Understanding Everyday Stress

Phase 2

Completed

• Conditions: Stress; Psychological Stress
• Interventions: Behavioral: Self-monitoring and personalized stress management; Behavioral: Self-monitoring and general stress management

• Registration Number: NCT05502575
• Lead Sponsor: Penn State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2022-08-12
• Study Start: 2022-08-15
• Study First Posted: 2022-08-16
• Primary Completion: 2023-06-09
• Study Completion: 2023-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

1. Men or women between the ages of 35-65 years
2. Capable of reading, understanding, and speaking English and providing written informed consent
3. Free of visual and motor impairment that would interfere with the use of a smartphone
4. In good general health, ambulatory, and free of functional activity limitations
5. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

1. Diagnosed mental health condition that required a medication adjustment or hospitalization within the last 3 months
2. Primary caretaker for a parent or severely disabled child/family member
3. Inability to answer Smartphone survey messages received throughout the day due to restrictions or policies in the workplace
4. Employment that requires work between the hours of 10pm and 6am or overnight 'on-call'
5. Known allergic reactions to surgical adhesive tape
6. 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
7. Inability to be physically active or who have medical contradictions for physical activity
8. 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
9. Use of physician prescribed sleep aids/pharmaceuticals or over the counter sleep aids for 3 or more days per week
10. Living in same household as a current or former participant
11. Unwilling to travel to the study site for in-person visits
12. Travelling for an extended period of time when scheduled for study participation or unwilling to return for in-person visit subsequently

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-monitoring and individualized stress management	Self-monitoring and personalized stress management	Self-monitoring and individualized stress management materials available on a smartphone.
Self-monitoring and general stress management	Self-monitoring and general stress management	Self-monitoring and general stress management materials available on a smartphone.

Primary Outcome Measures

Name	Time	Method
Stress responses in everyday life	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).

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
Sleep - sleep efficiency	Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.	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.
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.	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.
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.	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.
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.	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).
Sleep - total sleep time	Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.	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.
Sleep - meets recommended sleep recommendation	Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.	Categorical variable denotes whether a participant achieved a Total Sleep Time at least seven hours of sleep on a given day.
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.	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.
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.	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.
Sleep - wake after sleep onset	Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.	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.

Trial Locations

Locations (1)

Stress, Health, and Daily Experiences Laboratory; 🇺🇸 University Park, Pennsylvania, United States