The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder

Study Overview
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Brief Summary
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The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED). Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. The rationale of this study is to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED. Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms. Planned number of subjects: 16 patients with a ICD-10 diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.

Detailed Description
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The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED). If an effect is indicated, the study will provide information on how to improve light exposure to ED patients in psychiatric treatment units. In addition, the outcomes may help identify a better system for measurement and adjustment of the specific light variables of colour temperature and light intensity. Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. This is the rationale to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED. Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms. Planned number of subjects: 16 patients with a International Classification of Disorders 10 (ICD-10) diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order. Location: Mental Health Center Ballerup, department 14 (currently Department 5). Diagnostic inventory: Eating Disorder Examination-Questionnaire (EDE-Q)

Official Title
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The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study

Conditions
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Anorexia Nervosa, Eating Disorder

Intervention / Treatment
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* Other: Circadian Lighting regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS) Age ≥18 and <65 Exclusion Criteria: Forced care Non-primary psychiatric disorder other than AN, BN, or EDNOS Binge Eating disorder Somatic unstable condition High suicidal behavior or risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single blind, cross-over, controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L1<br>regimen L1 has overall higher intensity, higher color temperature and less light fluctuations | Other: Circadian Lighting regimen<br>* Circadian lighting regimen with one major fluctuation, high light intensity and color<br>|
| Active Comparator: L2<br>regimen L2 has lower intensity, lower color temperature and more light fluctuations. | Other: Circadian Lighting regimen<br>* Circadian lighting regimen with one major fluctuation, high light intensity and color<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 week change in total score of Major Depression Inventory | depression scoring, change in total score over three weeks. range 0-50. Higher values means more depressed. Mild depression: MDI total score from 21 to 25. Moderate depression: MDI total score from 26 to 30. Severe depression: MDI total score of 31 or higher. | 3 weeks change from baseline | 
| 3 week change in total score of Eating Disorder Inventory 2 | Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms. | 3 weeks change from baseline | 
| 3 week change in video images based measure of Physical activity | video images based measure of quantity of physical activity | 3 weeks change in physical activity from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 week change in BMI | change in Body Mass index | 3 week change as a measure of weight change | 
| 3 week change in Visual analogue scale of mood | self assessed measure of mood symptoms, range 1-10. Higher score means more symptoms and feeling worse. | 3 weeks change from baseline | 
| 3 week change in melatonin levels | urinary levels of melatonin | 3 weeks change from baseline | 
| 3 week change in serotonin levels | Blood levels of serotonin | 3 weeks change from baseline | 
| 3 week change in cortisol levels | Urinary levels of cortisol as a measure of stress | 3 weeks change from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial lighting