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Project BITE: Binge Intervention Target Effectiveness

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-GSH
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention (CBT-GSH)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2017
Last Updated
August 14, 2018
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT03113669
Brief Title
Project BITE: Binge Intervention Target Effectiveness
Official Title
An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (CBT-GSH)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-GSH
Primary Outcome Measure Information:
Title
Eating Disorder Examination (EDE)
Description
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.
Time Frame
Change from baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Project BITE: Binge Intervention Target Effectiveness

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