Everyday Stress Response Targets in the Science of Behavior Change
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Stress responses in everyday life
研究概览
简要总结
This research study is being done to better understand how people experience stress in everyday life and how that stress may relate to sleep and physical activity. We are also testing stress management approaches that are intended to reduce stress responses in everyday life.
详细描述
This research study is being done to better understand how people experience stress in everyday life and how that stress may relate to sleep and physical activity. We are also testing stress management approaches that are intended to reduce stress responses in everyday life.
This study asks participants to carry and use a study-provided smartphone to answer brief surveys during daily life for several weeks. On these surveys, participants will self-report their stress, mood, thoughts, physical activity, and sleep patterns, as well as a few other questions about where they are and what they are doing at each survey. Study participants will also wear two commercial devices on their person; one that tracks physical activity and the other sleep. Information about stress management will also be provided to participants on the study smartphone. At the end of the study, participants will be asked to return the smartphone and devices and will receive compensation for their time and effort.
The overall aim of this study is to determine the effectiveness of two stress management interventions, both delivered via the study smartphone, on the outcomes of stress responses, sleep, and physical activity.
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, Care Provider, Outcomes Assessor)
盲法说明
Participants, research staff, and outcome assessors will be blind to condition assignment and to specific details of the intervention. Investigators will be blind to condition assignment until the conclusion of data collection.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women between the ages of 35-65 years
- •Capable of reading, understanding, and speaking English and providing written informed consent
- •Free of visual and motor impairment that would interfere with the use of a smartphone
- •In good general health, ambulatory, and free of functional activity limitations
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Diagnosed mental health condition that required a medication adjustment or hospitalization within the last 3 months
- •Primary caretaker for a parent or severely disabled child/family member
- •Inability to answer Smartphone survey messages received throughout the day due to restrictions or policies in the workplace
- •Employment that requires work between the hours of 10pm and 6am or overnight 'on-call'
- •Known allergic reactions to surgical adhesive tape
- •Self-reported or medical diagnosis of sleep apnea, score above threshold on the STOP-BANG screening, or self-reported use of a C-PAP machine
- •Inability to be physically active or who have medical contradictions for physical activity
- •Self-report of physical exercise of 200 minutes or more per week at a moderate or vigorous intensity, or 10 or more hours of walking per week
- •Use of physician prescribed sleep aids/pharmaceuticals or over the counter sleep aids for 3 or more days per week
- •Living in same household as a current or former participant
- •Unwilling to travel to the study site for in-person visits
- •Travelling for an extended period of time when scheduled for study participation or unwilling to return for in-person visit subsequently
研究组 & 干预措施
Self-monitoring and individualized stress management
Self-monitoring and individualized stress management materials available on a smartphone.
干预措施: Self-monitoring and personalized stress management (Behavioral)
Self-monitoring and general stress management
Self-monitoring and general stress management materials available on a smartphone.
干预措施: Self-monitoring and general stress management (Behavioral)
结局指标
主要结局
Stress responses in everyday life
时间窗: Assessed daily for 4 weeks. Changes in stress responses from prior to intervention to during the intervention period.
Our primary outcome assessment is psychological stress responses in everyday life. To characterize subjective stress response, we utilize brief assessments of stress response indicators that encompass three aspects of the stress response in everyday life. First, we assess change in subjective stress indicators from non-stressed resting state to immediately after experiencing a stressor (i.e., stress reactivity). Second, we assess recovery in subjective stress indicators from stress following exposure as indexed by the degree to which the individual returns to their non-stressed resting state following stress reactivity. Third, as stress responses may occur in isolation or repeatedly, we characterize the number of stress responses over time (the sum of observed stress response cycles in a 48-hr interval).
次要结局
- Activity behaviors - total sit-stand transitions(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - total step count(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Sleep - sleep efficiency(Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - time spent sitting(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - time spent in light physical activity(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - meets recommended moderate-vigorous activity recommendation threshold(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Sleep - total sleep time(Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.)
- Sleep - meets recommended sleep recommendation(Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - time spent standing(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Activity behaviors - time spent in moderate or vigorous physical activity(Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.)
- Sleep - wake after sleep onset(Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.)
研究者
Joshua Smyth
Distinguished Professor
Penn State University