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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948217
Recruitment Status : Completed
First Posted : May 13, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Eating Disorder Other: Circadian Lighting regimen Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single 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 : July 31, 2018
Actual Study Completion Date : August 31, 2018

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




Primary Outcome Measures :
  1. 3 week change in total score of Major Depression Inventory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 week change as a measure of weight change ]
    change in Body Mass index

  2. 3 week change in Visual analogue scale of mood [ Time Frame: 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 [ Time Frame: 3 weeks change from baseline ]
    urinary levels of melatonin

  4. 3 week change in serotonin levels [ Time Frame: 3 weeks change from baseline ]
    Blood levels of serotonin

  5. 3 week change in cortisol levels [ Time Frame: 3 weeks change from baseline ]
    Urinary levels of cortisol as a measure of stress



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948217


Locations
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Denmark
Mental Health Center
Ballerup, Capitol Region, Denmark, 2750
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Aalborg University
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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    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All patient data
Supporting Materials: Study Protocol
Time Frame: within 12 months
Access Criteria: open

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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:
artificial lighting
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive