Anxiety, Burnout, Caregiver, Depression, Posttraumatic Stress Disorder, Sleep Disturbance, Stress, Psychological
Conditions
Keywords
Resilience, Mindfulness, Meditation, Nature, Interventions, COVID-19, Pandemic, Healthcare workers
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.
Interventions
BEHAVIORALNature Only
See above for description.
BEHAVIORALNature+Mindfulness
See above for description.
Sponsors
National Institutes of Health Clinical Center (CC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, 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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maslach Burnout Inventory (MBI 2-Item) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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). |
| Insomnia Severity Index (ISI) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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). |
| General Self-Efficacy Scale (GSF) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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). |
| Mindful Attention Awareness Scale-State Version (MAAS-S) | Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11) | 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). |
Countries
United States
Outcome results
None listed