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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604172
• Other study ID #: 829018
• Secondary ID: 5K23NR017209-03
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: November 22, 2021

Study information

• Verified date: March 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 22, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders
• Overweight
• Overweight and Obesity

Intervention

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.
• Waitlist
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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