Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Disorders; Feeding and Eating Disorders; Bulimia Nervosa
• Intervention / Treatment: Other: Real fNIRS Neurofeedback; Other: SmartPhone Intervention; Other: Sham-Control fNIRS Neurofeedback

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sila Sozeri, B.A.; Phone Number: (212) 201-2679; Email: sila.sozeri@mssm.edu
• Study Contact Backup: Name: Laura A. Berner, Ph.D.; Email: laura.berner@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Laura A. Berner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Real fNIRS Neurofeedback; Participants will be instructed to use real-time 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.; Other: 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 Comparator: 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.	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity	The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.	Approximately 6 weeks
Go/no-go task performance	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	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss-of-control eating and compensatory behavior frequencies	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of urges to eat and binge eat	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Laura A. Berner, Ph.D., Icahn School of Medicine at Mount Sinaï

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): December 14, 2028
• Study Completion (Estimated): December 14, 2028

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: fNIRS; eating disorders; bulimia nervosa; bulimia; fNIRS neurofeedback; smartphone intervention
• Additional Relevant MeSH Terms: Hyperphagia; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bulimia; Mental Disorders; Feeding and Eating Disorders; Bulimia Nervosa
• Other Study ID Numbers: STUDY-25-00979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication and ending 5 years following article publication.
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No