Phototherapy in Young People With Depression
Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1Z 7K4
- 招聘中
- Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
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接触：
- Rébecca Robillard, PhD
- 电话号码：6279 +1 613 722 6521
- 邮箱：reb.robillard@gmail.com
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New South Wales
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Camperdown、New South Wales、澳大利亚、2050
- 暂停
- Brain and Mind Research Insitute, The University of Sydney
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Phototherapy
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The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times. Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention. During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of Depression
大体时间：Between baseline and post (4 weeks) intervention
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Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Between baseline and post (4 weeks) intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of Depression
大体时间：Score between baseline and follow up (8 weeks)
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Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Score between baseline and follow up (8 weeks)
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Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
大体时间：Between baseline and post (4 weeks) intervention
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Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Between baseline and post (4 weeks) intervention
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Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
大体时间：Baseline and post (4 weeks) intervention
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Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Baseline and post (4 weeks) intervention
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Subjective Sleep Quality
大体时间：Between baseline and post (4 weeks) intervention
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Change in Leeds Sleep Evaluation Questionnaire score
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Between baseline and post (4 weeks) intervention
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Fatigue Severity
大体时间：Between baseline and post (4 weeks) intervention
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Change in Fatigue Severity Scale score
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Between baseline and post (4 weeks) intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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