Project BITE: Binge Intervention Target Effectiveness

Binge-Eating Disorder Clinical Trial

Official title:

An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113669
• Other study ID #: 1608004727
• Status: Completed
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: August 2018
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

Description:

Binge eating disorder (BED) is characterized by reoccurring binge eating episodes that consist of eating a subjectively or objectively large amount of food over a period of time accompanied by a sense of loss control over eating, in the absence of recurrent compensatory behaviors (e.g., purging). Cognitive behavioral therapy (CBT) is the current gold-standard treatment for reducing binge eating episodes in BED patients. The first-line of recommended CBT treatment is a self-guided intervention called CBT-Guided Self-Help (CBT-GSH). However, for a substantial minority of patients, CBT-GSH fails to reduce binge episodes after treatment. Preliminary findings of the literature suggests that individuals with BED possess deficits in inhibitory control as it relates to food-stimuli. We are studying how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

This study involves a brief phone screen and research assessment (approximately 5 hours) to determine eligibility. Eligible participants will receive CBT-GSH, which will include a one-hour clinical intake followed by 6 therapy sessions (approximately 30 minutes each). Participants will also complete research assessments at mid-treatment, post-treatment, and 3 month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and a task using functional Near Infrared Spectroscopy (fNIR) imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Speak, write, and understand English

• Body Mass Index (BMI) of 30 kg/m2 or greater

• Experience objectively or subjectively large binge eating episodes once per week or more for the past three months

• If applicable, have stable psychiatric medication for the past three months

• For the optional ecological momentary assessment, participants must own a smartphone compatible with PACO mobile application

Exclusion Criteria:

• Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)

• Acute suicide risk

• Are currently receiving psychological treatment for binge eating

• Are currently receiving weight loss treatment

• Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)

• Diagnosis of intellectual disability or autism spectrum disorder

• History of neurological condition or traumatic brain injury

• Current pregnancy

• History of bariatric surgery

• Are currently using a stimulant medication

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• CBT-GSH

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorder Examination (EDE)	The Eating Disorder Examination is a widely utilized, semi-structured interview for the assessment of eating disorder symptoms and the binge-eating module will be used to determine binge episode frequency.	Change from baseline to 3-month follow-up