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Идёт набор NCT05763849

Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Без фазы С лечением Anorexia Nervosa

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: Interoceptive Exposure Treatment (IE), Family-Based Treatment (FBT).
Кому может быть актуально
Состояния в реестре: Anorexia Nervosa. Базовые параметры: 12 лет — 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
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Официальное название

A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Обзор

This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.

Подробное описание

A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

Вмешательства

  • Поведенческое Interoceptive Exposure Treatment (IE)
    Interoceptive Exposure Therapy (IE) targets food avoidance in Anorexia Nervosa. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Early sessions include using exposure to foods and counterconditioning to pair a positive stimulus with a food that would typically produce food avoidance. Parents are trained to model this at home. Sessions mid-way thr
  • Поведенческое Family-Based Treatment (FBT)
    Family-Based Therapy (FBT) includes parent-enforced contingencies to increase value of eating and decrease the value of food avoidance. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Sessions consist of checking in with the patient, discussion of the week's implementation of refeeding, and helping parents separate the illness from their child.

Первичные конечные точки

  • Change in Expected Body Weight Percentage [Срок оценки: Baseline and 6-months]
  • Change in Expected Body Weight Percentage [Срок оценки: Baseline and 18-months]
  • Change in Impairment [Срок оценки: Baseline and 6-months]
  • Change in Impairment [Срок оценки: Baseline and 18-months]
Вторичные конечные точки (8)
  • Change in Autonomous Eating [Срок оценки: Baseline and 6-months]
  • Change in Autonomous Eating [Срок оценки: Baseline and 18-months]
  • Change in Food Cue Learning [Срок оценки: Baseline and 6-months]
  • Change in Food Cue Learning [Срок оценки: Baseline and 18-months]
  • Change in Eating Disorder Symptoms [Срок оценки: Baseline and 6-months]
  • Change in Eating Disorder Symptoms [Срок оценки: Baseline and 18-months]
  • Change in Nonjudgmental Body Awareness [Срок оценки: Baseline and 6-months]
  • Change in Nonjudgmental Body Awareness [Срок оценки: Baseline and 18-months]

Критерии участия

Критерии включения

  • Aged 12-18
  • Speak English
  • Permission from pediatrician or equivalent to receive outpatient care
  • Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
  • Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories

Критерии исключения

  • Comorbid psychotic or bipolar disorder
  • Active suicidal ideation
  • Current substance dependence
  • Psychiatric medication initiated or dosage changes <2 weeks from baseline
  • Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Department of Psychiatry, Eating and Weight Disorders Program — New York

Идентификаторы

NCT: NCT05763849 · STUDY-22-01323 · 1R01MH131655

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗