Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

6. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10027
        • Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
        • Hauptermittler:
          • Laura A. Berner

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Echtes fNIRS-Neurofeedback
Die Teilnehmer werden angewiesen, Echtzeit-fNIRS-Neurofeedback zu verwenden, um die neuronale Aktivierung im Zusammenhang mit Symptomen bei Personen mit Bulimia nervosa nicht-invasiv zu regulieren. Während des Trainings sehen sich die Teilnehmer Bilder auf einem Computerbildschirm an, hören Geräusche und konsumieren einen Shake.
Sonstiges: 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.
Schein-Komparator: 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.
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Zeitfenster: Approximately 6 weeks
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Approximately 6 weeks
Go/no-go task performance
Zeitfenster: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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.
Baseline through study completion, including 1-month follow-up (around 20 weeks)
Loss-of-control eating and compensatory behavior frequencies
Zeitfenster: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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.
Baseline through study completion, including 1-month follow-up (around 20 weeks)
Eating Loss of Control Severity Subscale Score
Zeitfenster: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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.
Baseline through study completion, including 1-month follow-up (around 20 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Loss-of-control eating and compensatory behavior frequencies
Zeitfenster: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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.
Baseline through study completion, including 1-month follow-up (around 20 weeks)
Severity of loss-of-control eating
Zeitfenster: Baseline through study completion, including 1-month follow-up (around 20 weeks)
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.
Baseline through study completion, including 1-month follow-up (around 20 weeks)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intensity of urges to eat and binge eat
Zeitfenster: 4 weeks
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.
4 weeks
Intensity of food cravings
Zeitfenster: 4 weeks
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.
4 weeks
Sense of control over behavior in general
Zeitfenster: 4 weeks
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.
4 weeks
Sense of control over eating
Zeitfenster: 4 weeks
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.
4 weeks
Changes in urges to binge eat following strategy use
Zeitfenster: 4 weeks
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.
4 weeks
Changes in food cravings following strategy use
Zeitfenster: 4 weeks
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.
4 weeks
Changes in sense of control in general following strategy use
Zeitfenster: 4 weeks
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.
4 weeks
Changes in sense of control over eating following strategy use
Zeitfenster: 4 weeks
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.
4 weeks
Prevention and termination of loss-of-control eating episodes following strategy use
Zeitfenster: 4 weeks
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.
4 weeks
Prevention of compensatory behaviors following strategy use
Zeitfenster: 4 weeks
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.
4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Icahn School of Medicine at Mount Sinai

Ermittler

  • Hauptermittler: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinai

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

25. April 2026

Primärer Abschluss (Geschätzt)

14. Dezember 2028

Studienabschluss (Geschätzt)

14. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

12. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY-25-00979

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD-Sharing-Zeitrahmen

Immediately following publication and ending 5 years following article publication.

IPD-Sharing-Zugriffskriterien

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).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren