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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH132786 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Bulimia Nervosa | Experimental | 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. |
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| Participants without Bulimia Nervosa | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting state | Other | 16 hours of fasting |
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| Measure | Description | Time Frame |
|---|---|---|
| Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task | Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors | 1-2.5 hours after a 16-hour fast (fasted state) |
| Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task | Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors | 1-2.5 hours after a standardized meal (fed state) |
| Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task | Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control | 1-2.5 hours after a 16-hour fast (fasted state) |
| Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task | Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control | 1-2.5 hours after a standardized meal (fed state) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent correct responses to stop trials and the trial-by-trial association | 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 | 1-2.5 hours after a 16-hour fast (fasted state) |
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Inclusion Criteria:
Additional Inclusion Criteria for Women with Bulimia Nervosa:
Exclusion Criteria:
The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riley Macks, B.A. | Contact | (212) 824-9545 | riley.macks@mssm.edu | |
| Riley Macks | Contact | (212) 824-9545 | riley.macks@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura A Berner, Ph.D. | Mount Sinai Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Specify Other Time FrameWithin one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
Any purpose. Specify Other Mechanism All data will be deposited to the National Data Archive (NDA) starting 12 months after the award begins and will be deposited every 6 months thereafter following the usual NDA data submission dates. The research community will be able to find the data through this study's NDA Collection C4723. The research community will have access to the data within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
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| Fed state | Other | Fed a standardized meal |
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| Magnetic Resonance Imaging | Other | Neuroimaging with computational modeling |
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| Percent correct responses to stop trials and the trial-by-trial association | 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 | 1-2.5 hours after a standardized meal (fed state) |
| Cognitive Effort Discounting Task Behavioral Performance | 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 | 1-2.5 hours after a 16-hour fast (fasted state) |
| Cognitive Effort Discounting Task Behavioral Performance | 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 | 1-2.5 hours after a standardized meal (fed state) |
| Binge-eating Severity | 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. | Baseline and 6-month follow-up |
| Compensatory Behavior Severity | 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. | Baseline and 6-month follow-up |
| Dietary Restriction Severity | 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. | Baseline and 6-month follow-up |