NCT03604172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

June 19, 2018

Results QC Date

October 26, 2022

Last Update Submit

March 23, 2023

Conditions

Binge Eating DisorderOverweight and Obesity

Keywords

binge eating disorderobesitycognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

  • 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

    Change from baseline to 16 weeks

  • 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.

    Change from baseline to 16 weeks

Secondary Outcomes (3)

  • Binge Eating Episodes

    Change from baseline to 16 weeks

  • Reward-based Eating Drive

    Change from baseline to 16 weeks

  • Dietary Disinhibition

    Change from baseline to 16 weeks

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

16-week cognitive behavioral therapy intervention for binge eating disorder

Behavioral: Cognitive behavioral therapy

Waitlist control

OTHER

16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy

Behavioral: Waitlist

Interventions

Cognitive behavioral therapyBEHAVIORAL

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.

Cognitive behavioral therapy
WaitlistBEHAVIORAL

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

Waitlist control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Chao AM, Agarwal K, Zhou Y, Grilo CM, Gur RC, Joseph P, Shinohara RT, Richmond TS, Wadden TA. Neural Responses to Auditory Food Stimuli Following Cognitive Behavioral Therapy for Binge-Eating Disorder. Int J Eat Disord. 2024 Sep;57(9):1911-1923. doi: 10.1002/eat.24244. Epub 2024 Jul 2.

    PMID: 38953334DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderOverweightObesity

Interventions

Cognitive Behavioral TherapyWaiting Lists

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Dr. Ariana Chao
Organization
University of Pennsylvania
arichao@upenn.edu
215-746-7183

Study Officials

  • Ariana M Chao, PhD, CRNP

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 27, 2018

Study Start

August 8, 2018

Primary Completion

June 23, 2021

Study Completion

November 22, 2021

Last Updated

April 18, 2023

Results First Posted

April 18, 2023

Record last verified: 2023-03

Locations

US(1)