Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

Not Applicable

• Conditions: Binge-Eating Disorder; Bulimia Nervosa
• Interventions: Behavioral: CBT; Behavioral: ICT

• Registration Number: NCT04076553
• Lead Sponsor: Drexel University

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.

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-10-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT + sham	CBT	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.
CBT + ICT	CBT	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.
CBT + ICT	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.

Primary Outcome Measures

Name	Time	Method
Eating Disorder Examination (EDE)	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 Outcome Measures

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

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States