Sleep Extension to Improve Mood in Young Urban Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are:
Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution?
Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups.
Participants will:
- receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content
- have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period
- respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 30
- •Have internalizing symptoms (e.g., depression, anxiety, stress)
- •Have sleep concerns
- •Sleep less than 7 hours per night
- •Have perceived neighborhood disorder
- •Smart phone that can run Somnofy app
- •Access to Wifi in their home
排除标准
- •High risk for obstructive sleep apnea
- •Significant medical morbidities or psychiatric problem, or chronic substance use
- •Non-English speaking (unable to participate in therapy or questionnaire)
- •Taking medications for sleep
- •An insomnia disorder
- •Traveling for 2 weeks or more during the 10-week study period (due to loss of data from participants not sleeping in their home where the Somnofy device has been set up)
- •Employed with rotating shift or night work
研究组 & 干预措施
Sleep Extension
Sleep-related psychoeducation will be provided in weekly lesson content. Phone coaching will revolve around sleep health and meeting sleep goals.
干预措施: Sleep Extension (Behavioral)
Healthy Living
Psychoeducation about general health (e.g., hand washing) will be provided in weekly lesson content. Phone coaches will not provide counseling or goal setting but may clarify terms or concepts.
干预措施: Healthy Living Psychoeducation (Behavioral)
结局指标
主要结局
Feasibility
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by the number of participants approached, recruited and retained
Tolerability
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by sessions completed
Acceptability
时间窗: At end of 6-week intervention
Acceptability of Intervention Measure
Sleep duration
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by Fitbit
Sleep efficiency
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by Fitbit
Waking after sleep onset (WASO)
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by Fitbit
Subjective sleep quality
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured with the Pittsburgh Sleep Quality Index (PSQI), where higher scores indicate poorer sleep quality.
Internalizing symptoms
时间窗: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Anxiety, depression, and stress as measured with the Depression, Anxiety and Stress Scale - 21 item (DASS-21), where higher scores mean more distress.
次要结局
- Daytime fatigue(From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention))
- Bedtime Procrastination(From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention))
- Electronics use before bed(Pre-treatment and at 6-week post-treatment assessment)