

  • Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.
  • Change in psychotropic medications in the past month.
  • Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.
  • Bipolar disorder not being treated with medication.
  • Currently in treatment for an eating disorder.
  • Non-English speaking.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Duke University — Durham

Идентификаторы

NCT: NCT07632248 · Pro00111571_1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗