Clinical trial NCT05502575: Understanding Everyday Stress
Official title: Everyday Stress Response Targets in the Science of Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Psychological Stress
Keywords: Stress
Stress Management
Health Behaviors
Experimental Medicine
Science of Behavior Change
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of California, Merced
name: Stony Brook University
name: Oregon State University
First posted: 2022-08-16
Enrollment: 213
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress responses in everyday life
timeFrame: Assessed daily for 4 weeks. Changes in stress responses from prior to intervention to during the intervention period.
Secondary outcomes:
measure: Activity behaviors - time spent sitting
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - time spent standing
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - time spent in light physical activity
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - time spent in moderate or vigorous physical activity
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - total step count
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - total sit-stand transitions
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Activity behaviors - meets recommended moderate-vigorous activity recommendation threshold
timeFrame: Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
measure: Sleep - total sleep time
timeFrame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
measure: Sleep - wake after sleep onset
timeFrame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
measure: Sleep - sleep efficiency
timeFrame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
measure: Sleep - meets recommended sleep recommendation
timeFrame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Other outcomes:
measure: Mood
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Stress
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Perceived Stress
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Stress-related thoughts
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Stress mindset
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Social support
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Insomnia symptoms
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Reported sleep quality
timeFrame: Changes from baseline to post-intervention (one month later)
measure: Reported physical activity
timeFrame: Changes from baseline to post-intervention (one month later)
Locations:
city: University Park
country: United States
facility: Stress, Health, and Daily Experiences Laboratory
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Joshua M Smyth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Jillian A Johnson, PhD
role: STUDY_DIRECTOR
References: