Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-05-13
2027-12-31
Brief Summary
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Detailed Description
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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). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Real fNIRS Neurofeedback 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.
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.
Sham-Control fNIRS Neurofeedback Arm
Participants assigned to the sham-control arm will see false feedback (or a fake signal) that is not connected to their right vlPFC activation during the neurofeedback session.
Sham-Control fNIRS Neurofeedback
Participants will be instructed to use sham 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.
Interventions
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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.
Sham-Control fNIRS Neurofeedback
Participants will be instructed to use sham 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.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 45 years
* Meet diagnostic criteria for bulimia nervosa
* Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
* English-speaking
Exclusion Criteria
* Current psychotherapy focused primarily on eating disorder symptoms
* Pregnancy or planned pregnancy, or lactation during the study period
* Allergy to ingredients in the standardized meal or in the shake
18 Years
45 Years
FEMALE
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Laura Berner
Assistant Professor
Principal Investigators
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Laura A Berner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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GCO 21-2078
Identifier Type: -
Identifier Source: org_study_id
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