Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

NCT07581158 | Not Yet Recruiting

• 1 other identifier: STUDY-25-00979
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bulimia Nervosa; Feeding and Eating Disorders; Mental Disorders

Keywords

fNIRS; fNIRS neurofeedback; smartphone intervention; eating disorders; bulimia nervosa; bulimia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Loss-of-control eating and compensatory behavior frequencies

  Baseline through study completion, including 1-month follow-up (around 20 weeks)

• Severity of loss-of-control eating

  Baseline through study completion, including 1-month follow-up (around 20 weeks)

Other Outcomes (10)

• Intensity of urges to eat and binge eat

  4 weeks

• Intensity of food cravings

  4 weeks

• Sense of control over behavior in general

  4 weeks

Study Arms (2)

Real fNIRS Neurofeedback and SmartPhone Intervention Arm

EXPERIMENTAL

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; Other: SmartPhone Intervention

Sham-Control fNIRS Neurofeedback and SmartPhone Intervention Arm

SHAM COMPARATOR

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: Sham-Control fNIRS Neurofeedback; Other: SmartPhone Intervention

Interventions

SmartPhone Intervention OTHER

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.

Real fNIRS Neurofeedback and SmartPhone Intervention Arm; Sham-Control fNIRS Neurofeedback and SmartPhone Intervention Arm

Real fNIRS Neurofeedback OTHER

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.

Real fNIRS Neurofeedback and SmartPhone Intervention Arm

Sham-Control fNIRS Neurofeedback OTHER

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.

Sham-Control fNIRS Neurofeedback and SmartPhone Intervention Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggests that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of males and females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Feeding and Eating Disorders; Mental Disorders; Bulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia

Study Officials

• Laura A. Berner, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sila Sozeri, B.A.

CONTACT

(212) 201-2679; sila.sozeri@mssm.edu

Laura A. Berner, Ph.D.

CONTACT

laura.berner@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Participants will be assigned to one of two conditions, either the experimental or sham-control arm.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 14, 2028
• Study Completion (Estimated): December 14, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication and ending 5 years following article publication.
• 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).

Locations

US (1)