Back to resultsAugmenting Cognitive Behavioral Therapy With Inhibitory Control Training
Primary Purpose
Binge-Eating Disorder, Bulimia Nervosa
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
ICT
Sponsored by
About this trial
This is an interventional treatment trial for Binge-Eating Disorder
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
Sites / Locations
- Drexel UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
CBT + ICT
CBT + sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04076553
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Bulimia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to the ICT or ICT sham condition.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT + ICT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CBT + sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Participants will complete 12 sessions of CBT
Intervention Type
Behavioral
Intervention Name(s)
ICT
Intervention Description
Participants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12
Primary Outcome Measure Information:
Title
Eating Disorder Examination (EDE)
Description
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.
Time Frame
Change in binge frequency from baseline to post-treatment and 3-month follow-up
Secondary Outcome Measure Information:
Title
Food Frequency Questionnaire (FFQ)
Description
A modified version of the Food Frequency Questionnaire will be used to examine changes in binge eating on specific foods in the last month
Time Frame
Change from baseline to post-treatment and 3-month follow up
Other Pre-specified Outcome Measures:
Title
Go/No-Go (GNG)
Description
Performance on the Go/No-Go computer task will be used to assess changes in inhibitory control
Time Frame
Change from baseline to post-treatment and 3-month follow up
Title
Laboratory Sham Taste Test
Description
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
Time Frame
Change from baseline to post-treatment and 3-month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Gillikin, BA
Phone
215-553-7110
Email
EDresearch@drexel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Manasse, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Gillikin, BA
Phone
215-553-7110
Email
EDresearch@drexel.edu
12. IPD Sharing Statement
Learn more about this trial
Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training
We'll reach out to this number within 24 hrs