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Understanding Everyday Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05502575
Recruitment Status : Recruiting
First Posted : August 16, 2022
Last Update Posted : October 10, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of California, Merced
Stony Brook University
Oregon State University
Information provided by (Responsible Party):
Joshua Smyth, 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.

Condition or disease Intervention/treatment Phase
Stress Psychological Stress Behavioral: Self-monitoring and personalized stress management Behavioral: Self-monitoring and general stress management Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes 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.
Primary Purpose: Treatment
Official Title: Everyday Stress Response Targets in the Science of Behavior Change
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Self-monitoring and individualized stress management
Self-monitoring and individualized stress management materials available on a smartphone.
Behavioral: Self-monitoring and personalized stress management
Self-monitoring and personalized stress management education and materials.

Active Comparator: Self-monitoring and general stress management
Self-monitoring and general stress management materials available on a smartphone.
Behavioral: Self-monitoring and general stress management
Self-monitoring and general stress management education and materials.




Primary Outcome Measures :
  1. Stress responses in everyday life [ Time Frame: 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 :
  1. Activity behaviors - time spent sitting [ Time Frame: 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.

  2. Activity behaviors - time spent standing [ Time Frame: 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.

  3. Activity behaviors - time spent in light physical activity [ Time Frame: 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.

  4. Activity behaviors - time spent in moderate or vigorous physical activity [ Time Frame: 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.

  5. Activity behaviors - total step count [ Time Frame: 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.

  6. Activity behaviors - total sit-stand transitions [ Time Frame: 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.

  7. Activity behaviors - meets recommended moderate-vigorous activity recommendation threshold [ Time Frame: 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).

  8. Sleep - total sleep time [ Time Frame: 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.

  9. Sleep - wake after sleep onset [ Time Frame: 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.

  10. Sleep - sleep efficiency [ Time Frame: 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.

  11. Sleep - meets recommended sleep recommendation [ Time Frame: 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.


Other Outcome Measures:
  1. Mood [ Time Frame: Changes from baseline to post-intervention (one month later) ]

    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).


  2. Stress [ Time Frame: Changes from baseline to post-intervention (one month later) ]
    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.

  3. Perceived Stress [ Time Frame: Changes from baseline to post-intervention (one month later) ]
    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

  4. Stress-related thoughts [ Time Frame: Changes from baseline to post-intervention (one month later) ]
    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.

  5. Stress mindset [ Time Frame: Changes from baseline to post-intervention (one month later) ]
    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.

  6. Social support [ Time Frame: Changes from baseline to post-intervention (one month later) ]

    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.


  7. Insomnia symptoms [ Time Frame: Changes from baseline to post-intervention (one month later) ]

    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.


  8. Reported sleep quality [ Time Frame: Changes from baseline to post-intervention (one month later) ]
    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).

  9. Reported physical activity [ Time Frame: Changes from baseline to post-intervention (one month later) ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05502575


Contacts
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Contact: Principal Investigator 814-863-8402 jms1187@psu.edu
Contact: Study Director 814-863-7256 jaj53@psu.edu

Locations
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United States, Pennsylvania
Stress, Health, and Daily Experiences Laboratory Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Joshua M Smyth, PhD    814-863-8402    jms1187@psu.edu   
Contact: Jillian A Johnson, PhD    8148637256    jaj53@psu.edu   
Sub-Investigator: David M Almedia, PhD         
Sub-Investigator: Martin J Sliwinski, PhD         
Sub-Investigator: Orfeu M Buxton, PhD         
Sub-Investigator: David E Conroy, PhD         
Sub-Investigator: Christopher Sciamanna, MD         
Sponsors and Collaborators
Penn State University
National Institute on Aging (NIA)
University of California, Merced
Stony Brook University
Oregon State University
Investigators
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Principal Investigator: Joshua M Smyth, PhD Penn State University
Study Director: Jillian A Johnson, PhD Penn State University
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Responsible Party: Joshua Smyth, Distinguished Professor, Penn State University
ClinicalTrials.gov Identifier: NCT05502575    
Other Study ID Numbers: UH3AG052167 ( U.S. NIH Grant/Contract )
UH3AG052167 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2022    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Analytic Code
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.
Access Criteria: Non-commercial research purposes only. Data must be requested and cited appropriately.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Smyth, Penn State University:
Stress
Stress Management
Health Behaviors
Experimental Medicine
Science of Behavior Change
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms