Changes in Inhibition and Valuation After Eating
- Conditions
- Bulimia Nervosa
- Interventions
- Other: Fasting stateOther: Fed stateOther: Magnetic Resonance Imaging
- Registration Number
- NCT05995496
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.
- Detailed Description
The overarching goal of this project is to test a neurocomputational model of BN that incorporates learning and decision-making components of control. The study combines functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in BN. More specifically, the study has the following main objectives: 1) To determine the influence of eating on control-related prediction updating in BN.; 2) To determine the influence of eating on control-related cognitive effort valuation in BN; 3) To use state-specific neural activation to predict BN symptoms.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- Female
- Aged 18 to 45 years
- Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
- Right-handed
- English-speaking
Additional Inclusion Criteria for Women with Bulimia Nervosa:
- Meet DSM-5 criteria for bulimia nervosa
- Medical instability
- Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
- Shift work
- Pregnancy, planned pregnancy, or lactation during the study period
- Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
- Any contraindication for fMRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Participants with Bulimia Nervosa Fasting state Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Participants with Bulimia Nervosa Fed state Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Participants without Bulimia Nervosa Fed state Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Participants with Bulimia Nervosa Magnetic Resonance Imaging Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Participants without Bulimia Nervosa Fasting state Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Participants without Bulimia Nervosa Magnetic Resonance Imaging Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
- Primary Outcome Measures
Name Time Method Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task 1-2.5 hours after a standardized meal (fed state) Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task 1-2.5 hours after a standardized meal (fed state) Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
- Secondary Outcome Measures
Name Time Method Binge-eating Severity Baseline and 6-month follow-up The frequency of binge-eating episodes as assessed by the Eating Disorder Examination (EDE) and Ecological Momentary Assessment (EMA). Binge-eating frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
Percent correct responses to stop trials and the trial-by-trial association 1-2.5 hours after a standardized meal (fed state) Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
Cognitive Effort Discounting Task Behavioral Performance 1-2.5 hours after a standardized meal (fed state) The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
Compensatory Behavior Severity Baseline and 6-month follow-up The frequency of compensatory behaviors as assessed by the EDE and EMA. This frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
Dietary Restriction Severity Baseline and 6-month follow-up The frequency of fasting episodes as assessed by the EDE avoidance of eating item (minimum limit = 0, maximum limit = 6); the severity of dietary restriction as assessed by the Eating Pathology Symptoms Inventory (EPSI) - restricting subscale (minimum limit=0; maximum limit=24), and the frequency of restrictive eating behaviors as assessed by EMA (minimum limit=0; no maximum limit). On all measures, a higher score indicates a greater severity.
Trial Locations
- Locations (1)
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States