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Mental HealthNCT05227352

Bio-Experiential Spaces for Mental Health in Healthworkers

A study testing Biophilic design experience in people with Mental Health and Cognition, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recharge Rooms are immersive, biophilic private spaces designed to ameliorate trauma, anxiety, and stress. They feature multisensory input that is inspired by nature, as has previously been found to confer physiological benefits. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health, Cognition, Anxiety
What is being tested?
Biophilic design experience
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
27 Sep 2022to 8 Jan 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults over the age of 18
  • Current healthcare employee of Mount Sinai Hospital or the Icahn School of Medicine at Mount Sinai

Who cannot join

  • Age under 18
  • Not employed by Mount Sinai or Icahn School of Medicine at Mount Sinai

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Recharge Room at Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

About this study

Official title: Exploring the Concepts of Bio-experiential Spaces

Recharge Rooms are immersive, biophilic private spaces designed to ameliorate trauma, anxiety, and stress. They feature multisensory input that is inspired by nature, as has previously been found to confer physiological benefits. These environments include silk imitation plants, projected scenes of soothing natural landscapes, low lighting that is tailored in color to match the landscapes that are being projected, high definition audio recordings of nature sounds paired with relaxing music, and infusion of essential oils and calming scents.

The aim is to investigate the physiological and mental health outcomes that the short and long term exposure to these rooms have on healthcare workers. The data will be collected through online surveys. No identifiable information will be assessed or collected. The plan is to have 60 participants.

Being tested
Biophilic design experience
Keywords
biophilic design, mental health, cognition, PTSD, anxiety, stress
Medical subject headings
Psychological Well-Being, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biophilic design experienceBehavioural

    Recharge Rooms are immersive, biophilic private spaces featuring multisensory input that is inspired by nature.

Study groups in NCT05227352
Study groupRoleWhat they receive
Biophilic experienceExperimentalHealthcare workers will experience the biophilic-designed room
Receives: Behavioral: Biophilic design experience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Well-Being Index

    This assesses a variety of dimensions such as burnout, fatigue, mental and physical quality of life (QOL), depression and anxiety, and is used as a screening tool to assess residents at "high risk," who may be in distress, and who benefit from added resources and subsequent help seeking. It uses yes/no response categories, and a total score is calculated by adding the number of 'yes' responses. Full scale range from 0 to 7, with higher score indicating poorer health outcome, and a threshold score of 5 is used to identify "high risk" residents.

    Measured: 6 weeks

Secondary outcomes (16)
  1. Generalized Anxiety Disorder 7 (GAD7)

    This 7-item instrument uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. It can also be used as a screening measure of panic, social anxiety, and PTSD. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0-3. Items are summed to provide a total score. Full scale from 0-21, with higher score indicating more symptoms.

    Measured: 6 weeks

  2. The Patient Health Questionnaire (PHQ-9)

    This is the major depressive disorder (MDD) module of the full PHQ. It is one of the most validated tools in mental health and can be a powerful tool to assist clinicians with diagnosing depression and monitoring treatment response. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively . Full scale from 0-27, with higher score indicating more severe symptoms.

    Measured: 6 weeks

  3. The Insomnia Severity Index (ISI)

    This is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. There are seven questions and the total score is found by summing the answers to the seven questions. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). The total score ranges from 0-28 where higher score indicates increased severity of insomnia.

    Measured: 6 weeks

  4. The Fatigue Severity Scale (FSS)

    This is a 9-item scale which measures severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. Full scale from 9 - 63, with higher score indicating greater fatigue severity.

    Measured: 6 weeks

  5. Brief Resilience Scale (BRS)

    This is a self-rating questionnaire aimed at measuring an individuals' ability to "bounce back from stress". The possible full scale range on the BRS is from 1 (low resilience) to 5 (high resilience), with higher score indicating higher resilience. The scores can be interpreted as follows: 1.00-2.99= low resilience; 3.00-4.30= normal resilience; 4.31-5.00= high resilience.

    Measured: 6 weeks

  6. Satisfaction With Life Scale (SWLS)

    SWLS is designed to measure global cognitive judgments of satisfaction with one's life. The scale usually requires only about one minute of a respondent's time. Life satisfaction is one factor in the more general construct of subjective well-being. The SWLS is a 7-point Likert style response scale. The full scale range is from 5-35, with a higher score indicating higher levels of life satisfaction. A score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.

    Measured: 6 weeks

  7. Maslach Burnout Inventory-Human Services Survey

    This measures the degree of burnout. Within the survey 3 domains are evaluated: Emotional Exhaustion (EE), 9 questions; Depersonalization (DP), 5 questions; and Personal Accomplishment (PA), 8 questions. All MBI-HSS items are scored on a Likert scale ranging from "never"=0 to "daily"=6. Scores from within each domain are added up and participants are classified into tiers (High, Moderate or Low) per domain. A high score of EE (score of 27 or higher) or a high score of DP (total score of 10 or higher) is considered indicative of clinically significant burnout in medical trainees.

    Measured: 6 weeks

  8. Social Connectedness Scale

    This assesses the degree to which you feel connected to others in social environments.The is a 20-item questionnaire that scales responses from 1 (strongly disagree to 6 (strongly agree). The items are summed with full range scale from 20 - 120; a higher score indicates more connectedness to others.

    Measured: 6 weeks

  9. Situational Awe Scale

    This is a self-reported measure to assess the momentary phenomenological experience of awe. 30-item instrument, each item scored on a 7-point scale: -3 (disagree strongly) to +3 (agree strongly). Full scale from 30 - 210, higher score indicates a stronger experience of awe.

    Measured: 6 weeks

  10. Heart Rate Pulse Oximeter

    This will be used to noninvasively measure heart rate (HR). Pulse oximetry is used to measure the oxygen level of the blood by using infrared light. The device will be placed on the participant's finger. The normal range for resting heart rate is between 60-100 beats per minute.

    Measured: 6 weeks

  11. Oxygen Saturation (pO2) Oximeter

    This will be used to noninvasively measure oxygen saturation (pO2). Pulse oximetry is used to measure the oxygen level of the blood by using infrared light. The device will be placed on the participant's finger. The normal range for oxygen saturation is 89-100%.

    Measured: 6 weeks

  12. Automatic Blood Pressure

    This will be used to measure blood pressure. The normal level for systolic blood pressure is less than 120 mmHg. The normal level for diastolic blood pressure is less than 80 mmHg.

    Measured: 6 weeks

  13. Galvanic Skin Response (GSR)

    This is one of the most sensitive measures for emotional arousal. Galvanic Skin Response originates from the autonomic activation of sweat glands in the skin. The sweating on hands and feet is triggered by emotional stimulation: Whenever a person is emotionally aroused, the GSR data shows distinctive patterns that are visible with bare eyes and that can be quantified statistically. A GSR device containing two electrodes will be placed on the skin of the participant during the Recharge Room experience. GSR is measured in the unit of microSiemens. Measurements normal range: 0-15 microSiemens.

    Measured: 6 weeks

  14. Power spectrum density by EEG

    Quantitative electroencephalography (EEG) power spectrum density. Mean power is the percentage of change between PRE and POST of the average power along time in each frequency band and electrode.

    Measured: 6 weeks

  15. Coherence by EEG

    Quantitative electroencephalography (EEG) coherence. Mean coherence is the percentage of change between PRE and POST of the mean coherence in each band and each electrode, defined as the average coherence of this electrode with all the other ones.

    Measured: 6 weeks

  16. Frequency band power by EEG

    Quantitative electroencephalography (EEG) frequency band power. Mean frequency is the percentage of change between PRE and POST of the mean frequency in each band and electrode, defined as the mean frequency of the power spectrum weighted over that band.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start27 Sep 2022
  3. Primary completion8 Jan 2025
  4. Study completion8 Jan 2025

Resources

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 N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227352
Sponsor's protocol ID
STUDY-21-01221
Status last verified
Sep 2024
First submitted
26 Jan 2022
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share IPD at this time.

Questions about this trial

What is this clinical trial studying?

A study testing Biophilic design experience in people with Mental Health and Cognition, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 2 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 7 Mar 2025. 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.

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?

Well-Being Index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Mar 2025.

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