Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

Bulimia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076553
• Other study ID #: 1904007136
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Drexel University
• Contact: Lindsay Gillikin, BA
• Phone: 215-553-7110
• Email: EDresearch[@]drexel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Behavioral:
• CBT
Participants will complete 12 sessions of CBT
• ICT
Participants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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