Light Therapy and Binge Eating Disorder Treatment (BED Light Study)

Not Applicable

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Device: Low intensity light therapy; Device: High intensity bright light therapy

• Registration Number: NCT03094260
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-29
• Study Start: 2018-03-29
• Primary Completion: 2020-04-09
• Study Completion: 2020-04-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity light therapy	Low intensity light therapy	Treatment with light therapy in low intensity (\<500 lux)
High intensity light therapy	High intensity bright light therapy	Treatment with light therapy in high intensity (10,000 lux)

Primary Outcome Measures

Name	Time	Method
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment	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

Secondary Outcome Measures

Name	Time	Method
Characteristics of hyperphagic access (duration of crisis)	Day 60	Evaluation of the duration,by the crisis agenda.
Characteristics of hyperphagic access (severity of the disorder)	Day 60	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)	Day 30	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale. Evaluation of the duration, the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda. Evaluation of the factors triggering by the "START" scale.
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)	The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Characteristics of hyperphagic access ( evolution of factors triggering)	Day 60	Evaluation of the factors triggering by the "START" scale.
Evolution of attentional cognitive profiles and impulsivity	Day 60	The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task
Characteristics of hyperphagic access (amount of food ingested )	Day 60	Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Symptomatic development of BED	Day 60	The symptomatic development of BED will be measured by evaluating the composite: * The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire; * The Body concerns based on the "Body sharpe" questionnaire; * The Addiction to food from the Yale Food Addiction scale; * The Diet-related impulsivity from the Three-Factor Eating Questionnaire
Evolution of other psychological parameters related to BED	Day 60	The evolution of other psychological parameters will be measured by evaluating the composite mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale
Evolution of appetite for different categories of food	Day 60	The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/
Biological parameters may be impacted or mediated by part of the treatment efficiency	Day 30	Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Weight (kilogramm)	Day 60	Weight will be expressed in absolute value
Observance rate to light therapy	day1 to day30	The assessment of the adherence rate will be quantified by the average number of lux received over the 30 days of treatment. The exposure (expressed in lux number / session) in lux will be measured and recorded using a luxmeter

Trial Locations

Locations (1)

HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon); 🇫🇷 Bron, France