University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03604172
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The cognitive behavioral therapy intervention will consist of weekly, 50-minute individual meetings for 16 weeks with a clinician trained in cognitive behavioral therapy for binge eating disorder.
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
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
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.
Time frame: Change from baseline to 16 weeks
Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Time frame: Change from baseline to 16 weeks
Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.
Time frame: Change from baseline to 16 weeks
Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
University of Pennsylvania
Other
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