search
Back to results

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

Primary Purpose

Anorexia Nervosa, Eating Disorder

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Circadian Lighting regimen
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring artificial lighting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

L1

L2

Arm Description

regimen L1 has overall higher intensity, higher color temperature and less light fluctuations

regimen L2 has lower intensity, lower color temperature and more light fluctuations.

Outcomes

Primary Outcome Measures

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 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 week change in video images based measure of Physical activity
video images based measure of quantity of physical activity

Secondary Outcome Measures

3 week change in BMI
change in Body Mass index
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 week change in melatonin levels
urinary levels of melatonin
3 week change in serotonin levels
Blood levels of serotonin
3 week change in cortisol levels
Urinary levels of cortisol as a measure of stress

Full Information

First Posted
May 3, 2019
Last Updated
October 18, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Aalborg University
search

1. Study Identification

Unique Protocol Identification Number
NCT03948217
Brief Title
The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder
Acronym
METROPOLIS
Official Title
The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
changes to buildings why study was terminated prematurely
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Aalborg University

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Eating Disorder
Keywords
artificial lighting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single blind, cross-over, controlled
Masking
ParticipantCare Provider
Masking Description
Patients are unaware of the type of Circadian lighting regimen that is provided
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L1
Arm Type
Active Comparator
Arm Description
regimen L1 has overall higher intensity, higher color temperature and less light fluctuations
Arm Title
L2
Arm Type
Active Comparator
Arm Description
regimen L2 has lower intensity, lower color temperature and more light fluctuations.
Intervention Type
Other
Intervention Name(s)
Circadian Lighting regimen
Intervention Description
Circadian lighting regimen with one major fluctuation, high light intensity and color
Primary Outcome Measure Information:
Title
3 week change in total score of Major Depression Inventory
Description
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.
Time Frame
3 weeks change from baseline
Title
3 week change in total score of Eating Disorder Inventory 2
Description
Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.
Time Frame
3 weeks change from baseline
Title
3 week change in video images based measure of Physical activity
Description
video images based measure of quantity of physical activity
Time Frame
3 weeks change in physical activity from baseline
Secondary Outcome Measure Information:
Title
3 week change in BMI
Description
change in Body Mass index
Time Frame
3 week change as a measure of weight change
Title
3 week change in Visual analogue scale of mood
Description
self assessed measure of mood symptoms, range 1-10. Higher score means more symptoms and feeling worse.
Time Frame
3 weeks change from baseline
Title
3 week change in melatonin levels
Description
urinary levels of melatonin
Time Frame
3 weeks change from baseline
Title
3 week change in serotonin levels
Description
Blood levels of serotonin
Time Frame
3 weeks change from baseline
Title
3 week change in cortisol levels
Description
Urinary levels of cortisol as a measure of stress
Time Frame
3 weeks change from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mental Health Center
City
Ballerup
State/Province
Capitol Region
ZIP/Postal Code
2750
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All patient data
IPD Sharing Time Frame
within 12 months
IPD Sharing Access Criteria
open

Learn more about this trial

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

We'll reach out to this number within 24 hrs