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Completed

NCT Number: NCT03113669

Project BITE: Binge Intervention Target Effectiveness

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-GSH

Behavioral

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2017
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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