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Nature-Based + Virtual Mindfulness for Stress in Healthcare Workers

N/A
Waitlist Available
Led By Ann Berger, MD
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is 18 years old or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)
Awards & highlights

Study Summary

This trial is investigating the feasibility and efficacy of a combined nature-based and virtual mindfulness intervention on stress-related symptoms and psychological resilience in healthcare workers that care for patients with COVID-19.

Who is the study for?
This trial is for healthcare workers over 18 who treat COVID-19 patients and can consent to participate. They must be fluent in English, have online access for study materials, and not have acute psychiatric conditions or unaided hearing impairments.Check my eligibility
What is being tested?
The trial tests if nature-based activities combined with virtual mindfulness reduce stress more effectively than just nature activities or no intervention. Ninety participants will be randomly assigned to one of three groups and assessed over approximately 11 weeks.See study design
What are the potential side effects?
Since the interventions involve non-invasive practices like exposure to nature and mindfulness exercises, significant side effects are not anticipated. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perceived Stress Scale (PSS)
Secondary outcome measures
General Self-Efficacy Scale (GSF)
Hospital Anxiety and Depression Scale (HADS)
Insomnia Severity Index (ISI)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nature+MindfulnessExperimental Treatment1 Intervention
In the combined nature-based and virtual mindfulness intervention, participants will complete the nature intervention followed by the mindfulness intervention. The virtual mindfulness intervention is 10 days long and offered online. Each day the participant will receive a notification that a new mindfulness audio is ready for viewing, which is from 10 to 25 minutes long. Mindfulness exercises include mindful breathing, body scan, and loving-kindness meditation. Participants can view the daily audio as many times as they wish but cannot view the next day's content to maintain treatment fidelity. At the end of each day, participants will be asked to indicate if they viewed the mindfulness audio to track adherence.
Group II: Nature OnlyActive Control1 Intervention
The nature-based intervention is three days long, is offered at various locations throughout the United States, and includes activities such as hiking, mountain-biking, and kayaking. The healthcare workers can participate in the programs that are offered locally pending availability. Each program will enroll between 15 and 30 healthcare workers. All First Descents nature-based interventions have been intentionally designed with input from more than 450 hospital partners nationwide to improve psychosocial health, nurture supportive peer relationships, and better position healthcare workers to carry out their critical mission. There is no cost to attend, and meals and lodging are included. Special precautions against SARS-CoV-2 transmission are implemented.
Group III: ControlActive Control1 Intervention
The control group will complete the first three assessments similar to the two treatment groups but will not participate in the nature-based or virtual mindfulness interventions. At the end of their study participation (~week 3), they will be offered the opportunity to partake in the nature-based and virtual mindfulness interventions.

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
881,108 Total Patients Enrolled
Ann Berger, MDPrincipal InvestigatorNational Institutes of Health (NIH)

Media Library

Nature+Mindfulness Clinical Trial Eligibility Overview. Trial Name: NCT04846790 — N/A
Post-Traumatic Stress Disorder Clinical Trial 2023: Nature+Mindfulness Highlights & Side Effects. Trial Name: NCT04846790 — N/A
Nature+Mindfulness 2023 Treatment Timeline for Medical Study. Trial Name: NCT04846790 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Nature+Mindfulness, Nature Only, Control
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04846790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical trial?

"Clinicaltrials.gov reveals that this research is no longer recruiting patients, despite being first posted in July 2021 and last updated on September 2022. Nevertheless, there are 1948 other trials currently searching for participants to join their studies."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Other
Virginia
Maryland
How old are they?
65+
18 - 65
What site did they apply to?
National Institutes of Health, Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Chronic insomnia - I have tried almost every cure.
PatientReceived no prior treatments
Recent research and studies
~16 spots leftby Dec 2024