Project BITE: Binge Intervention Target Effectiveness

NCT03113669 | Completed

• 1 other identifier: 1608004727
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention (CBT-GSH)

OTHER

Participants will receive a clinical intake (1 hour) and 6-sessions (approximately 25 minutes each) over 12 weeks of individual guided self-help CBT for eating disorders based on the treatment approach developed by Dr. Christopher Fairburn to use his self-help book Overcoming Binge Eating with the therapeutic guidance of clinician. Participants will be provided with a copy of Overcoming Binge Eating. The treatment is a largely behavioral treatment that focuses on helping patients engage in more regular eating, reduce dieting behaviors, and eliminate behaviors that contribute to binge eating. All participants in the study will receive the same treatment.

Behavioral: CBT-GSH

Interventions

CBT-GSH BEHAVIORAL

Intervention (CBT-GSH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Parker MN, Burton Murray H, Piers AD, Muratore A, Lowe MR, Manasse SM, Ayaz H, Juarascio AS. Prefrontal cortex activation by binge-eating status in individuals with obesity while attempting to reappraise responses to food using functional near infrared spectroscopy. Eat Weight Disord. 2023 Mar 30;28(1):34. doi: 10.1007/s40519-023-01558-z.

  PMID: 36995567 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: October 6, 2016
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)