Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
6 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Sila Sozeri, B.A.
- Numero di telefono: (212) 201-2679
- Email: sila.sozeri@mssm.edu
Backup dei contatti dello studio
- Nome: Laura A. Berner, Ph.D.
- Email: laura.berner@mssm.edu
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10027
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
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Investigatore principale:
- Laura A. Berner
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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I partecipanti saranno istruiti a utilizzare il neurofeedback fNIRS in tempo reale per regolare in modo non invasivo l'attivazione neurale associata ai sintomi negli individui con bulimia nervosa.
Durante la formazione, i partecipanti visualizzeranno le immagini sullo schermo di un computer, ascolteranno i suoni e consumeranno un frullato.
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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Loss-of-control eating and compensatory behavior frequencies
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intensity of urges to eat and binge eat
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinai
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
25 aprile 2026
Completamento primario (Stimato)
14 dicembre 2028
Completamento dello studio (Stimato)
14 dicembre 2028
Date di iscrizione allo studio
Primo inviato
6 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
6 maggio 2026
Primo Inserito (Effettivo)
12 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY-25-00979
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Periodo di condivisione IPD
Immediately following publication and ending 5 years following article publication.
Criteri di accesso alla condivisione 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).
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .