Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
6. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sila Sozeri, B.A.
- Telefonnummer: (212) 201-2679
- E-post: sila.sozeri@mssm.edu
Studer Kontakt Backup
- Navn: Laura A. Berner, Ph.D.
- E-post: laura.berner@mssm.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10027
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
-
Hovedetterforsker:
- Laura A. Berner
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Deltakerne vil bli instruert om å bruke sanntids fNIRS nevrofeedback for å ikke-invasivt regulere nevrale aktivering assosiert med symptomer hos individer med bulimia nervosa.
Under treningen vil deltakerne se bilder på en dataskjerm, lytte til lyder og innta en shake.
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-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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Loss-of-control eating and compensatory behavior frequencies
Tidsramme: 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
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensity of urges to eat and binge eat
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. april 2026
Primær fullføring (Antatt)
14. desember 2028
Studiet fullført (Antatt)
14. desember 2028
Datoer for studieregistrering
Først innsendt
6. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY-25-00979
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD-delingstidsramme
Immediately following publication and ending 5 years following article publication.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .