Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Severity of Depression
研究概览
简要总结
Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.
The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quick Inventory of Depressive Symptomatology score > 6;
- •First episode of depression before age 25;
- •Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.
排除标准
- •Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
- •Other primary psychiatric disorders aside from anxiety disorders;
- •Significant alcohol or other substance dependence;
- •Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);
- •Use of medications that may interact with light to produce a photoallergic reaction;
- •Eye or skin condition which may interact with bright light exposure;
- •Regular shift-work within 60-days prior to entry into the study;
- •Recent transmeridian travel.
结局指标
主要结局
Severity of Depression
时间窗: Between baseline and post (4 weeks) intervention
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
次要结局
- Severity of Depression(Score between baseline and follow up (8 weeks))
- Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression(Between baseline and post (4 weeks) intervention)
- Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression(Baseline and post (4 weeks) intervention)
- Subjective Sleep Quality(Between baseline and post (4 weeks) intervention)
- Fatigue Severity(Between baseline and post (4 weeks) intervention)
研究者
Rébecca Robillard
Research Fellow
University of Ottawa