Project BITE: Binge Intervention Target Effectiveness
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|ClinicalTrials.gov Identifier: NCT03113669|
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Binge-Eating Disorder||Behavioral: CBT-GSH||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of Appetitive Cognitive Control: Impact on Treat Outcomes for Binge Eating|
|Actual Study Start Date :||October 6, 2016|
|Actual Primary Completion Date :||February 15, 2018|
|Actual Study Completion Date :||February 15, 2018|
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.
- Eating Disorder Examination (EDE) [ Time Frame: Change from baseline to 3-month follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113669
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|