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Project BITE: Binge Intervention Target Effectiveness

An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03113669
Enrollment
20
Registered
2017-04-13
Start date
2016-10-06
Completion date
2018-02-15
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder

Brief summary

The primary aim of this study is to determine how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

Detailed description

Binge eating disorder (BED) is characterized by reoccurring binge eating episodes that consist of eating a subjectively or objectively large amount of food over a period of time accompanied by a sense of loss control over eating, in the absence of recurrent compensatory behaviors (e.g., purging). Cognitive behavioral therapy (CBT) is the current gold-standard treatment for reducing binge eating episodes in BED patients. The first-line of recommended CBT treatment is a self-guided intervention called CBT-Guided Self-Help (CBT-GSH). However, for a substantial minority of patients, CBT-GSH fails to reduce binge episodes after treatment. Preliminary findings of the literature suggests that individuals with BED possess deficits in inhibitory control as it relates to food-stimuli. We are studying how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome. This study involves a brief phone screen and research assessment (approximately 5 hours) to determine eligibility. Eligible participants will receive CBT-GSH, which will include a one-hour clinical intake followed by 6 therapy sessions (approximately 30 minutes each). 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 a task using functional Near Infrared Spectroscopy (fNIR) imaging.

Interventions

BEHAVIORALCBT-GSH

Sponsors

Drexel University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Speak, write, and understand English * Body Mass Index (BMI) of 30 kg/m2 or greater * Experience objectively or subjectively large binge eating episodes once per week or more for the past three months * If applicable, have stable psychiatric medication for the past three months * For the optional ecological momentary assessment, participants must own a smartphone compatible with PACO mobile application

Exclusion criteria

* Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use) * Acute suicide risk * Are currently receiving psychological treatment for binge eating * Are currently receiving weight loss treatment * Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence) * Diagnosis of intellectual disability or autism spectrum disorder * History of neurological condition or traumatic brain injury * Current pregnancy * History of bariatric surgery * Are currently using a stimulant medication

Design outcomes

Primary

MeasureTime frameDescription
Eating Disorder Examination (EDE)Change from baseline to 3-month follow-upThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026