Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
6 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sila Sozeri, B.A.
- Número de teléfono: (212) 201-2679
- Correo electrónico: sila.sozeri@mssm.edu
Copia de seguridad de contactos de estudio
- Nombre: Laura A. Berner, Ph.D.
- Correo electrónico: laura.berner@mssm.edu
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10027
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
-
Investigador principal:
- Laura A. Berner
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
Se indicará a los participantes que usen neurorretroalimentación fNIRS en tiempo real para regular de manera no invasiva la activación neuronal asociada con los síntomas en personas con bulimia nerviosa.
Durante la capacitación, los participantes verán imágenes en la pantalla de una computadora, escucharán sonidos y consumirán un batido.
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.
|
|
Comparador falso: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Loss-of-control eating and compensatory behavior frequencies
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intensity of urges to eat and binge eat
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
25 de abril de 2026
Finalización primaria (Estimado)
14 de diciembre de 2028
Finalización del estudio (Estimado)
14 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY-25-00979
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Marco de tiempo para compartir IPD
Immediately following publication and ending 5 years following article publication.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .