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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03604172
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 39.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder; Overweight and Obesity	Behavioral: Cognitive behavioral therapy; Behavioral: Waitlist	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
• Actual Study Start Date: Aug 8, 2018
• Actual Primary Completion Date: Jun 23, 2021
• Actual Study Completion Date: Nov 22, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 response to high-calorie food cues during the food-specific stop-signal task

2. 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

Secondary Outcome Measures

1. Binge eating episodes [Change from baseline to 16 weeks]

   Percent reduction and categorical response measured from the Eating Disorder Examination Questionnaire

2. Reward-based eating drive [Change from baseline to 16 weeks]

   Self-report measured from the Reward-Based Eating Drive Scale

3. Dietary disinhibition [Change from baseline to 16 weeks]

   Self-report measured from the Eating Inventory Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Ariana M Chao, PhD, CRNP, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03604172
• Other Study ID Numbers: 829018
• First Posted: Jul 27, 2018
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Pennsylvania: binge eating disorder; obesity; cognitive behavioral therapy
• Additional relevant MeSH terms: Disease; Overweight; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder

Study Results

No Results Posted as of Dec 3, 2021