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Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

6 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10027
        • Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
        • Hoofdonderzoeker:
          • Laura A. Berner

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Echte fNIRS Neurofeedback
Deelnemers zullen worden geïnstrueerd om real-time fNIRS-neurofeedback te gebruiken om op niet-invasieve wijze neurale activering te reguleren die gepaard gaat met symptomen bij personen met boulimia nervosa. Tijdens de training bekijken deelnemers beelden op een computerscherm, luisteren naar geluiden en consumeren een shake.
Ander: 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.
Sham-vergelijker: 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.
Ander: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Loss-of-control eating and compensatory behavior frequencies
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intensity of urges to eat and binge eat
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Icahn School of Medicine at Mount Sinai

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

25 april 2026

Primaire voltooiing (Geschat)

14 december 2028

Studie voltooiing (Geschat)

14 december 2028

Studieregistratiedata

Eerst ingediend

6 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY-25-00979

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

Immediately following publication and ending 5 years following article publication.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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