- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113669
Project BITE: Binge Intervention Target Effectiveness
An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Intervention (CBT-GSH)
Participants will receive a clinical intake (1 hour) and 6-sessions (approximately 25 minutes each) over 12 weeks of individual guided self-help CBT for eating disorders based on the treatment approach developed by Dr. Christopher Fairburn to use his self-help book Overcoming Binge Eating with the therapeutic guidance of clinician.
Participants will be provided with a copy of Overcoming Binge Eating.
The treatment is a largely behavioral treatment that focuses on helping patients engage in more regular eating, reduce dieting behaviors, and eliminate behaviors that contribute to binge eating.
All participants in the study will receive the same treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Disorder Examination (EDE)
Time Frame: Change from baseline to 3-month follow-up
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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.
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Change from baseline to 3-month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1608004727
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Binge-Eating Disorder
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University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
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ShireCompleted
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Lindner Center of HOPEUniversity of CincinnatiCompleted
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Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
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Nova Scotia Health AuthorityCompletedBinge-Eating Disorder | Eating DisorderCanada
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University of Southern CaliforniaNot yet recruitingBinge-Eating Disorder
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Alexandria UniversityActive, not recruitingBinge Eating DisorderEgypt
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Heidelberg UniversitySelfapy GmbHCompleted
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Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedBinge-Eating DisorderUnited States
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Nova Scotia Health AuthorityCompletedBinge Eating DisorderCanada
Clinical Trials on CBT-GSH
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Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH); Noom Inc.; Kaiser Foundation Hospitals...CompletedBulimia Nervosa | Binge Eating DisorderUnited States
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Icahn School of Medicine at Mount SinaiKaiser Permanente; Noom Inc.Completed
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University of WashingtonMichael J. Fox Foundation for Parkinson's ResearchCompleted
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Bastyr UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed
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Emory UniversityYour Energy Systems, LLCWithdrawn
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University of MinnesotaCystic Fibrosis FoundationCompletedCystic FibrosisUnited States
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University of SheffieldRecruiting
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Swiss Transfusion SRCCerus CorporationWithdrawn
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Milton S. Hershey Medical CenterCompleted
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Bastyr UniversityMichael J. Fox Foundation for Parkinson's ResearchCompletedParkinson's DiseaseUnited States