Anorexia Nervosa, Eating Disorder
Conditions
Keywords
artificial lighting
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)
Interventions
OTHERCircadian Lighting regimen
Circadian lighting regimen with one major fluctuation, high light intensity and color
Sponsors
Aalborg University
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients are unaware of the type of Circadian lighting regimen that is provided
Intervention model description
Single blind, cross-over, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 3 week change in serotonin levels | 3 weeks change from baseline | Blood levels of serotonin |
| 3 week change in BMI | 3 week change as a measure of weight change | change in Body Mass index |
| 3 week change in cortisol levels | 3 weeks change from baseline | Urinary levels of cortisol as a measure of stress |
| 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 week change in melatonin levels | 3 weeks change from baseline | urinary levels of melatonin |
Countries
Denmark
Outcome results
None listed