ASR: Acute Stress Recovery

Sponsor
Well Living Lab, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05298189
Collaborator
Mayo Clinic (Other), Delos Living LLC (Other)
100
1
4
17.9
5.6

Study Details

Study Description

Brief Summary

The proposed study aims to evaluate whether different features of a relaxation room affect how individuals recover from acute stress. This study will use a unique methodology to capture participants' physiological and behavioral measures through a combination of non-invasive technologies, including wearables devices, active sensors, cognitive tasks, and/or subjective questionnaires. Participants will perform a stress induction task, after which they will rest in a relaxation room. Physiological measures and cognitive performance will be recorded throughout the experiment to determine whether features of the relaxation room promote recovery after acute stress. Identifying the occurrence of stress and ways to potentially reduce the effects of stress could lead to novel interventions for helping individuals reduce work-related stress.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MindBreaks - Audio-visual
  • Behavioral: MindBreaks - Auditory-only
  • Behavioral: MindBreaks - Visual-only
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recover
Actual Study Start Date :
Dec 2, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Audio-visual Group

Behavioral: MindBreaks - Audio-visual
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain visual and auditory stimuli.

Experimental: Auditory-only Group

This group will recover in the relaxation room with only auditory stimuli.

Behavioral: MindBreaks - Auditory-only
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only auditory stimuli.

Experimental: Visual-only group

Behavioral: MindBreaks - Visual-only
A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only visual stimuli.

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

  1. Change in cognitive performance relative to baseline [throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task]

    Participants will perform the operational SPAN (OSPAN) and symmetry SPAN (SSPAN) working memory assessments at 5 time points throughout the experimental session. The unit score and load score from these assessments are used to measure changes in working memory cognitive performance. Measurements are taken at approximately -35 minutes, -5 minutes, +15 minutes, +35 minutes, and +55 minutes relative to the start of the stress induction task (Trier social stress test, TSST). Each measure will be compared with the -35 minute baseline measurement to detect a change in performance. [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].

  2. Change in perceived stress relative to baseline [throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task]

    Measures of perceived stress from self-reported surveys will be compared before, during and after a stress induction task relative to baseline. Surveys are completed after the cognitive assessments and during the stress induction task. Measurements are taken at approximately -35 minutes, -5 minutes, +5 minutes, +10 minutes, +15 minutes, +35 minutes, and +55 minutes relative to the start of the stress induction task (Trier social stress test, TSST). Each measure will be compared with the -35 minute baseline measurement to detect a change in performance. [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].

  3. Change in heart rate relative to baseline [throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs]

    Measures of heart rate from wearable devices will be compared before, during and after a stress induction task. Heart rate will be measured continuously and binned during the following epochs of the experimental session (all times relative to the start of the stress induction task and are approximates due to some temporal delays in transitioning between epochs): baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes). [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].

  4. Change in electroencephalography (EEG) alpha band power relative to baseline [throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs]

    Measures of neural activity, (electroencephalography, EEG) from a wearable device will be compared before, during and after a stress induction task. Alpha band power will be measured and binned during the following epochs of the experimental session (all times relative to the start of the stress induction task and are approximates due to some temporal delays in transitioning between epochs): baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes). [Note: times are approximate as there might be slight temporal changes due to the self-paced duration it takes each participant to complete certain portions of the experiment].

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Adults at least age 18

  2. Participants are able to remain in the Well Living Lab for 3-4 hours

  3. Participants are able to perform scripted tasks

  4. Participants are able to provide informed consent

  5. Participants are able to wear the wearable devices at all times during the study

  6. Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study

Exclusion Criteria:
  1. Participants with a reported history of diagnosed mood, anxiety, or major health disorders

  2. Participants who have used steroid-based medications within the past three years

  3. Participants with a history of drug/alcohol abuse

  4. Participants with or recovering from nicotine dependency who cannot use a nicotine patch

  5. Participants who consume excessive amounts of caffeine

  6. Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia)

  7. Women who are pregnant or intend to become pregnant at the time of the study

  8. Participants with a history of diagnosed cognitive impairment

  9. Participants taking any medications that might affect the physiological measures of interest

  10. Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Well Living Lab Inc. Rochester Minnesota United States 55902

Sponsors and Collaborators

  • Well Living Lab, Inc.
  • Mayo Clinic
  • Delos Living LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Well Living Lab, Inc.
ClinicalTrials.gov Identifier:
NCT05298189
Other Study ID Numbers:
  • IRB 21-005885
First Posted:
Mar 28, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 28, 2022