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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Mental Health, Cognition, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Biophilic experience | Experimental | Healthcare 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted7 Feb 2022
- Study start27 Sep 2022
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- Mar Cortes, MD, Principal investigator, Icahn School of Medicine
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Concepts of Bio-experiential Spaces
- ClinicalTrials.gov ID
- NCT05227352
- Acronym / sponsor ID
- STUDY-21-01221
- Conditions
- Mental Health, Cognition, Anxiety
- Keywords
- biophilic design, mental health, cognition, PTSD, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 7 Feb 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biophilic experience | Experimental | Behavioral: Biophilic design experienceHealthcare workers will experience the biophilic-designed room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over the age of 18
- Current healthcare employee of Mount Sinai Hospital or the Icahn School of Medicine at Mount Sinai
Key exclusion criteria (2 listed)
- Age under 18
- Not employed by Mount Sinai or Icahn School of Medicine at Mount Sinai
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 |
|---|---|---|
| Biophilic design experienceRecharge Rooms are immersive, biophilic private spaces featuring multisensory input that is inspired by nature. | Behavioural | Biophilic experience |
Primary outcome
Well-Being Index
Time frame: 6 weeks
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.
16 secondary outcomes
Generalized Anxiety Disorder 7 (GAD7)
Time frame: 6 weeks
The Patient Health Questionnaire (PHQ-9)
Time frame: 6 weeks
The Insomnia Severity Index (ISI)
Time frame: 6 weeks
The Fatigue Severity Scale (FSS)
Time frame: 6 weeks
Brief Resilience Scale (BRS)
Time frame: 6 weeks
Satisfaction With Life Scale (SWLS)
Time frame: 6 weeks
Maslach Burnout Inventory-Human Services Survey
Time frame: 6 weeks
Social Connectedness Scale
Time frame: 6 weeks
Situational Awe Scale
Time frame: 6 weeks
Heart Rate Pulse Oximeter
Time frame: 6 weeks
Oxygen Saturation (pO2) Oximeter
Time frame: 6 weeks
Automatic Blood Pressure
Time frame: 6 weeks
Galvanic Skin Response (GSR)
Time frame: 6 weeks
Power spectrum density by EEG
Time frame: 6 weeks
Coherence by EEG
Time frame: 6 weeks
Frequency band power by EEG
Time frame: 6 weeks
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 7 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
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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.
Mar Cortes, MD principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
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.