Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Binge-Eating Disorder, Bulimia Nervosa

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: ICT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to the ICT or ICT sham condition.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT + ICT<br>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<br>* Participants will complete 12 sessions of CBT<br>Behavioral: ICT<br>* Participants will complete 4 weeks of daily inhibitory control trainings and booster ICT trainings following CBT treatment in weeks 5-12<br>|
| Sham Comparator: CBT + sham<br>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<br>* Participants will complete 12 sessions of CBT<br>|

What is the study measuring?
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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 |