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
- 1
- 主要终点
- Patient Health Questionnaire-9 Depression Scale
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
研究组 & 干预措施
Bright Light Intervention
Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
干预措施: Re-Timer glasses (Device)
结局指标
主要结局
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.
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.
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