StressPhase 2NCT05502575
Understanding Everyday Stress
A Phase 2 study testing Self-monitoring and personalized stress management and Self-monitoring and general stress management in people with Stress and Psychological Stress, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological Stress
- What is being tested?
- Self-monitoring and personalized stress management and Self-monitoring and general stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 14 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stress, Health, and Daily Experiences Laboratory
University Park, Pennsylvania, 16802
About this study
Official title: Everyday Stress Response Targets in the Science of Behavior Change
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.
Read the 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.
- Conditions
- Stress, Psychological Stress
- Being tested
- Self-monitoring and personalized stress management, Self-monitoring and general stress management
- Keywords
- Stress, Stress Management, Health Behaviors, Experimental Medicine, Science of Behavior Change
- Medical subject headings
- Stress, Psychological, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring and personalized stress managementBehavioural
Self-monitoring and personalized stress management education and materials.
Self-monitoring and general stress managementBehavioural
Self-monitoring and general stress management education and materials.
| Study group | Role | What they receive |
|---|---|---|
| Self-monitoring and individualized stress management | Experimental | Self-monitoring and individualized stress management materials available on a smartphone. Receives: Behavioral: Self-monitoring and personalized stress management |
| Self-monitoring and general stress management | Active comparator | Self-monitoring and general stress management materials available on a smartphone. Receives: Behavioral: Self-monitoring and general stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed daily for 4 weeks. Changes in stress responses from prior to intervention to during the intervention period.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Aug 2022
- Primary completion9 Jun 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, Merced, Stony Brook University, Oregon State University
- Responsible party
- Principal investigator, Joshua Smyth, Penn State University
- Investigators
- Joshua M Smyth, PhD, Principal investigator, Penn State UniversityJillian A Johnson, PhD, Study director, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502575
- Sponsor's protocol ID
- UH3AG052167
- Other IDs
- UH3AG052167
- Status last verified
- Aug 2023
- First submitted
- 2 Sep 2019
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All available, fully deidentified, IPD will be made available for research (non-commercial) purposes two years subsequent to the conclusion of the trial.
Publications
Johnson JA, Zawadzki MJ, Sliwinski MJ, Almeida DM, Buxton OM, Conroy DE, Marcusson-Clavertz D, Kim J, Stawski RS, Scott SB, Sciamanna CN, Green PA, Repka EM, Toledo MJL, Sturges NL, Smyth JM. Adaptive Just-in-Time Intervention to Reduce Everyday Stress Responses: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 22;14:e58985. doi: 10.2196/58985.
PubMed 39842791
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everyday Stress Response Targets in the Science of Behavior Change
- ClinicalTrials.gov ID
- NCT05502575
- Acronym / sponsor ID
- UH3AG052167
- Conditions
- Stress, Psychological Stress
- Keywords
- Stress, Stress Management, Health Behaviors, Experimental Medicine, Science of Behavior Change
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, Merced, Stony Brook University, Oregon State University
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.
| Arm | Type | Receives |
|---|---|---|
| Self-monitoring and individualized stress management | Experimental | Behavioral: Self-monitoring and personalized stress managementSelf-monitoring and individualized stress management materials available on a smartphone. |
| Self-monitoring and general stress management | Active comparator | Behavioral: Self-monitoring and general stress managementSelf-monitoring and general stress management materials available on a smartphone. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-monitoring and personalized stress managementSelf-monitoring and personalized stress management education and materials. | Behavioural | Self-monitoring and individualized stress management |
| Self-monitoring and general stress managementSelf-monitoring and general stress management education and materials. | Behavioural | Self-monitoring and general stress management |
Primary outcome
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).
11 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Sleep - total sleep time
Time frame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
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.
Sleep - sleep efficiency
Time frame: Assessed daily for 4 weeks. Changes in sleep behaviors from prior to intervention to during the intervention period.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 39842791Johnson JA, Zawadzki MJ, Sliwinski MJ, Almeida DM, Buxton OM, Conroy DE, Marcusson-Clavertz D, Kim J, Stawski RS, Scott SB, Sciamanna CN, Green PA, Repka EM, Toledo MJL, Sturges NL, Smyth JM. Adaptive Just-in-Time Intervention to Reduce Everyday Stress Responses: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 22;14:e58985. doi: 10.2196/58985.
- Individual participant dataSharing planned: Yes. All available, fully deidentified, IPD will be made available for research (non-commercial) purposes two years subsequent to the conclusion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua M Smyth, PhD principal investigator
Penn State University
Jillian A Johnson, PhD study director
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-monitoring and personalized stress management and Self-monitoring and general stress management in people with Stress and Psychological Stress, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.