Back to resultsNeural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Primary Purpose
Binge Eating Disorder, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Waitlist
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder focused on measuring binge eating disorder, obesity, cognitive behavioral therapy
Eligibility Criteria
Inclusion Criteria:
- Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
- Ages 18 to 45 years of age
- BMI >/=25 kg/m2
- Premenopausal
- Able to provide informed consent
- Right-handed
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
- 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:
- Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
- Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
- Pregnant or nursing (or plans to become pregnant in the next 5 months)
- Evidence of psychiatric disorder that significantly interferes with daily living
- Active suicidal ideation
- Type 1 diabetes or type 2 diabetes or A1C > 6.5%
- 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
- Psychiatric hospitalization within the past 6 months
- Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
- Self-reported use of illicit drugs within the past 30 days
- Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- Loss of ≥ 10 lb of body weight within the past 3 months
- History of (or plans for) bariatric surgery
- Visual, auditory, or other impairment that would affect task performance
- Epilepsy or other brain injury
- Participation in individual psychotherapy for BED in the prior 3 months
- Inability to attend treatment and lack of capacity to provide informed consent
- 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cognitive behavioral therapy
Waitlist control
Arm Description
16-week cognitive behavioral therapy intervention for binge eating disorder
16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Binge Eating Episodes
Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
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.
Dietary Disinhibition
Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
Full Information
NCT ID
NCT03604172
First Posted
June 19, 2018
Last Updated
March 23, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03604172
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
November 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Overweight and Obesity
Keywords
binge eating disorder, obesity, cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
16-week cognitive behavioral therapy intervention for binge eating disorder
Arm Title
Waitlist control
Arm Type
Other
Arm Description
16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
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
Intervention Name(s)
Waitlist
Intervention Description
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
Primary Outcome Measure Information:
Title
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
Description
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
Time Frame
Change from baseline to 16 weeks
Title
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery
Description
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.
Time Frame
Change from baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Binge Eating Episodes
Description
Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Time Frame
Change from baseline to 16 weeks
Title
Reward-based Eating Drive
Description
Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.
Time Frame
Change from baseline to 16 weeks
Title
Dietary Disinhibition
Description
Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
Time Frame
Change from baseline to 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
Ages 18 to 45 years of age
BMI >/=25 kg/m2
Premenopausal
Able to provide informed consent
Right-handed
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
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:
Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
Pregnant or nursing (or plans to become pregnant in the next 5 months)
Evidence of psychiatric disorder that significantly interferes with daily living
Active suicidal ideation
Type 1 diabetes or type 2 diabetes or A1C > 6.5%
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
Psychiatric hospitalization within the past 6 months
Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
Self-reported use of illicit drugs within the past 30 days
Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
Loss of ≥ 10 lb of body weight within the past 3 months
History of (or plans for) bariatric surgery
Visual, auditory, or other impairment that would affect task performance
Epilepsy or other brain injury
Participation in individual psychotherapy for BED in the prior 3 months
Inability to attend treatment and lack of capacity to provide informed consent
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariana M Chao, PhD, CRNP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
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