Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Project BITE: Binge Intervention Target Effectiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113669
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Drexel University

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

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Behavioral: CBT-GSH Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating
Actual Study Start Date : October 6, 2016
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Intervention (CBT-GSH)
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



Primary Outcome Measures :
  1. Eating Disorder Examination (EDE) [ Time Frame: Change from baseline to 3-month follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113669


Locations
Layout table for location information
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University

Layout table for additonal information
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03113669     History of Changes
Other Study ID Numbers: 1608004727
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms