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

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

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.

Study Overview

• Status: Terminated
• Conditions: Anorexia Nervosa; Eating Disorder
• Intervention / Treatment: Other: Circadian Lighting regimen

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capitol Region
    • Ballerup, Capitol Region, Denmark, 2750
      • Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: artificial lighting
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: H-17022914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All patient data
• IPD Sharing Time Frame: within 12 months
• IPD Sharing Access Criteria: open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No