Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 17-item Hamilton Rating Scale for Depression
研究概览
简要总结
Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.
详细描述
Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.
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
盲法说明
All patients and staff know what the treatment is.
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
- •major depressive disorder or persistent depressive disorder or unspecified depressive disorder
- •physically healthy
- •patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination
排除标准
- •medically unstable condition
- •bipolar disorder
- •current (past six months) substance use disorder
- •significant suicide risk
- •need for hospitalization
- •history of psychosis
研究组 & 干预措施
Triple Therapy
Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance
干预措施: Triple Therapy (Other)
结局指标
主要结局
17-item Hamilton Rating Scale for Depression
时间窗: 1 week
The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression
次要结局
未报告次要终点
