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Clinical Trials/NCT03948217
NCT03948217
Terminated
Not Applicable

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

Mental Health Services in the Capital Region, Denmark1 site in 1 country22 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
22
Locations
1
Primary Endpoint
3 week change in total score of Major Depression Inventory
Status
Terminated
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
August 31, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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

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.

Secondary Outcomes

  • 3 week change in melatonin levels(3 weeks change from baseline)
  • 3 week change in cortisol levels(3 weeks change from baseline)
  • 3 week change in BMI(3 week change as a measure of weight change)
  • 3 week change in Visual analogue scale of mood(3 weeks change from baseline)
  • 3 week change in serotonin levels(3 weeks change from baseline)

Study Sites (1)

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