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

Anorexia Nervosa Clinical Trial

— METROPOLIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03948217
• Other study ID #: H-17022914
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Other:
• Circadian Lighting regimen
Circadian lighting regimen with one major fluctuation, high light intensity and color

Locations

Country	Name	City	State
Denmark	Mental Health Center	Ballerup	Capitol Region

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	3 week change in BMI	change in Body Mass index	3 week change as a measure of weight change
Secondary	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
Secondary	3 week change in melatonin levels	urinary levels of melatonin	3 weeks change from baseline
Secondary	3 week change in serotonin levels	Blood levels of serotonin	3 weeks change from baseline
Secondary	3 week change in cortisol levels	Urinary levels of cortisol as a measure of stress	3 weeks change from baseline