CD2H COVID-19

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

Purpose

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.

Conditions

Stress, Psychological
Sleep Disturbance
Burnout, Caregiver
Posttraumatic Stress Disorder
Anxiety
Depression

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Arm Groups

Arm	Description	Assigned Intervention
No Intervention Control	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.
Active Comparator Nature Only	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 See above for description.
Experimental Nature+Mindfulness	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.

Recruiting Locations

More Details

NCT ID: NCT04846790
Status: Enrolling by invitation
Sponsor: National Institutes of Health Clinical Center (CC)

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.