Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT04917068
Collaborator
(none)
100
1
20
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Bulimia nervosa (BN), an eating disorder characterized by recurrent bulimic episodes of binge eating and often persists in spite of treatment, likely indicating ineffectively targeted maintenance mechanisms. Treatment outcome data suggest that < 30-45% of adults who receive treatment for BN exhibit prolonged remission. Further, BN is often characterized by a worsening course in which symptom severity increases with duration of illness. Intervention advances require identification of both the mechanisms that underlie reward derived from bulimic behavior and the mechanisms that maintain these behaviors over time. Current treatments for BN focus on immediate antecedents and consequences of bulimic behavior, despite the possibility that the reward derived from these behaviors may occur well before this point during the anticipation of binge eating and purging. A majority (>75%) of individuals with BN report "planning" some or most of their bulimic episodes. Thus, determining the role of reward anticipation in BN will facilitate the application of novel interventions that more precisely target these neglected mechanisms. Further, research indicates that reward mechanisms become increasingly focused on anticipation in later phases of reward learning. Therefore, it is important to determine how reward anticipation processes contribute to the maintenance of bulimic behaviors and interact with illness duration to facilitate BN chronicity. 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
    Actual Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. The Positive and Negative Affect Schedule (PANAS) self-reported negative affect [1-2 months]

      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.

    2. The Positive and Negative Affect Schedule (PANAS) self-reported positive affect [1-2 months]

      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.

    3. Activation in regions of the limbic threat network [approximately 4 hours]

      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.

    4. Activation in regions of the striatal approach network [approximately 4 hours]

      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.

    5. Frontolimbic connectivity [approximately 4 hours]

      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.

    6. Frontostriatal connectivity [approximately 4 hours]

      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.

    Secondary Outcome Measures

    1. Duration of illness [1-2 months]

      Outcome is reported as the number of days participants in the bulimia nervosa group experience illness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    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

    Exclusion Criteria:
    • 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

    • fMRI exclusions as specifiedd by the Center for Magnetic Resonance Research

    • Food allergy that cannot be accommodated through substitutions to the laboratory test snack

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Carol B Peterson, PhD, University of Minnesota Department of Psychiatry and Behavioral Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT04917068
    Other Study ID Numbers:
    • PSYCH-2020-28854
    First Posted:
    Jun 8, 2021
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2022