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

Primary Purpose

Stress, Psychological, Sleep Disturbance, Burnout, Caregiver

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nature Only
Nature+Mindfulness
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring Resilience, Mindfulness, Meditation, Nature, Interventions, COVID-19, Pandemic, Healthcare workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Institutes of Health, Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Nature Only

Nature+Mindfulness

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
April 14, 2021
Last Updated
March 22, 2023
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT04846790
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Sleep Disturbance, Burnout, Caregiver, Posttraumatic Stress Disorder, Anxiety, Depression
Keywords
Resilience, Mindfulness, Meditation, Nature, Interventions, COVID-19, Pandemic, Healthcare workers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All study team members and participants will be blind to group allocation with the exception of one research assistant who will not be involved in providing the intervention to the participants or data analysis. There is no outcome assessor, outcomes will be self-reported.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nature Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nature+Mindfulness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nature Only
Intervention Description
See above for description.
Intervention Type
Behavioral
Intervention Name(s)
Nature+Mindfulness
Intervention Description
See above for description.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
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)
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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)
Title
Maslach Burnout Inventory (MBI 2-Item)
Description
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)
Title
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Description
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)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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)
Title
Mindful Attention Awareness Scale-State Version (MAAS-S)
Description
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)
Title
General Self-Efficacy Scale (GSF)
Description
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)
Title
National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Is 18 years old or older Is a healthcare worker that cares for patients with COVID-19 Has access to technology to access study resources online Is fluent in English 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: Is experiencing an acute psychiatric condition Has a hearing impairment that is not modified with aids or devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Berger, MD
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health, Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32840621
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.
Results Reference
background
PubMed Identifier
30575050
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.
Results Reference
background
PubMed Identifier
30540764
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.
Results Reference
background
PubMed Identifier
33505785
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.
Results Reference
background

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

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