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Clinical Trials/NCT04076553
NCT04076553
Unknown
Not Applicable

Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training

Drexel University1 site in 1 country60 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge-Eating Disorder
Sponsor
Drexel University
Enrollment
60
Locations
1
Primary Endpoint
Eating Disorder Examination (EDE)
Last Updated
4 years ago

Overview

Brief Summary

The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.

Detailed Description

This study involves a brief phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 12 sessions of CBT treatment and will be randomly assigned to an ICT or ICT sham condition which will consist of completing ICT computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. 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 behavioral tasks.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
July 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age 18-55
  • meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
  • be stable on psychiatric medications for at least 3 months

Exclusion Criteria

  • have a diagnosis of anorexia nervosa or a BMI \< 18.5
  • have extreme malnutrition or other medical complications that require acute hospitalization
  • are at acute suicide risk
  • are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
  • have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating Disorder
  • have a diagnosis of an intellectual disability or autism spectrum disorder
  • currently taking stimulant medications
  • score of 95% or higher on 550ms block of Go/No-Go assessment task, indicating high inhibitory control at Baseline

Outcomes

Primary Outcomes

Eating Disorder Examination (EDE)

Time Frame: Change in binge frequency from baseline to post-treatment and 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.

Secondary Outcomes

  • Food Frequency Questionnaire (FFQ)(Change from baseline to post-treatment and 3-month follow up)

Study Sites (1)

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