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Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

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ClinicalTrials.gov Identifier: NCT04076553
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Drexel University

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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Bulimia Nervosa Behavioral: CBT Behavioral: ICT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to the ICT or ICT sham condition.
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Active Comparator: CBT + ICT
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.
Behavioral: CBT
Participants will complete 12 sessions of CBT

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

Sham Comparator: CBT + sham
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.
Behavioral: CBT
Participants will complete 12 sessions of CBT




Primary Outcome Measures :
  1. Eating Disorder Examination (EDE) [ Time Frame: Change from baseline to 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076553


Contacts
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Contact: Lindsay Gillikin, BA 215-553-7110 EDresearch@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lindsay Gillikin, BA    215-553-7110    EDresearch@drexel.edu   
Sponsors and Collaborators
Drexel University
Investigators
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Principal Investigator: Stephanie Manasse, PhD Drexel University

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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT04076553     History of Changes
Other Study ID Numbers: 1904007136
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms