Bulimia Nervosa Clinical Trial
Official title:
Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
NCT number | NCT04076553 |
Other study ID # | 1904007136 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2019 |
Est. completion date | July 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Drexel University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University |
United States,
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 |
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