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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Binge Eating Disorder
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy; Behavioral: Waitlist

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
2. Ages 18 to 45 years of age
3. BMI >/=25 kg/m2
4. Premenopausal
5. Able to provide informed consent
6. Right-handed

7. 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
8. 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:

1. Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
2. Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
3. Pregnant or nursing (or plans to become pregnant in the next 5 months)
4. Evidence of psychiatric disorder that significantly interferes with daily living
5. Active suicidal ideation
6. Type 1 diabetes or type 2 diabetes or A1C > 6.5%
7. 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
8. Psychiatric hospitalization within the past 6 months
9. Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
10. Self-reported use of illicit drugs within the past 30 days
11. Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
12. Loss of ≥ 10 lb of body weight within the past 3 months
13. History of (or plans for) bariatric surgery
14. Visual, auditory, or other impairment that would affect task performance
15. Epilepsy or other brain injury
16. Participation in individual psychotherapy for BED in the prior 3 months
17. Inability to attend treatment and lack of capacity to provide informed consent
18. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): June 23, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: obesity; cognitive behavioral therapy; binge eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Body Weight; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Overweight
• Other Study ID Numbers: 829018; 5K23NR017209-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No