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



Status:Recruiting
Conditions:Obesity Weight Loss, Psychiatric, Eating Disorder
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:9/13/2018
Start Date:August 8, 2018
End Date:April 4, 2021
Contact:Ariana M Chao, PhD, CRNP
Email:arichao@nursing.upenn.edu
Phone:215-746-7183

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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.

Females who are obese with 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.

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 >/=30 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
We found this trial at
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-746-7183
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