Understanding Everyday Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Everyday Stress Response Targets in the Science of Behavior Change

Conditions
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Stress, Psychological Stress

Intervention / Treatment
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* Behavioral: Self-monitoring and personalized stress management
* Behavioral: Self-monitoring and general stress management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-monitoring and individualized stress management<br>Self-monitoring and individualized stress management materials available on a smartphone. | Behavioral: Self-monitoring and personalized stress management<br>* Self-monitoring and personalized stress management education and materials.<br>|
| Active Comparator: Self-monitoring and general stress management<br>Self-monitoring and general stress management materials available on a smartphone. | Behavioral: Self-monitoring and general stress management<br>* Self-monitoring and general stress management education and materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress responses in everyday life | 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). | Assessed daily for 4 weeks. Changes in stress responses from prior to intervention to during the intervention period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity behaviors - time spent sitting | Daily number of waking minutes spent sitting, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | 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 standing | Daily number of waking minutes spent standing, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | 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 | Daily number of waking minutes spent performing light physical activity, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | 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 | Daily number of waking minutes spent performing moderate of vigorous physical activity, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | 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 | Total number of daily steps taken, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period. | 
| Activity behaviors - total sit-stand transitions | Daily number of transitions from sitting to standing, summarized as the daily average for each participant derived from an activPAL 4 accelerometer worn on the midline of the thigh. | 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 | Categorical variable denotes whether a participant achieved 21.5 minutes of MVPA on a given day (derived from a recommended weekly level MVPA is 150 minutes, transformed to compute a daily threshold of recommended MVPA). | 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 | Total number of minutes between sleep onset and final awakening; daily total sleep time (TST) scores will be summarized as the average TST (i.e., the daily average) for each participant. | Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period. | 
| Sleep - wake after sleep onset | Total number of minutes that a participant spent awake between sleep onset and final awakening; daily wake after sleep onset (WASO) scores will be summarized as the average WASO (i.e., the daily average) for each participant. | Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period. | 
| Sleep - sleep efficiency | Daily proportion of Total Sleep Time spent in bed; daily sleep efficiency (SE) scores will be summarized as the average SE (i.e., the daily average) for each participant. | Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period. | 
| Sleep - meets recommended sleep recommendation | Categorical variable denotes whether a participant achieved a Total Sleep Time at least seven hours of sleep on a given day. | Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Stress Management, Health Behaviors, Experimental Medicine, Science of Behavior Change