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Understanding Everyday Stress

Primary Purpose

Stress, Psychological Stress

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-monitoring and personalized stress management
Self-monitoring and general stress management
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Stress, Stress Management, Health Behaviors, Experimental Medicine, Science of Behavior Change

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stress, Health, and Daily Experiences Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-monitoring and individualized stress management

Self-monitoring and general stress management

Arm Description

Self-monitoring and individualized stress management materials available on a smartphone.

Self-monitoring and general stress management materials available on a smartphone.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.

Full Information

First Posted
September 2, 2019
Last Updated
August 7, 2023
Sponsor
Penn State University
Collaborators
National Institute on Aging (NIA), University of California, Merced, Stony Brook University, Oregon State University
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1. Study Identification

Unique Protocol Identification Number
NCT05502575
Brief Title
Understanding Everyday Stress
Official Title
Everyday Stress Response Targets in the Science of Behavior Change
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute on Aging (NIA), University of California, Merced, Stony Brook University, Oregon State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological Stress
Keywords
Stress, Stress Management, Health Behaviors, Experimental Medicine, Science of Behavior Change

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-monitoring and individualized stress management
Arm Type
Experimental
Arm Description
Self-monitoring and individualized stress management materials available on a smartphone.
Arm Title
Self-monitoring and general stress management
Arm Type
Active Comparator
Arm Description
Self-monitoring and general stress management materials available on a smartphone.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring and personalized stress management
Intervention Description
Self-monitoring and personalized stress management education and materials.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring and general stress management
Intervention Description
Self-monitoring and general stress management education and materials.
Primary Outcome Measure Information:
Title
Stress responses in everyday life
Description
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).
Time Frame
Assessed daily for 4 weeks. Changes in stress responses from prior to intervention to during the intervention period.
Secondary Outcome Measure Information:
Title
Activity behaviors - time spent sitting
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - time spent standing
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - time spent in light physical activity
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - time spent in moderate or vigorous physical activity
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - total step count
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - total sit-stand transitions
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Activity behaviors - meets recommended moderate-vigorous activity recommendation threshold
Description
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).
Time Frame
Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.
Title
Sleep - total sleep time
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Title
Sleep - wake after sleep onset
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Title
Sleep - sleep efficiency
Description
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.
Time Frame
Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Title
Sleep - meets recommended sleep recommendation
Description
Categorical variable denotes whether a participant achieved a Total Sleep Time at least seven hours of sleep on a given day.
Time Frame
Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Other Pre-specified Outcome Measures:
Title
Mood
Description
12-item instrument utilizing mood items derived from the Positive and Negative Affect Schedule and Circumplex Model of Affect. Items are scored from "not at all" (10) to "extremely" (50) and combined for a score for each subscale corresponding to high and low arousal positive and negative affect (range is 30-150 on each subscale). High activation positive subscale: Higher scores indicate greater levels of high activation positive affect (i.e., happy, enthusiastic, excited). Low activation positive subscale: Higher scores indicate greater levels of low activation positive affect (i.e., relaxed, content, calm). High activation negative subscale: Higher scores indicate greater levels of high activation negative affect (i.e., anxious, annoyed, upset). Low activation negative subscale: Higher scores indicate greater levels of low activation negative affect (i.e., bored, sad, sluggish).
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Stress
Description
Subjective report of recent stress - 6 items assessing presence of stress in past 7 days, including global rating of overall stress, frequency, duration, stressor severity, control over the stressor, predictability, current impact of stress, thoughts about the stressor, reactivity and recovery from the stressor, and ease of recovery following the stress. Higher scores indicate higher level of recent stress.
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Perceived Stress
Description
Assessed by the Perceived Stress Scale; 14 items assessing stress in past 7 days. Items scored from "never" (10) to "very often" (50). Yields total score with all items averaged together. Minimum possible score of 10 and a maximum possible score of 50. Higher scores indicate greater levels of perceived stress
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Stress-related thoughts
Description
Perseverative cognitions measured by 5 items scored from "not at all" (0) to "very much" (100). Yields a total score reflecting the average across all items, with a range of 0-100. Higher scores reflect greater degree of perseverative cognition related to stressful topics.
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Stress mindset
Description
General stress mindset as measured by the 8-item Stress Mindset Measure. Items scored in one-unit increments with values ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The scale yields a total score with all items averaged together, with a range of 1 to 5. Higher scores represent the mindset that stress is enhancing.
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Social support
Description
Social support as measured by 8-items from the Social Support Questionnaire. This scale has 8 items that reflect two sub-scales of 4 items each. Four items enumerate the number of people that fit the question (e.g., "In the past 30 days, how many people could you really count on to help you feel more relaxed when you were under pressure or tense?") with options ranging from 0 to 10. The remaining four items assess reported satisfaction with social support and are scored from "very dissatisfied" (0) to "very satisfied" (100). Subscale scores calculated by averaging the four-item blocks separately: Number subscale: higher scores indicate a greater number of people available to provide social support, with a range of 0 to 10. Satisfaction subscale: higher scores indicate greater levels of availability and/or satisfaction with the social support received from others, with a range of 0 to 100.
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Insomnia symptoms
Description
Insomnia symptom severity as measured using the 7-item Insomnia Severity Index. Items assessing difficulty falling asleep, staying asleep, and problems waking too early assessed on a scale of 0 to 4 ("none", "mild", "moderate", "severe", "very severe") with higher values indicating worse insomnia symptoms. Additional items assess satisfaction with sleep patterns, how noticeable sleep problems are to others, amount of worry or distress about sleep problems, and interference with daily life.
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Reported sleep quality
Description
Pittsburgh Sleep Quality Index is comprised of items that assess overall sleep quality (range "very good" to "very bad"), typical bedtime, minutes to fall asleep, wake time, total sleep time (in hours), feeling rested ("always" to "never"), frequency of medication use for sleep ("not during the last month", "less than once a week", "once or twice a week", "three or more times a week"), causes of sleep problems, and bed sharing. Each item is scored 0-3 and are used to generate a total score ranging from 0 (good sleep) to 21 (impaired sleep).
Time Frame
Changes from baseline to post-intervention (one month later)
Title
Reported physical activity
Description
Multiple aspects of reported physical activity behavior (walking, moderate activity, vigorous activity, sedentary time, and total activity) are assessed using the International Physical Activity Questionnaire - Short Form. Units of measure are median metabolic equivalent of task (MET) minutes. Walking (2 items; range 0 to 33264). Higher values reflect greater durations of time reported spent walking. Moderate intensity activity (2 items; range 0 to 40320). Higher values reflect greater moderate-intensity physical activity. Vigorous intensity activity (2 items; range 0 to 80640). Higher values reflect greater vigorous-intensity physical activity. Total activity (6 items; range 0 to 80640). Total METs = walking METs + moderate-intensity METs + vigorous-intensity METs. Higher values reflect greater intensity-based physical activity. Sedentary time (2 items; range 0 to 1440). Units of measure are minutes. Higher values reflect greater sedentary time.
Time Frame
Changes from baseline to post-intervention (one month later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Smyth, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jillian A Johnson, PhD
Organizational Affiliation
Penn State University
Official's Role
Study Director
Facility Information:
Facility Name
Stress, Health, and Daily Experiences Laboratory
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All available, fully deidentified, IPD will be made available for research (non-commercial) purposes two years subsequent to the conclusion of the trial.
IPD Sharing Time Frame
Fully deidentified data will be made available for research (non-commercial) purposes two years subsequent to the conclusion of the trial. Data will be available for a minimum of five years, although efforts will be made to keep it available as long as possible.
IPD Sharing Access Criteria
Non-commercial research purposes only. Data must be requested and cited appropriately.

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Understanding Everyday Stress

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