Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
研究概览
简要总结
Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 55 years old
- •Binge eating disorders or other eating disorders according to DSM V criteria
- •Patient with BES score (with " Bing Eating Scale " ) > 18
- •Patient with BMI > 18.5 kg/m2
- •Patient who agrees to be included in the study and who signs the informed consent form
- •Patient affiliated to a healthcare insurance plan
排除标准
- •Patients with other psychiatric comorbidities, including a disorder bipolar mood
- •Unstabilized diabetic patient with or retinopathy
- •Patient with sleep disorder (delay or phase inversion)
- •Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
- •Recent eye surgery or eye problem preventing exposure to bright light.
- •Medication making the skin more sensitive to light (eg. Tablets against malaria)
- •Patient who does not understand French/is unable to give consent
- •Mentally unbalanced patients, under supervision or guardianship
- •Patient already included in a research study
- •Pregnancy or desire to be pregnant during the study
研究组 & 干预措施
High intensity light therapy
Treatment with light therapy in high intensity (10,000 lux)
干预措施: High intensity bright light therapy (Device)
Low intensity light therapy
Treatment with light therapy in low intensity (<500 lux)
干预措施: Low intensity light therapy (Device)
结局指标
主要结局
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
时间窗: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
次要结局
- Characteristics of hyperphagic access (duration of crisis)(Day 60)
- Characteristics of hyperphagic access (severity of the disorder)(Day 60)
- Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)(Day 30)
- Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment(Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0))
- Characteristics of hyperphagic access ( evolution of factors triggering)(Day 60)
- Evolution of attentional cognitive profiles and impulsivity(Day 60)
- Characteristics of hyperphagic access (amount of food ingested )(Day 60)
- Symptomatic development of BED(Day 60)
- Evolution of other psychological parameters related to BED(Day 60)
- Evolution of appetite for different categories of food(Day 60)
- Biological parameters may be impacted or mediated by part of the treatment efficiency(Day 30)
- Weight (kilogramm)(Day 60)
- Observance rate to light therapy(day1 to day30)
- Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment(Day-7 to Day-1 period compared to Day23 to Day30 period)
- Characteristics of hyperphagic access (severity of the disorder)(Day 0)
- Characteristics of hyperphagic access (severity of the disorder)(Day 30)
- Characteristics of hyperphagic access (duration of crisis)(Day 0)
- Characteristics of hyperphagic access (duration of crisis)(Day 30)
- Characteristics of hyperphagic access (amount of food ingested )(Day 0)
- Characteristics of hyperphagic access (amount of food ingested )(Day 30)
- Characteristics of hyperphagic access ( evolution of factors triggering)(Day 0)
- Characteristics of hyperphagic access ( evolution of factors triggering)(Day 30)
- Symptomatic development of BED(Day 0)
- Symptomatic development of BED(Day 30)
- Evolution of other psychological parameters related to BED(Day 0)
- Evolution of other psychological parameters related to BED(Day 30)
- Evolution of attentional cognitive profiles and impulsivity(Day 0)
- Evolution of attentional cognitive profiles and impulsivity(Day 30)
- Evolution of appetite for different categories of food(Day 0)
- Evolution of appetite for different categories of food(Day 30)
- Biological parameters may be impacted or mediated by part of the treatment efficiency(Day 0)
- Weight (kilogramm)(Day 0)
- Weight (kilogramm)(Day 30)