Understanding Everyday Stress

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 2

Conditions: Psychological Stress; Stress

Treatments: Behavioral: Self-monitoring and personalized stress management; Behavioral: Self-monitoring and general stress management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05502575

UH3AG052167 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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213 participants in 2 patient groups

Self-monitoring and individualized stress management

Experimental group

Description:

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

Treatment:

Behavioral: Self-monitoring and personalized stress management

Self-monitoring and general stress management

Active Comparator group

Description:

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

Treatment:

Behavioral: Self-monitoring and general stress management