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Clinical Trials/NCT03604172
NCT03604172
Completed
N/A

Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder

University of Pennsylvania1 site in 1 country40 target enrollmentAugust 8, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Binge Eating Disorder
Sponsor
University of Pennsylvania
Enrollment
40
Locations
1
Primary Endpoint
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the impact of CBT on neural responses to binge eating stimuli.

Detailed Description

Females with a BMI\>/=25 kg/m2 and BED will be randomized to either a 16-week, one-on-one CBT intervention (n=20) or a waitlist control (WL; n=20). Both groups will have blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. During the scans, participants will complete the following tasks: 1) food-specific stop signal task (SST), and 2) script-driven imagery of binge foods.

Registry
clinicaltrials.gov
Start Date
August 8, 2018
End Date
November 22, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
  • Ages 18 to 45 years of age
  • BMI \>/=25 kg/m2
  • Premenopausal
  • Able to provide informed consent
  • Right-handed
  • Eligible female patients will be:
  • Non-pregnant, evidenced by a negative urine dipstick pregnancy test
  • Non-lactating
  • Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study

Exclusion Criteria

  • Weight \> 158.8 kg (350 lbs, due to scanner weight restrictions)
  • Supine abdominal width (with arms folded above) \> 70 cm or sagittal diameter \> 50 cm (due to scanner dimension restrictions)
  • Pregnant or nursing (or plans to become pregnant in the next 5 months)
  • Evidence of psychiatric disorder that significantly interferes with daily living
  • Active suicidal ideation
  • Type 1 diabetes or type 2 diabetes or A1C \> 6.5%
  • Use of weight loss medications or other agents known to affect body weight (e.g., oral glucocorticoids, second-generation antipsychotic medications) in the past 3 months
  • Psychiatric hospitalization within the past 6 months
  • Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
  • Self-reported use of illicit drugs within the past 30 days

Outcomes

Primary Outcomes

Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task

Time Frame: Change from baseline to 16 weeks

BOLD fMRI (neural) response to high-calorie food cues during the food-specific stop-signal task in reward regions of interest. Reward-regions included BOLD response of the combination of prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum

Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery

Time Frame: Change from baseline to 16 weeks

BOLD fMRI response to descriptions of binge eating episodes during script-driven imagery (contrast in reward-regions of interest between food vs neutral stimuli). Reward-regions included combination of BOLD response in the prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum.

Secondary Outcomes

  • Binge Eating Episodes(Change from baseline to 16 weeks)
  • Reward-based Eating Drive(Change from baseline to 16 weeks)
  • Dietary Disinhibition(Change from baseline to 16 weeks)

Study Sites (1)

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