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临床试验/NCT03113669
NCT03113669已完成不适用

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

Drexel University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年10月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Eating Disorder Examination (EDE)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Intervention (CBT-GSH)

Other

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.

干预措施: CBT-GSH (Behavioral)

结局指标

主要结局

Eating Disorder Examination (EDE)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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