NCT04076553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

August 30, 2019

Last Update Submit

August 6, 2021

Conditions

Binge-Eating DisorderBulimia Nervosa

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change in binge frequency from baseline to post-treatment and 3-month follow-up

Secondary Outcomes (1)

  • Food Frequency Questionnaire (FFQ)

    Change from baseline to post-treatment and 3-month follow up

Other Outcomes (2)

  • Go/No-Go (GNG)

    Change from baseline to post-treatment and 3-month follow up

  • Laboratory Sham Taste Test

    Change from baseline to post-treatment and 3-month follow up

Study Arms (2)

CBT + ICT

ACTIVE COMPARATOR

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: CBTBehavioral: ICT

CBT + sham

SHAM COMPARATOR

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

Interventions

CBTBEHAVIORAL

Participants will complete 12 sessions of CBT

CBT + ICTCBT + sham
ICTBEHAVIORAL

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

CBT + ICT

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

  • Butler RM, Lampe E, Trainor C, Manasse SM. Fear of weight gain during cognitive behavioral therapy for binge-spectrum eating disorders. Eat Weight Disord. 2023 Mar 6;28(1):29. doi: 10.1007/s40519-023-01541-8.

    PMID: 36879078DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderBulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Stephanie Manasse, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Gillikin, BA

CONTACT

215-553-7110EDresearch@drexel.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to the ICT or ICT sham condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 3, 2019

Study Start

October 15, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

US(1)