Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
Primary Purpose
Binge-Eating Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High intensity bright light therapy
Low intensity light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Binge-Eating Disorder
Eligibility Criteria
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
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
Sites / Locations
- HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High intensity light therapy
Low intensity light therapy
Arm Description
Treatment with light therapy in high intensity (10,000 lux)
Treatment with light therapy in low intensity (<500 lux)
Outcomes
Primary Outcome Measures
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Secondary Outcome Measures
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)
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
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Symptomatic development of BED
The symptomatic development of BED will be measured by evaluating :
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
Symptomatic development of BED
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
Symptomatic development of BED
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
The evolution of other psychological parameters will be measured by evaluating the composite :the 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 other psychological parameters related to BED
The evolution of other psychological parameters will be measured by evaluating the composite the 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 other psychological parameters related to BED
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 attentional cognitive profiles and impulsivity
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
Evolution of attentional cognitive profiles and impulsivity
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
Evolution of attentional cognitive profiles and impulsivity
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
Evolution of appetite for different categories of food
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/
Evolution of appetite for different categories of food
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/
Evolution of appetite for different categories of food
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
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Biological parameters may be impacted or mediated by part of the treatment efficiency
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Weight (kilogramm)
Weight will be expressed in absolute value
Weight (kilogramm)
Weight will be expressed in absolute value
Weight (kilogramm)
Weight will be expressed in absolute value
Observance rate to light therapy
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03094260
Brief Title
Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
Official Title
Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
April 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity light therapy
Arm Type
Experimental
Arm Description
Treatment with light therapy in high intensity (10,000 lux)
Arm Title
Low intensity light therapy
Arm Type
Placebo Comparator
Arm Description
Treatment with light therapy in low intensity (<500 lux)
Intervention Type
Device
Intervention Name(s)
High intensity bright light therapy
Intervention Description
Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.
Intervention Type
Device
Intervention Name(s)
Low intensity light therapy
Intervention Description
Treatment with light therapy in low intensity (<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.
Primary Outcome Measure Information:
Title
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
Description
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Time Frame
Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
Secondary Outcome Measure Information:
Title
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
Description
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Time Frame
Day-7 to Day-1 period compared to Day23 to Day30 period
Title
Characteristics of hyperphagic access (severity of the disorder)
Description
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Time Frame
Day 0
Title
Characteristics of hyperphagic access (severity of the disorder)
Description
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Time Frame
Day 30
Title
Characteristics of hyperphagic access (severity of the disorder)
Description
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Time Frame
Day 60
Title
Characteristics of hyperphagic access (duration of crisis)
Description
Evaluation of the duration,by the crisis agenda.
Time Frame
Day 0
Title
Characteristics of hyperphagic access (duration of crisis)
Description
Evaluation of the duration,by the crisis agenda.
Time Frame
Day 30
Title
Characteristics of hyperphagic access (duration of crisis)
Description
Evaluation of the duration,by the crisis agenda.
Time Frame
Day 60
Title
Characteristics of hyperphagic access (amount of food ingested )
Description
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Time Frame
Day 0
Title
Characteristics of hyperphagic access (amount of food ingested )
Description
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Time Frame
Day 30
Title
Characteristics of hyperphagic access (amount of food ingested )
Description
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Time Frame
Day 60
Title
Characteristics of hyperphagic access ( evolution of factors triggering)
Description
Evaluation of the factors triggering by the "START" scale.
Time Frame
Day 0
Title
Characteristics of hyperphagic access ( evolution of factors triggering)
Description
Evaluation of the factors triggering by the "START" scale.
Time Frame
Day 30
Title
Characteristics of hyperphagic access ( evolution of factors triggering)
Description
Evaluation of the factors triggering by the "START" scale.
Time Frame
Day 60
Title
Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)
Description
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.
Time Frame
Day 30
Title
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
Description
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Time Frame
Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)
Title
Symptomatic development of BED
Description
The symptomatic development of BED will be measured by evaluating :
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
Time Frame
Day 0
Title
Symptomatic development of BED
Description
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
Time Frame
Day 30
Title
Symptomatic development of BED
Description
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
Time Frame
Day 60
Title
Evolution of other psychological parameters related to BED
Description
The evolution of other psychological parameters will be measured by evaluating the composite :the 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
Time Frame
Day 0
Title
Evolution of other psychological parameters related to BED
Description
The evolution of other psychological parameters will be measured by evaluating the composite the 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
Time Frame
Day 30
Title
Evolution of other psychological parameters related to BED
Description
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
Time Frame
Day 60
Title
Evolution of attentional cognitive profiles and impulsivity
Description
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
Time Frame
Day 0
Title
Evolution of attentional cognitive profiles and impulsivity
Description
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
Time Frame
Day 30
Title
Evolution of attentional cognitive profiles and impulsivity
Description
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
Time Frame
Day 60
Title
Evolution of appetite for different categories of food
Description
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/
Time Frame
Day 0
Title
Evolution of appetite for different categories of food
Description
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/
Time Frame
Day 30
Title
Evolution of appetite for different categories of food
Description
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/
Time Frame
Day 60
Title
Biological parameters may be impacted or mediated by part of the treatment efficiency
Description
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Time Frame
Day 0
Title
Biological parameters may be impacted or mediated by part of the treatment efficiency
Description
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Time Frame
Day 30
Title
Weight (kilogramm)
Description
Weight will be expressed in absolute value
Time Frame
Day 0
Title
Weight (kilogramm)
Description
Weight will be expressed in absolute value
Time Frame
Day 30
Title
Weight (kilogramm)
Description
Weight will be expressed in absolute value
Time Frame
Day 60
Title
Observance rate to light therapy
Description
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
Time Frame
day1 to day30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane MORFIN, MD
Organizational Affiliation
Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
We'll reach out to this number within 24 hrs