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NCT Number: NCT07581158

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

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.

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Key information

Conditions

Bulimia Nervosa Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10027, United States

Location contact

Laura A. Berner

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity

    Time frame: Approximately 6 weeks

    The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.

  2. Go/no-go task performance

    Time frame: 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.

  3. Loss-of-control eating and compensatory behavior frequencies

    Time frame: 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.

  4. Eating Loss of Control Severity Subscale Score

    Time frame: 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.

Secondary outcomes

  1. Loss-of-control eating and compensatory behavior frequencies

    Time frame: 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.

  2. Severity of loss-of-control eating

    Time frame: 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.

Other outcomes

  1. Intensity of urges to eat and binge eat

    Time frame: 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.

  2. Intensity of food cravings

    Time frame: 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.

  3. Sense of control over behavior in general

    Time frame: 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. Sense of control over eating

    Time frame: 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.

  5. Changes in urges to binge eat following strategy use

    Time frame: 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.

  6. Changes in food cravings following strategy use

    Time frame: 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.

  7. Changes in sense of control in general following strategy use

    Time frame: 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.

  8. Changes in sense of control over eating following strategy use

    Time frame: 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.

  9. Prevention and termination of loss-of-control eating episodes following strategy use

    Time frame: 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.

  10. Prevention of compensatory behaviors following strategy use

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura A. Berner, Ph.D.

CONTACT

[email protected]

Sila Sozeri, B.A.

CONTACT

[email protected]

(212) 201-2679

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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