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

Not Applicable

Terminated

• Conditions: Eating Disorder; Anorexia Nervosa
• Interventions: Other: Circadian Lighting regimen

• Registration Number: NCT03948217
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief Summary

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

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)

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS)
2. Age ≥18 and <65

Exclusion Criteria

1. Forced care
2. Non-primary psychiatric disorder other than AN, BN, or EDNOS
3. Binge Eating disorder
4. Somatic unstable condition
5. High suicidal behavior or risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L1	Circadian Lighting regimen	regimen L1 has overall higher intensity, higher color temperature and less light fluctuations
L2	Circadian Lighting regimen	regimen L2 has lower intensity, lower color temperature and more light fluctuations.

Primary Outcome Measures

Name	Time	Method
3 week change in total score of Major Depression Inventory	3 weeks change from baseline	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 week change in video images based measure of Physical activity	3 weeks change in physical activity from baseline	video images based measure of quantity of physical activity
3 week change in total score of Eating Disorder Inventory 2	3 weeks change from baseline	Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mental Health Center; 🇩🇰 Ballerup, Capitol Region, Denmark