Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Bulimia Nervosa
• Intervention / Treatment: Behavioral: CBT; Behavioral: ICT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Gillikin, BA; Phone Number: 215-553-7110; Email: EDresearch@drexel.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Drexel University
      • Contact: Lindsay Gillikin, BA; Phone Number: 215-553-7110; Email: EDresearch@drexel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT + ICT; Participants randomized to the ICT condition will complete a computerized ICT training at home during the first 4 weeks of treatment and ICT "boosters" following their treatment sessions during weeks 5-12.	Behavioral: CBT; Participants will complete 12 sessions of CBT; Behavioral: ICT; Participants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12
Sham Comparator: CBT + sham; Participants randomized to the sham condition will complete a computerized sham ICT training at home during the first 4 weeks of treatment and sham ICT "boosters" following their treatment sessions during weeks 5-12. The shame will contain the same proportion of food as non-food but no inhibitory training component.	Behavioral: CBT; Participants will complete 12 sessions of CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 in binge frequency from baseline to post-treatment and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Frequency Questionnaire (FFQ)	A modified version of the Food Frequency Questionnaire will be used to examine changes in binge eating on specific foods in the last month	Change from baseline to post-treatment and 3-month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Go/No-Go (GNG)	Performance on the Go/No-Go computer task will be used to assess changes in inhibitory control	Change from baseline to post-treatment and 3-month follow up
Laboratory Sham Taste Test	An ecologically valid measure of inhibitory control specific to eating behavior, this task measures the amount of food that a participant consumes during a 10min interval when asked to taste the food presented	Change from baseline to post-treatment and 3-month follow up

Collaborators and Investigators

• Sponsor: Drexel University
• Investigators: Principal Investigator: Stephanie Manasse, PhD, Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 1904007136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No