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Completed

NCT Number: NCT03604172

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Behavioral

The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.

Primary outcomes

  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 (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

  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 (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 outcomes

  1. Binge Eating Episodes

    Time frame: Change from baseline to 16 weeks

    Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.

  2. Reward-based Eating Drive

    Time frame: Change from baseline to 16 weeks

    Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.

  3. Dietary Disinhibition

    Time frame: Change from baseline to 16 weeks

    Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2018
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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