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

Sponsor
Mental Health Services in the Capital Region, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03948217
Collaborator
Aalborg University (Other)
11
1
2
4
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Circadian Lighting regimen
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single blind, cross-over, controlledSingle blind, cross-over, controlled
Masking:
Double (Participant, Care Provider)
Masking Description:
Patients are unaware of the type of Circadian lighting regimen that is provided
Primary Purpose:
Treatment
Official Title:
The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Aug 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

Secondary Outcome Measures

  1. 3 week change in BMI [3 week change as a measure of weight change]

    change in Body Mass index

  2. 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. 3 week change in melatonin levels [3 weeks change from baseline]

    urinary levels of melatonin

  4. 3 week change in serotonin levels [3 weeks change from baseline]

    Blood levels of serotonin

  5. 3 week change in cortisol levels [3 weeks change from baseline]

    Urinary levels of cortisol as a measure of stress

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Center Ballerup Capitol Region Denmark 2750

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier:
NCT03948217
Other Study ID Numbers:
  • H-17022914
First Posted:
May 13, 2019
Last Update Posted:
Aug 16, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mental Health Services in the Capital Region, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2019