Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
6 мая 2026 г. обновлено: Laura Berner, Icahn School of Medicine at Mount Sinai
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention
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.
Обзор исследования
Статус
Еще не набирают
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
40
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sila Sozeri, B.A.
- Номер телефона: (212) 201-2679
- Электронная почта: sila.sozeri@mssm.edu
Учебное резервное копирование контактов
- Имя: Laura A. Berner, Ph.D.
- Электронная почта: laura.berner@mssm.edu
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10027
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
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Главный следователь:
- Laura A. Berner
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Real fNIRS Neurofeedback and SmartPhone Intervention Arm
Participants assigned to the experimental arm will see their true, real-time brain activation (i.e., active real-time neurofeedback) during the neurofeedback session.
This activation will be displayed to the participant as a thermometer that will increase as brain activation in the target region increases.
During the 4 week text-messaging intervention after neurofeedback, the active real-time neurofeedback group will be prompted to use neurofeedback strategies that increased their real PFC activation.
Participants will also be directed to use these strategies in response to any unexpected urges each day.
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Участникам будет предложено использовать нейробиоуправление в режиме реального времени fNIRS для неинвазивной регуляции нейронной активации, связанной с симптомами у людей с нервной булимией.
Во время обучения участники будут просматривать изображения на экране компьютера, слушать звуки и пить коктейль.
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.
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Фальшивый компаратор: Sham-Control fNIRS Neurofeedback and SmartPhone Intervention Arm
Participants assigned to the sham-control arm will see false feedback (or a fake signal) during the neurofeedback session.
During the 4 week text-messaging intervention after neurofeedback, the sham neurofeedback group will be prompted to use neurofeedback strategies they reported using when the sham feedback they saw was highest.
Participants will also be directed to use these strategies in response to any unexpected urges each day.
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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.
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Временное ограничение: Approximately 6 weeks
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The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
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Approximately 6 weeks
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Go/no-go task performance
Временное ограничение: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Participants will complete a go/no-go task four times to measure inhibitory control.
Participants' behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli.
Participants' percentages of error can range from 0% to 100%.
A higher percentage indicates lower behavioral performance on the task.
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Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Loss-of-control eating and compensatory behavior frequencies
Временное ограничение: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Frequency of loss-of-control eating and compensatory episodes in the past 28 days assessed via the EDE-Q.
Participants will self-report on how often loss-of-control eating and compensatory episodes occur before and after each phase of intervention (neurofeedback training and 4-week text messaging intervention) and at follow-up.
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Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Eating Loss of Control Severity Subscale Score
Временное ограничение: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Participants will rate the severity of their feelings of loss of control over eating in the past 28 days before and after each phase of intervention (neurofeedback training and 4-week text messaging intervention) and at follow-up on a Likert-type scale from 0-10.
Higher score indicates greater severity of loss of control.
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Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Loss-of-control eating and compensatory behavior frequencies
Временное ограничение: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Participants will report how often loss-of-control eating and compensatory episodes occur using electronic surveys throughout each phase of the intervention and at follow-up.
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Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Severity of loss-of-control eating
Временное ограничение: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Participants will rate the severity of their feelings of loss of control over eating throughout each phase of the intervention and at follow-up on a Likert-type scale from 1-5.
Higher score indicates greater severity of loss of control.
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Baseline through study completion, including 1-month follow-up (around 20 weeks)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Intensity of urges to eat and binge eat
Временное ограничение: 4 weeks
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Participants will rate the intensity of their urges to engage in eating and binge eating using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5.
Higher scores indicate greater intensity.
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4 weeks
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Intensity of food cravings
Временное ограничение: 4 weeks
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Participants will rate the intensity of their food cravings using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5.
Higher scores indicate greater intensity.
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4 weeks
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Sense of control over behavior in general
Временное ограничение: 4 weeks
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Participants will rate their sense of control over their behavior in general using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5.
Lower scores indicate greater control.
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4 weeks
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Sense of control over eating
Временное ограничение: 4 weeks
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Participants will rate their sense of control over their eating using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5.
Lower scores indicate greater control.
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4 weeks
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Changes in urges to binge eat following strategy use
Временное ограничение: 4 weeks
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Participants will rate the effect of prompted or unprompted daily life neurofeedback strategy use on urges to binge eat using daily electronic surveys throughout the smartphone intervention on a Likert-type scale from 1-5.
Higher scores indicate greater reduction in urges.
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4 weeks
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Changes in food cravings following strategy use
Временное ограничение: 4 weeks
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Participants will rate the effect of prompted or unprompted daily life neurofeedback strategy use on food cravings using daily electronic surveys throughout the smartphone intervention on a Likert-type scale from 1-5.
Higher scores indicate greater reduction in cravings.
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4 weeks
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Changes in sense of control in general following strategy use
Временное ограничение: 4 weeks
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Participants will rate changes in their sense of control in general following prompted or unprompted use of neurofeedback strategies in daily life using daily electronic surveys throughout the smartphone intervention on a 1-5 Likert-type scale.
Higher scores indicate greater control.
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4 weeks
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Changes in sense of control over eating following strategy use
Временное ограничение: 4 weeks
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Participants will rate changes in their sense of control over eating following prompted or unprompted use of neurofeedback strategies in daily life using daily electronic surveys throughout the smartphone intervention on a 1-5 Likert-type scale.
Higher scores indicate greater control.
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4 weeks
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Prevention and termination of loss-of-control eating episodes following strategy use
Временное ограничение: 4 weeks
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Participants will report on prevented or terminated loss-of-control eating episodes following prompted or unprompted use of neurofeedback strategies in daily life using daily electronic surveys throughout the smartphone intervention on a binary (yes/no) response scale.
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4 weeks
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Prevention of compensatory behaviors following strategy use
Временное ограничение: 4 weeks
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Participants will report on the prevention of compensatory behavior engagement following prompted or unprompted use of neurofeedback strategies in daily life using daily electronic surveys throughout the smartphone intervention on a binary (yes/no) response scale.
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4 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinai
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
25 апреля 2026 г.
Первичное завершение (Оцененный)
14 декабря 2028 г.
Завершение исследования (Оцененный)
14 декабря 2028 г.
Даты регистрации исследования
Первый отправленный
6 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
6 мая 2026 г.
Первый опубликованный (Действительный)
12 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY-25-00979
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Сроки обмена IPD
Immediately following publication and ending 5 years following article publication.
Критерии совместного доступа к IPD
To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, all researchers who wish to analyze and publish the data must sign an agreement ensuring that: the requesting institution's IRB or equivalent body has approved the requested use; the dataset will only be used for studying health, medical, or biomedical conditions and does not include the study of population origins or ancestry; the funding agency (One Mind) will be acknowledged appropriately for their financial support of the original data collection.
Data are available for 5 years after article publication via direct request to the investigator (laura.berner@mssm.edu).
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .