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

NCT ID: NCT03604172

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2021-11-22

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.

Conditions

Binge Eating Disorder; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavioral therapy

16-week cognitive behavioral therapy intervention for binge eating disorder

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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 control

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

Group Type: OTHER

Waitlist

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Waitlist

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariana M Chao, PhD, CRNP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Chao AM, Agarwal K, Zhou Y, Grilo CM, Gur RC, Joseph P, Shinohara RT, Richmond TS, Wadden TA. Neural Responses to Auditory Food Stimuli Following Cognitive Behavioral Therapy for Binge-Eating Disorder. Int J Eat Disord. 2024 Sep;57(9):1911-1923. doi: 10.1002/eat.24244. Epub 2024 Jul 2.

Reference Type: DERIVED

PMID: 38953334 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5K23NR017209-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

829018

Identifier Type: -

Identifier Source: org_study_id