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Набор скоро начнётся NCT07641205

Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II

Без фазы С лечением Avoidant/Restrictive Food Intake Disorder (ARFID)

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: Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR), Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder.
Кому может быть актуально
Состояния в реестре: Avoidant/Restrictive Food Intake Disorder (ARFID). Базовые параметры: 10 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

Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects

Обзор

This study is a randomized controlled trial assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).

Вмешательства

  • Поведенческое Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
    CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.
  • Поведенческое Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
    Nutrition counseling will be provided by skilled registered dietitians at the MGH Translational and Clinical Research Center (TCRC). Sessions focus on the foods necessary for a healthy diet, how to meet nutritional needs, how to incorporate healthy exercise, and support for making these changes. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.

Первичные конечные точки

  • Pica, ARFID, and Rumination Disorder Interview [Срок оценки: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.]
  • Pica, ARFID, and Rumination Disorder ARFID Questionnaire [Срок оценки: Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.]
Вторичные конечные точки (2)
  • General Nutrition Knowledge Questionnaire [Срок оценки: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)]
  • 4-Day Food Record [Срок оценки: Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)]

Критерии участия

Критерии включения

  • Males and Females ages 10-18 years old
  • Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
  • Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
  • Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
  • Fluency and literacy in English

Критерии исключения

  • Patient requires weight restoration treatment (e.g., < 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
  • Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
  • Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
  • Substance/alcohol use disorder (active within the past month) via MINI KID
  • Medical instability requiring inpatient care according to the American Psychiatric Association 2006 treatment guidelines for eating disorders
  • Laboratory abnormalities indicating a need for higher level of care (assessed by complete blood count and comprehensive metabolic panel) exclusionary for randomization
  • Complete lack of oral intake (suggesting a need for inpatient care)
  • Tube feeding (suggesting a need for tube weaning) Significant weight/shape concern-motivating eating pathology as evidenced by a global Eating Disorders Examination Questionnaire (EDE-Q) score greater than 4
  • Active suicidal ideation with intent or plan via the 5-item Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
  • Contraindications to MRI
  • History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
  • Medical history of intellectual disability
  • Illiteracy

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Eating Disorders Clinical and Research Program — Boston

Идентификаторы

NCT: NCT07641205 · P202600305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗