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

University of Pennsylvania

Status: Completed

Conditions: Overweight and Obesity; Binge Eating Disorder

Treatments: Behavioral: Cognitive behavioral therapy; Behavioral: Waitlist

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03604172

829018

5K23NR017209-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cognitive behavioral therapy

Experimental group

Description:

16-week cognitive behavioral therapy intervention for binge eating disorder

Treatment:

Behavioral: Cognitive behavioral therapy

Waitlist control

Other group

Description:

16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy

Treatment:

Behavioral: Waitlist