Clinical trial NCT04846790: The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare Workers
Official title: The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare Workers That Care for Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Sleep Disturbance
Burnout, Caregiver
Posttraumatic Stress Disorder
Anxiety
Depression
Keywords: Resilience
Mindfulness
Meditation
Nature
Interventions
COVID-19
Pandemic
Healthcare workers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2021-04-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase III, randomized controlled trial, whereby ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Is 18 years old or older
2. Is a healthcare worker that cares for patients with COVID-19
3. Has access to technology to access study resources online
4. Is fluent in English
5. Is able to provide their own consent

Exclusion: An individual who meets any of the following criteria will be excluded from participation in this study:

1. Is experiencing an acute psychiatric condition
2. Has a hearing impairment that is not modified with aids or devices

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: Maslach Burnout Inventory (MBI 2-Item)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: Mindful Attention Awareness Scale-State Version (MAAS-S)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: General Self-Efficacy Scale (GSF)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
measure: National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS)
timeFrame: Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health, Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health (NIH)
name: Ann Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ameli R, Sinaii N, West CP, Luna MJ, Panahi S, Zoosman M, Rusch HL, Berger A. Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2013424. doi: 10.1001/jamanetworkopen.2020.13424.
citation: Rusch HL, Rosario M, Levison LM, Olivera A, Livingston WS, Wu T, Gill JM. The effect of mindfulness meditation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. Ann N Y Acad Sci. 2019 Jun;1445(1):5-16. doi: 10.1111/nyas.13996. Epub 2018 Dec 21.
citation: Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018.
citation: Ameli R, Skeath P, Abraham PA, Panahi S, Kazman JB, Foote F, Deuster PA, Ahmad N, Berger A. A nature-based health intervention at a military healthcare center: a randomized, controlled, cross-over study. PeerJ. 2021 Jan 4;9:e10519. doi: 10.7717/peerj.10519. eCollection 2021.