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Completed

NCT Number: NCT03094260

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

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).

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High intensity bright light therapy

Device

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.

Low intensity light therapy

Device

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 outcomes

  1. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment

    Time frame: 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 outcomes

  1. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment

    Time frame: Day-7 to Day-1 period compared to Day23 to Day30 period

    The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day

  2. Characteristics of hyperphagic access (severity of the disorder)

    Time frame: Day 0

    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  3. Characteristics of hyperphagic access (severity of the disorder)

    Time frame: Day 30

    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  4. Characteristics of hyperphagic access (severity of the disorder)

    Time frame: Day 60

    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  5. Characteristics of hyperphagic access (duration of crisis)

    Time frame: Day 0

    Evaluation of the duration,by the crisis agenda.

  6. Characteristics of hyperphagic access (duration of crisis)

    Time frame: Day 30

    Evaluation of the duration,by the crisis agenda.

  7. Characteristics of hyperphagic access (duration of crisis)

    Time frame: Day 60

    Evaluation of the duration,by the crisis agenda.

  8. Characteristics of hyperphagic access (amount of food ingested )

    Time frame: Day 0

    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  9. Characteristics of hyperphagic access (amount of food ingested )

    Time frame: Day 30

    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  10. Characteristics of hyperphagic access (amount of food ingested )

    Time frame: Day 60

    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  11. Characteristics of hyperphagic access ( evolution of factors triggering)

    Time frame: Day 0

    Evaluation of the factors triggering by the "START" scale.

  12. Characteristics of hyperphagic access ( evolution of factors triggering)

    Time frame: Day 30

    Evaluation of the factors triggering by the "START" scale.

  13. Characteristics of hyperphagic access ( evolution of factors triggering)

    Time frame: Day 60

    Evaluation of the factors triggering by the "START" scale.

  14. Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)

    Time frame: 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.

  15. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment

    Time frame: 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

  16. Symptomatic development of BED

    Time frame: Day 0

    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

  17. Symptomatic development of BED

    Time frame: Day 30

    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

  18. Symptomatic development of BED

    Time frame: 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

  19. Evolution of other psychological parameters related to BED

    Time frame: Day 0

    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

  20. Evolution of other psychological parameters related to BED

    Time frame: Day 30

    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

  21. Evolution of other psychological parameters related to BED

    Time frame: 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

  22. Evolution of attentional cognitive profiles and impulsivity

    Time frame: Day 0

    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

  23. Evolution of attentional cognitive profiles and impulsivity

    Time frame: Day 30

    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

  24. Evolution of attentional cognitive profiles and impulsivity

    Time frame: 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

  25. Evolution of appetite for different categories of food

    Time frame: Day 0

    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/

  26. Evolution of appetite for different categories of food

    Time frame: Day 30

    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/

  27. Evolution of appetite for different categories of food

    Time frame: 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/

  28. Biological parameters may be impacted or mediated by part of the treatment efficiency

    Time frame: Day 0

    Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3

  29. Biological parameters may be impacted or mediated by part of the treatment efficiency

    Time frame: Day 30

    Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3

  30. Weight (kilogramm)

    Time frame: Day 0

    Weight will be expressed in absolute value

  31. Weight (kilogramm)

    Time frame: Day 30

    Weight will be expressed in absolute value

  32. Weight (kilogramm)

    Time frame: Day 60

    Weight will be expressed in absolute value

  33. Observance rate to light therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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