Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Participants with Bulimia Nervosa
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.
Intervention: Fasting state (Other)
Participants with Bulimia Nervosa
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.
Intervention: Fed state (Other)
Participants with Bulimia Nervosa
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.
Intervention: Magnetic Resonance Imaging (Other)
Participants without Bulimia Nervosa
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.
Intervention: Fasting state (Other)
Participants without Bulimia Nervosa
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.
Intervention: Fed state (Other)
Participants without Bulimia Nervosa
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.
Intervention: Magnetic Resonance Imaging (Other)
Outcomes
Primary Outcomes
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Time Frame: 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
Time Frame: 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
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Time Frame: 1-2.5 hours after a 16-hour fast (fasted state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Time Frame: 1-2.5 hours after a 16-hour fast (fasted state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Secondary Outcomes
- Binge-eating Severity(Baseline and 6-month follow-up)
- Percent correct responses to stop trials and the trial-by-trial association(1-2.5 hours after a standardized meal (fed state))
- Cognitive Effort Discounting Task Behavioral Performance(1-2.5 hours after a standardized meal (fed state))
- Compensatory Behavior Severity(Baseline and 6-month follow-up)
- Dietary Restriction Severity(Baseline and 6-month follow-up)
- Percent correct responses to stop trials and the trial-by-trial association(1-2.5 hours after a 16-hour fast (fasted state))
- Cognitive Effort Discounting Task Behavioral Performance(1-2.5 hours after a 16-hour fast (fasted state))
Investigators
Laura Berner
Assistant Professor
Icahn School of Medicine at Mount Sinai
