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

Not Applicable

Completed

• Conditions: Binge Eating Disorder; Overweight and Obesity
• Interventions: Behavioral: Cognitive behavioral therapy; Behavioral: Waitlist

• Registration Number: NCT03604172
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2018-08-08
• Primary Completion: 2021-06-23
• Study Completion: 2021-11-22
• Results First Submitted: 2022-10-26
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy	Cognitive behavioral therapy	16-week cognitive behavioral therapy intervention for binge eating disorder
Waitlist control	Waitlist	16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy

Primary Outcome Measures

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

Name	Time	Method
Binge Eating Episodes	Change from baseline to 16 weeks	Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Reward-based Eating Drive	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.
Dietary Disinhibition	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States