Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
研究概览
简要总结
The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the impact of CBT on neural responses to binge eating stimuli.
详细描述
Females with a BMI>/=25 kg/m2 and BED will be randomized to either a 16-week, one-on-one CBT intervention (n=20) or a waitlist control (WL; n=20). Both groups will have blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. During the scans, participants will complete the following tasks: 1) food-specific stop signal task (SST), and 2) script-driven imagery of binge foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
- •Ages 18 to 45 years of age
- •BMI >/=25 kg/m2
- •Premenopausal
- •Able to provide informed consent
- •Right-handed
- •Eligible female patients will be:
- •Non-pregnant, evidenced by a negative urine dipstick pregnancy test
- •Non-lactating
- •Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study
- •Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
排除标准
- •Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
- •Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
- •Pregnant or nursing (or plans to become pregnant in the next 5 months)
- •Evidence of psychiatric disorder that significantly interferes with daily living
- •Active suicidal ideation
- •Type 1 diabetes or type 2 diabetes or A1C > 6.5%
- •Use of weight loss medications or other agents known to affect body weight (e.g., oral glucocorticoids, second-generation antipsychotic medications) in the past 3 months
- •Psychiatric hospitalization within the past 6 months
- •Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
- •Self-reported use of illicit drugs within the past 30 days
- •Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- •Loss of ≥ 10 lb of body weight within the past 3 months
- •History of (or plans for) bariatric surgery
- •Visual, auditory, or other impairment that would affect task performance
- •Epilepsy or other brain injury
- •Participation in individual psychotherapy for BED in the prior 3 months
- •Inability to attend treatment and lack of capacity to provide informed consent
- •Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
研究组 & 干预措施
Cognitive behavioral therapy
16-week cognitive behavioral therapy intervention for binge eating disorder
干预措施: Cognitive behavioral therapy (Behavioral)
Waitlist control
16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy
干预措施: Waitlist (Behavioral)
结局指标
主要结局
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
时间窗: Change from baseline to 16 weeks
BOLD fMRI (neural) response to high-calorie food cues during the food-specific stop-signal task in reward regions of interest. Reward-regions included BOLD response of the combination of prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery
时间窗: Change from baseline to 16 weeks
BOLD fMRI response to descriptions of binge eating episodes during script-driven imagery (contrast in reward-regions of interest between food vs neutral stimuli). Reward-regions included combination of BOLD response in the prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum.
次要结局
- Binge Eating Episodes(Change from baseline to 16 weeks)
- Reward-based Eating Drive(Change from baseline to 16 weeks)
- Dietary Disinhibition(Change from baseline to 16 weeks)