NCT04846790

The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare Workers

Completed NA Last updated 30 May 2025

What this trial tests

NA trial testing Nature Only in Stress, Psychological in 54 participants. Completed in 2 January 2024.

Timeline

16 July 2021

Primary endpoint
25 October 2023

2 January 2024

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	54
Start date	16 July 2021
Primary completion	25 October 2023
Estimated completion	2 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Nature Only
• Nature+Mindfulness

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Sleep Disturbance — all drugs for Sleep Disturbance →
• Burnout, Caregiver — all drugs for Burnout, Caregiver →
• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with Stress, Psychological or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social distancing can limit the accessibility of mental health services. Feasible and effective interventions are needed to reduce stress-related symptoms and promote resilience in this population, while adhering to federal and local guidelines to mitigate the transmission of SARS-CoV-2.

Objectives: To investigate 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. Both components are reported to reduce levels of perceived stress and increase psychological resilience; however, the potential additive effect of their combined delivery is unknown.

Methods: Ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30). All participants will undergo assessments at baseline (week 0), post nature intervention (\~week 1), and post mindfulness intervention (\~week 3). The two intervention groups will have one final assessment at 2-month follow-up (\~week 11). Perceived stress is the primary endpoint and will be assessed with the Perceived Stress Scale. Secondary endpoints include sleep quality, burnout, posttraumatic stress, anxiety, depression, mindfulness, self-efficacy, and psycho-social-spiritual healing.

Anticipated Results: We anticipate that participants in the Nature+Mindfulness group will have greater reductions in stress-related symptoms and greater increases in psychological resilience compared with the Nature only and Control groups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of the National Institute of Health Healing Experience of All Life Stressors Short Form (NIH-HEALS-SF).
   Vocci MC, Bagereka P, Ameli R, Sinaii N, et al · · 2025 · PMID 41661918 · DOI 10.1371/journal.pmen.0000276
2. Effects of a combined nature-based and audio-based virtual mindfulness intervention on stress and wellbeing of COVID-19 healthcare workers: a randomized controlled trial.
   Bagereka P, Ameli R, Sinaii N, Vocci MC, et al · · 2025 · PMID 40421373 · DOI 10.7717/peerj.19109