Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training

Drexel University

Status: Unknown

Conditions: Binge-Eating Disorder; Bulimia Nervosa

Treatments: Behavioral: CBT; Behavioral: ICT

Study type: Interventional

Funder types: Other

Identifiers

NCT04076553

1904007136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

CBT + ICT

Active Comparator group

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.

Treatment:

Behavioral: ICT

Behavioral: CBT

CBT + sham

Sham Comparator group

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.

Treatment:

Behavioral: CBT