Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
2026年5月6日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sila Sozeri, B.A.
- 電話番号：(212) 201-2679
- メール：sila.sozeri@mssm.edu
研究連絡先のバックアップ
- 名前：Laura A. Berner, Ph.D.
- メール：laura.berner@mssm.edu
研究場所
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New York
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New York、New York、アメリカ、10027
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
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主任研究者：
- Laura A. Berner
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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参加者は、リアルタイム fNIRS ニューロフィードバックを使用して、神経性過食症患者の症状に関連する神経活性化を非侵襲的に調節するように指示されます。
トレーニング中、参加者はコンピューター画面で画像を表示し、音を聞き、シェイクを消費します。
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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Loss-of-control eating and compensatory behavior frequencies
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intensity of urges to eat and binge eat
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Laura A. Berner, Ph.D.、Icahn School of Medicine at Mount Sinai
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年4月25日
一次修了 (推定)
2028年12月14日
研究の完了 (推定)
2028年12月14日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY-25-00979
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD 共有時間枠
Immediately following publication and ending 5 years following article publication.
IPD 共有アクセス基準
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).
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。