Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
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
- •Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- •Loss of ≥ 10 lb of body weight within the past 3 months
- •History of (or plans for) bariatric surgery
- •Visual, auditory, or other impairment that would affect task performance
- •Epilepsy or other brain injury
- •Participation in individual psychotherapy for BED in the prior 3 months
- •Inability to attend treatment and lack of capacity to provide informed consent
- •Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
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)