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Набор скоро начнётся NCT07581158

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

Без фазы С лечением Bulimia Nervosa Feeding and Eating Disorders Mental Disorders

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: Real fNIRS Neurofeedback, Sham-Control fNIRS Neurofeedback, SmartPhone Intervention.
Кому может быть актуально
Состояния в реестре: Bulimia Nervosa, Feeding and Eating Disorders, Mental Disorders. Базовые параметры: 18 лет — 55 лет · Женщины.
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

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention

Обзор

The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using wearable brain imaging, functional near-infrared spectroscopy (fNIRS), together with a brain-based 4-week text-messaging intervention. The investigators will examine how these interventions may influence inhibitory control and eating disorder symptoms in women with bulimia nervosa.

Подробное описание

The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS and a 4-week text messaging intervention. Specifically, the study aims 1) to use neurofeedback during eating to evaluate the causal role of PFC function in BN; and 2) to test individualized, neuro-based text messaging for treatment of BN. Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating and text-messaging intervention). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person assessment, six in-person neurofeedback training sessions, 4 weeks of text-message intervention, behavioral tasks, online questionnaires, and online symptom assessments (before the neurofeedback visits and following the 4-week text message intervention), and a follow-up remote assessment.

Вмешательства

  • Другое Real fNIRS Neurofeedback
    Participants will be instructed to use real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
  • Другое Sham-Control fNIRS Neurofeedback
    Participants will be instructed to use sham-control fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
  • Другое SmartPhone Intervention
    Over the subsequent 4 weeks, at the specific times when each individual is most likely to engage in eating disorder symptoms, participants will receive personalized messages to use mental strategies from their real-time or their sham-control fNIRS neurofeedback.

Первичные конечные точки

  • Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity [Срок оценки: Approximately 6 weeks]
  • Go/no-go task performance [Срок оценки: Baseline through study completion, including 1-month follow-up (around 20 weeks)]
  • Loss-of-control eating and compensatory behavior frequencies [Срок оценки: Baseline through study completion, including 1-month follow-up (around 20 weeks)]
  • Eating Loss of Control Severity Subscale Score [Срок оценки: Baseline through study completion, including 1-month follow-up (around 20 weeks)]
Вторичные конечные точки (2)
  • Loss-of-control eating and compensatory behavior frequencies [Срок оценки: Baseline through study completion, including 1-month follow-up (around 20 weeks)]
  • Severity of loss-of-control eating [Срок оценки: Baseline through study completion, including 1-month follow-up (around 20 weeks)]

Критерии участия

Критерии включения

  • Female
  • Aged 18 to 55 years
  • Meet diagnostic criteria for bulimia nervosa (BN) or BN of low frequency and/or limited duration
  • Current body mass index greater than or equal to 18.5kg/m2 but under 40kg/m2
  • English-speaking

Критерии исключения

  • Ongoing medical treatment or planned/recent change in medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
  • Current psychotherapy focused primarily on eating disorder symptoms
  • Pregnancy or planned pregnancy, or lactation during the study period
  • Allergy to ingredients in the shake

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
Другое

Центры проведения

США · 1 центр
  • Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07581158 · STUDY-25-00979

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗