An interventional study of Nature Only and Nature+Mindfulness in Stress, Psychological, Sleep Disturbance and Burnout, Caregiver, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Supportive care
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.
Potential participants will be recruited through First Descents, a non-profit 501(c)(3) organization located in the United States.
The nature-based intervention is three days long and includes activities such as hiking, mountain-biking, and kayaking. The virtual mindfulness intervention is 10 to 25 minutes daily for 10 days and is offered online. Mindfulness exercises include mindful breathing, body scan, and loving-kindness meditation.
2,237 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.
This study's enrollment of 54 is below the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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Inclusion: In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion: An individual who meets any of the following criteria will be excluded from participation in this study:
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.
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.
Behavioral: Nature Only
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.
Behavioral: Nature+Mindfulness
See above for description.
See above for description.
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is used to assess self-reported sleep quality. It is a 7-item index, with a total range from 0 (no symptoms) to 28 (highest severity).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Maslach Burnout Inventory (MBI 2-Item)
The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion and depersonalization separately from 1 (no symptoms) to 7 (highest severity).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is used to assess self-reported posttraumatic stress symptoms. It is a 20-item checklist, with a total range from 20 (no symptoms) to 100 (highest severity).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is used to assess self-reported anxiety and depression. It consists of two 7-item scales (for anxiety and for depression), with a sub-scale range from 0 (no symptoms) to 21 (highest severity).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Mindful Attention Awareness Scale-State Version (MAAS-S)
The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
General Self-Efficacy Scale (GSF)
The General Self-Efficacy Scale (GSF) is used to assess self-reported coping ability in daily life. It is a 10-item scale, with a total range from 10 (low self-efficacy) to 40 (high self-efficacy).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS)
The National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS) is used to assess self-reported psycho-social-spiritual mechanisms for coping. It is a 35-item questionnaire, with a total range from 35 (low coping) to 175 (high coping).
Time frame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Plan to share: No
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Stress Disorders, Post-Traumatic→
National Institutes of Health Clinical Center (CC)