Clinical trial NCT03604172: Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Official title: Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Overweight and Obesity
Keywords: binge eating disorder
obesity
cognitive behavioral therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-07-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
timeFrame: Change from baseline to 16 weeks
measure: Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery
timeFrame: Change from baseline to 16 weeks
Secondary outcomes:
measure: Binge Eating Episodes
timeFrame: Change from baseline to 16 weeks
measure: Reward-based Eating Drive
timeFrame: Change from baseline to 16 weeks
measure: Dietary Disinhibition
timeFrame: Change from baseline to 16 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ariana M Chao, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References: