Understanding Everyday Stress

NCT05502575 | Completed Phase 2 DMC

• 1 other identifier: UH3AG052167
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Psychological Stress

Keywords

Stress; Stress Management; Health Behaviors; Experimental Medicine; Science of Behavior Change

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  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

  Assessed daily for 4 weeks. Changes in physical activity and sedentary behaviors from prior to intervention to during the intervention period.

Other Outcomes (9)

• Mood

  Changes from baseline to post-intervention (one month later)

• Stress

  Changes from baseline to post-intervention (one month later)

• Perceived Stress

  Changes from baseline to post-intervention (one month later)

Study Arms (2)

Self-monitoring and individualized stress management

EXPERIMENTAL

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

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.

Behavioral: Self-monitoring and general stress management

Interventions

Self-monitoring and personalized stress management BEHAVIORAL

Self-monitoring and personalized stress management education and materials.

Self-monitoring and individualized stress management

Self-monitoring and general stress management BEHAVIORAL

Self-monitoring and general stress management education and materials.

Self-monitoring and general stress management

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Institute on Aging (NIA): collaborator
• University of California, Merced: collaborator
• Stony Brook University: collaborator
• Oregon State University: collaborator

Study Sites (1)

Stress, Health, and Daily Experiences Laboratory

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 39842791 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Health Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Joshua M Smyth, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Jillian A Johnson, PhD

  Penn State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: A comparative trial of two stress management approaches for the improvement of stress responses, sleep, and physical activity in everyday life.

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: August 16, 2022
• Study Start: August 15, 2022
• Primary Completion: June 9, 2023
• Study Completion: July 14, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)