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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

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.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Obesity Behavioral: Cognitive behavioral therapy Behavioral: Waitlist Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : April 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Cognitive behavioral therapy
16-week cognitive behavioral therapy intervention for binge eating disorder
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.

Waitlist control
16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy
Behavioral: Waitlist
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Binge eating episodes [ Time Frame: Change from baseline to 16 weeks ]
    Percent reduction and categorical response measured from the Eating Disorder Examination Questionnaire

  2. Reward-based eating drive [ Time Frame: Change from baseline to 16 weeks ]
    Self-report measured from the Reward-Based Eating Drive Scale

  3. Dietary disinhibition [ Time Frame: Change from baseline to 16 weeks ]
    Self-report measured from the Eating Inventory Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 >/=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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604172


Contacts
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Contact: Ariana M Chao, PhD, CRNP 215-746-7183 arichao@nursing.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ariana M Chao, PhD, CRNP    215-746-7183    arichao@nursing.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Ariana M Chao, PhD, CRNP University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03604172     History of Changes
Other Study ID Numbers: 829018
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
binge eating disorder
obesity
cognitive behavioral therapy

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms