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临床试验/NCT01064700
NCT01064700已完成1 期

Bright Light: A Novel Treatment for Anxiety

University of South Carolina2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
33
试验地点
2
主要终点
Hamilton Anxiety

研究概览

简要总结

The primary aim of this research was to examine the influence of bright light on anxiety in high-anxious young adults. In an acute exposure study, participants were randomly assigned to 45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after the treatments, state anxiety, mood, and blood pressure were assessed.

Following the acute exposure study, participants performed a 5-week study. Following a a 1-week baseline, participants were randomly assigned to four weeks of daily exposure to either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion generator, which were initiated ≤1 hr after awakening. Before and after the experiment, clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following each week of treatment, blood pressure, as well as questionnaires for state anxiety, depression, mood, sleep, and side effects were assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having a level of trait anxiety [Spielberger State-Trait Anxiety Inventory (Form Y1)]{23642} that was ≥ the 75th percentile for their age (i.e., ≥ 46 and ≥ 44 for women and men, respectively)

排除标准

  • Current treatment for anxiety or depression;
  • History of bipolar disorder, mania, or psychotic disorders;
  • History of winter depression, which might bias towards positive response to light;
  • Hypertension;
  • Ophthalmic abnormalities; and
  • Usual exposure to high levels of light such that the intervention would add little to usual exposure.

结局指标

主要结局

Hamilton Anxiety

时间窗: 5 weeks

Hamilton Anxiety Questionnaire

Spielberger State Anxiety Inventory

时间窗: 5 weeks

state anxiety questionnaire

次要结局

  • Beck Depression Inventory(5 weeks)
  • Pittsburgh Sleep Quality Inventory(5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn Youngstedt

Assistant Professor

University of South Carolina

研究点 (2)

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Bright Light: A Novel Treatment for Anxiety | 临床试验