The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- 3 week change in total score of Major Depression Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients are unaware of the type of Circadian lighting regimen that is provided
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS)
- •Age ≥18 and <65
排除标准
- •Forced care
- •Non-primary psychiatric disorder other than AN, BN, or EDNOS
- •Binge Eating disorder
- •Somatic unstable condition
- •High suicidal behavior or risk
结局指标
主要结局
3 week change in total score of Major Depression Inventory
时间窗: 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
时间窗: 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
时间窗: 3 weeks change from baseline
Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.
次要结局
- 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)