What side effects are associated with this type of intervention?

Common treatments for mental health that are similar to the Recharge Rooms, such as meditation, mindfulness-based interventions, relaxation therapy, and guided imagery, generally have minimal side effects. However, some individuals may experience temporary discomfort, such as increased anxiety or panic during relaxation (known as relaxation-induced panic), or emotional distress as they become more aware of their thoughts and feelings. Overall, these therapies are considered safe and the potential benefits often outweigh the risks.

What prior FDA approvals exist?

The FDA has approved various treatments for mental health, particularly for reducing stress and anxiety. These include pharmacological options like SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), which are commonly used to treat anxiety disorders and depression. Additionally, non-pharmacological treatments such as Cognitive Behavioral Therapy (CBT) have been widely recognized for their efficacy. While the FDA has not specifically approved multisensory, biophilic environments like Recharge Rooms, these innovative approaches are being studied for their potential benefits in reducing stress and anxiety among healthcare workers.

What other types of research exist?

Promising alternatives to Recharge Rooms for mental health patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in treating depression and anxiety; 2) Vagus Nerve Stimulation (VNS), used for treatment-resistant depression; 3) Psilocybin-assisted psychotherapy, which has demonstrated long-term benefits for treatment-resistant depression and existential distress; 4) Biofeedback and neurofeedback, which help patients manage stress and anxiety through real-time monitoring and feedback of physiological functions; 5) Guided imagery and progressive muscle relaxation, which have been effective in reducing pain and anxiety in cancer patients.

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Behavioral Intervention

Biophilic Design for Mental Health in Healthcare Workers

N/A

Recruiting

Led By Mar Cortes, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial is designed to study the effects of immersive, biophilic private spaces on healthcare workers' trauma, anxiety, and stress.

Who is the study for?

This trial is for healthcare workers over the age of 18 at Mount Sinai Hospital or Icahn School of Medicine. It's designed to help those experiencing trauma, anxiety, or stress related to their job.Check my eligibility

What is being tested?

The study tests 'Recharge Rooms' with biophilic design—spaces that use nature-inspired elements like plant imitations, natural landscape projections, tailored lighting, nature sounds with music, and calming scents—to improve mental health.See study design

What are the potential side effects?

Since this intervention involves sensory experiences in a controlled environment without medications or invasive procedures, no significant side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Well-Being Index

Secondary outcome measures

Automatic Blood Pressure

Brief Resilience Scale (BRS)

Coherence by EEG

+13 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Biophilic experienceExperimental Treatment1 Intervention

Healthcare workers will experience the biophilic-designed room

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mental health that are similar to the Recharge Rooms include mindfulness-based practices, meditation, and relaxation therapies. These treatments work by engaging the parasympathetic nervous system, which helps to reduce stress and anxiety. They often involve focusing attention on calming stimuli, such as nature sounds, soothing visuals, and pleasant scents, which can lower cortisol levels and promote a sense of well-being. For mental health patients, these treatments are crucial as they provide non-pharmacological options to manage symptoms, improve emotional regulation, and enhance overall mental health without the side effects associated with medication.

[Treatment terminations and transfers of schizophrenic patients in inpatient treatment with psychotherapeutic emphasis. A systematic study].Solution Focused Brief Therapy Telemental Health Suicide Intervention.Psychotherapy for Borderline Personality Disorder: Progress and Remaining Challenges.

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

871 Previous Clinical Trials

527,191 Total Patients Enrolled

Mar Cortes, MDPrincipal InvestigatorIcahn School of Medicine

Media Library

Bio-Experiential Spaces (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05227352 — N/A

Mental Health Research Study Groups: Biophilic experience

Mental Health Clinical Trial 2023: Bio-Experiential Spaces Highlights & Side Effects. Trial Name: NCT05227352 — N/A

Bio-Experiential Spaces (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227352 — N/A

~5 spots leftby Sep 2024

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