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

Depression Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04846790
• Other study ID #: CC-000192
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Burnout, Caregiver
• Caregiver Burden
• Depression
• Dyssomnias
• Parasomnias
• Posttraumatic Stress Disorder
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress, Psychological

Intervention

Behavioral:
• Nature Only
See above for description.
• Nature+Mindfulness
See above for description.

Locations

Country	Name	City	State
United States	National Institutes of Health, Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)
Secondary	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).	Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11)