Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN). The research will investigate neural and psychological anticipatory processes in BN, both in the scanner and the natural environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
January 8, 2026
January 1, 2026
4.7 years
June 1, 2021
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
The Positive and Negative Affect Schedule (PANAS) self-reported negative affect
The Positive and Negative Affect Schedule (PANAS) is a self-report measure comprising two scales, one of which we will use to assess participants' negative affect. The scale includes ten Likert-style items, which participants rate from 1 = not at all to 5 = very much. Composite scores range from 10-50, and a score of 50 indicates greater negative affect. The PANAS will be administered to measure emotion at multiple times during the second visit as well as during EMA administration and to establish a baseline at the first visit.
1-2 months
The Positive and Negative Affect Schedule (PANAS) self-reported positive affect
The Positive and Negative Affect Schedule (PANAS) is a self-report measure comprising two scales, one of which we will use to assess participants' positive affect. The scale includes ten Likert-style items, which participants rate from 1 = not at all to 5 = very much. Composite scores range from 10-50, and a score of 50 indicates greater positive affect. The PANAS will be administered to measure emotion at multiple times during the second visit as well as during EMA administration and to establish a baseline at the first visit.
1-2 months
Activation in regions of the limbic threat network
fMRI will be used to assess the neural correlates of bulimic behavior anticipation. Outcome is reported as the mean z-scores from voxels in limbic regions (amygdala, hippocampus, insula) extracted from a 2x2 analysis of the BED versus HC groups in the food choice versus shopping contrast results of the fMRI task regression analysis.
approximately 4 hours
Activation in regions of the striatal approach network
fMRI will be used to assess the neural correlates of bulimic behavior anticipation. Outcome is reported as the mean z-scores from voxels in striatal regions (nucleus accumbens, caudate and putamen) extracted from a 2x2 analysis of the BED versus HC groups the food choice versus shopping contrast results of the fMRI task regression analysis.
approximately 4 hours
Frontolimbic connectivity
fMRI will be used to assess the neural correlates of bulimic behavior anticipation. Outcome is reported as the cross-correlation between the BOLD signal time series from fronto-limbic regions of interest (amygdala, hippocampus, insula, anterior cingulate cortex, medial prefrontal cortex) contrasted between food choice versus shopping tasks.
approximately 4 hours
Frontostriatal connectivity
fMRI will be used to assess the neural correlates of bulimic behavior anticipation. Outcome is reported as the cross-correlation between the BOLD signal time series from fronto-striatal regions of interest (caudate, putamen, insula, nucleus accumbens, orbitofrontal cortex) contrasted between food choice versus shopping tasks.
approximately 4 hours
Secondary Outcomes (1)
Duration of illness
1-2 months
Study Arms (2)
Bulimia Nervosa
Participants with diagnosed bulimia nervosa (BN) who will complete all tasks during Visits 1 and 2 in addition to ecological momentary assessment (EMA) procedures following Visit 2.
Healthy Control
Participants without diagnosed BN or other current or past eating disorders who will complete all tasks during Visits 1 and 2 and will not complete EMA procedures following Visit 2.
Eligibility Criteria
Adults with or without bulimia nervosa
You may qualify if:
- Bulimia nervosa (BN) and healthy control (HC) groups:
- Right-handed
- Ability to read and speak in English
- BN group only:
- Eating Disorder Examination (EDE) diagnosis of BN (i.e., at least one objective bulimic episode and one self-induced vomiting episode per week for at three months) with binge episodes always accompanied by self-induced vomiting
- Stable dose for at least 6 weeks of any recent changes in medication impacting mood, appetite, or weight
- HC group only:
- No binge eating or purging episodes for the past three months on the EDE
- No current or past history of an eating disorder as diagnosed by Structured Clinical Interview for DSM-5 Disorders
You may not qualify if:
- History of gastric bypass surgery
- Medical condition acutely affecting eating behavior and/or weight (i.e., pregnancy, lactation, thyroid disease)
- Current medical or psychiatric instability (i.e., hospitalization required in the past three months)
- Lifetime history of psychosis or bipolar disorder
- History of neurological disorder or injury (i.e., stoke, head injury with \>10 minutes loss of consciousness)
- Current substance use disorder
- BMI less than 19 kg/m\^2
- Acute suicidality requiring hospitalization
- Food allergy that cannot be accommodated through substitutions to the laboratory test snack
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol B Peterson, PhD
University of Minnesota Department of Psychiatry and Behavioral Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 8, 2021
Study Start
April 1, 2022
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share