Clinical trial NCT04076553: Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training
Official title: Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Binge-Eating Disorder
Bulimia Nervosa
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the ICT or ICT sham condition.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eating Disorder Examination (EDE)
timeFrame: Change in binge frequency from baseline to post-treatment and 3-month follow-up
Secondary outcomes:
measure: Food Frequency Questionnaire (FFQ)
timeFrame: Change from baseline to post-treatment and 3-month follow up
Other outcomes:
measure: Go/No-Go (GNG)
timeFrame: Change from baseline to post-treatment and 3-month follow up
measure: Laboratory Sham Taste Test
timeFrame: Change from baseline to post-treatment and 3-month follow up
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Stephanie Manasse, PhD
role: PRINCIPAL_INVESTIGATOR
References: