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

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ClinicalTrials.gov Identifier: NCT03604172
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE August 8, 2018
Estimated Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) response to food-specific stop-signal task [ Time Frame: Change from baseline to 16 weeks ]
    BOLD fMRI response to high-calorie food cues during the food-specific stop-signal task
  • Blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) response to binge-eating script-driven imagery [ Time Frame: Change from baseline to 16 weeks ]
    BOLD fMRI response to descriptions of binge eating episodes during script-driven imagery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03604172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Binge eating episodes [ Time Frame: Change from baseline to 16 weeks ]
    Percent reduction and categorical response measured from the Eating Disorder Examination Questionnaire
  • Reward-based eating drive [ Time Frame: Change from baseline to 16 weeks ]
    Self-report measured from the Reward-Based Eating Drive Scale
  • Dietary disinhibition [ Time Frame: Change from baseline to 16 weeks ]
    Self-report measured from the Eating Inventory Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Official Title  ICMJE Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Eating Disorder
  • Obesity
Intervention  ICMJE
  • 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.
  • Behavioral: Waitlist
    The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
Study Arms  ICMJE
  • Experimental: Cognitive behavioral therapy
    16-week cognitive behavioral therapy intervention for binge eating disorder
    Intervention: Behavioral: Cognitive behavioral therapy
  • Waitlist control
    16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy
    Intervention: Behavioral: Waitlist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 4, 2021
Estimated Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ariana M Chao, PhD, CRNP 215-746-7183 arichao@nursing.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604172
Other Study ID Numbers  ICMJE 829018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ariana M Chao, PhD, CRNP University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP