Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Binge-Eating Disorder Bulimia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to the ICT or ICT sham condition.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

Participants will complete 12 sessions of CBT

ICT

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

CBT

Intervention Type BEHAVIORAL

Participants will complete 12 sessions of CBT

Interventions

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CBT

Participants will complete 12 sessions of CBT

Intervention Type BEHAVIORAL

ICT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No