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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Binge Eating Disorder, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Behavioral: Waitlist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy<br>16-week cognitive behavioral therapy intervention for binge eating disorder | Behavioral: Cognitive behavioral therapy<br>* 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.<br>|
| Other: Waitlist control<br>16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy | Behavioral: Waitlist<br>* The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task | 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 | Change from baseline to 16 weeks | 
| Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery | 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. | Change from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating Episodes | Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes. | Change from baseline to 16 weeks | 
| Reward-based Eating Drive | Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive. | Change from baseline to 16 weeks | 
| Dietary Disinhibition | Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating. | Change from baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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binge eating disorder, obesity, cognitive behavioral therapy