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临床试验/NCT02750631
NCT02750631已完成不适用

Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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