Binge-Eating Disorder, Bulimia Nervosa
Conditions
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.
Interventions
BEHAVIORALCBT
Participants will complete 12 sessions of CBT
BEHAVIORALICT
Participants will complete 4 weeks of daily inhibitory control trainings and booster ICT trainings following CBT treatment in weeks 5-12
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigators, therapists, and graduate student assessors will be blinded to treatment condition. The only staff member who cannot be blinded to condition is the study coordinator; she will be aware of condition because of managing randomization and assisting participants in the downloading of the intervention to participants' computers.
Intervention model description
Participants will be randomly assigned to the ICT or ICT sham condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Go/No-Go (GNG) | Change from baseline to post-treatment and 3-month follow up | Performance on the Go/No-Go computer task will be used to assess changes in inhibitory control |
| Laboratory Sham Taste Test | Change from baseline to post-treatment and 3-month follow up | 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 |
Countries
United States
Contacts
Primary ContactLindsay Gillikin, BA
Outcome results
None listed