Sleep to Activate Mood Promotion- Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index Sum Scores
研究概览
简要总结
The investigators are aiming to examine the acceptability and feasibility of a portable bright light therapy instrument to improve sleep disturbance in a preventive intervention for depression. The investigators will conduct an intervention that trials the use of bright light glasses called "re-timers" as a preventive intervention in older adults with sleep disturbance and subsyndromal symptoms of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older
- •6 or greater on the Pittsburgh Sleep Quality Index
- •A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale
排除标准
- •Active suicidal ideation
- •Presence of mania or bipolar disorder
- •Presence of an eye disease
- •Prescription of a photosensitizing medication
- •Having previously had eye surgery
结局指标
主要结局
Insomnia Severity Index Sum Scores
时间窗: two weeks after introduction of intervention
The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.
Patient Health Questionnaire-9 Depression Scale
时间窗: two weeks after introduction of intervention
The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.
Pittsburgh Sleep Quality Index
时间窗: two weeks after introduction of intervention
The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.
Morningness-Eveningness Questionnaire
时间窗: two weeks after introduction of intervention
The morningness- eveningness categories represent the time of day when a person is at their peak alertness.
次要结局
- Actigraph Sleep Data: Minutes Asleep(daily for 4 weeks- baseline and intervention period)
- Actigraph: Number of Awakenings(daily for 4 weeks- baseline and intervention period)
- Self-Reported Sleep Diary: Night Awakenings(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Time at Which Participants Wake up(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Sleep Quality(daily for 4 weeks- baseline and intervention period to be compared)
- Fitbit Sleep Data: Night Awakenings(daily for 4 weeks- baseline and intervention period)
- Fitbit Sleep Data: Sleep Efficiency(daily for 4 weeks- baseline and intervention period)
- Self-Reported Sleep Diary: Time at Which Participants go to Bed(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Sleep Duration(daily for 4 weeks- baseline and intervention period to be compared)
- Actigraph: Efficiency(daily for 4 weeks- baseline and intervention period)
- Fitbit Sleep Data: Sleep Duration(daily for 4 weeks- baseline and intervention period)
研究者
Amanda Leggett
Postdoctoral Research Fellow
University of Michigan