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NCT Number: NCT04917068

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Carol B Peterson, PhD

CONTACT

612-273-9811

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Duration of illness

    Time frame: 1-2 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carol B Peterson, PhD

CONTACT

[email protected]

(612)-273-9811

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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