Nature+Mindfulness for Stress, Psychological

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health, Clinical Center, Bethesda, MD
Stress, Psychological+10 More
Nature+Mindfulness - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combined nature-based and virtual mindfulness intervention can reduce stress-related symptoms and increase psychological resilience in healthcare workers that care for patients with COVID-19.

See full description

Eligible Conditions

  • Stress, Psychological
  • Post Traumatic Stress Disorder (PTSD)
  • Caregivers Burnout
  • Anxiety
  • Sleep Disturbance
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Nature+Mindfulness will improve 1 primary outcome and 7 secondary outcomes in patients with Stress, Psychological. Measurement will happen over the course of Baseline (week 0), Post Nature Intervention (week 1), Post Mindfulness Intervention (week 3), Follow-up (week 11).

Week 11
General Self-Efficacy Scale (GSF)
Hospital Anxiety and Depression Scale (HADS)
Insomnia Severity Index (ISI)
Maslach Burnout Inventory (MBI 2-Item)
Mindful Attention Awareness Scale-State Version (MAAS-S)
National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS)
Perceived Stress Scale (PSS)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Nature Only
1 of 3
Control
1 of 3
Nature+Mindfulness
1 of 3
Active Control
Experimental Treatment

This trial requires 90 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nature+Mindfulness is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Nature+Mindfulness
Behavioral
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.
Nature Only
Behavioral
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.
ControlThe 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11) for reporting.

Who is running the study

Principal Investigator
A. B. M.
Ann Berger M.D., Chief of the Pain and Palliative Care Service
National Institutes of Health Clinical Center (CC)

Closest Location

National Institutes of Health, Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
a healthcare worker that is at risk of getting the virus? A healthcare worker that is caring for patients with COVID-19 is not necessarily at risk of getting the virus show original
The text implies that the person has access to technology that will allow them to access resources online. show original
Someone who has a hearing impairment that cannot be corrected with the use of hearing aids or other devices. show original
The text is saying that someone who is 18 years old or older is considered to be an adult. show original
Is able to provide their own consent
Is experiencing an acute psychiatric condition
I can speak English fluently. show original

Patient Q&A Section

What is dyssomnias?

"The term 'parasomnias' describes a heterogeneous group of sleep, arousal, waking and sleeping disturbances that occur and appear to affect the life of people of all ages, including infants. The concept of 'parasomnias' is not synonymous with, but rather an attempt to replace descriptive, descriptive and diagnostic'sleep disorders' in psychiatry, and thus it may be misleading. Given current and evolving knowledge regarding the cause and mechanisms of parasomnias as well as the heterogeneity of the group, and the lack of consensus regarding their definitions, diagnosis and classification, 'parasomnias' is a useful term which, if properly used and applied, should be of benefit to clinicians." - Anonymous Online Contributor

Unverified Answer

What are the signs of dyssomnias?

"This is one of a handful of studies reporting on the clinical presentation and treatment of dyssomnias. The findings are consistent with the current literature in that it demonstrates that dyssomnias are commonly unrecognised in general clinical practice but can be treated with reasonable fidelity." - Anonymous Online Contributor

Unverified Answer

What are common treatments for dyssomnias?

"Dyssomnia is an uncommon disease, with over 100 medical diseases being associated with sleep disturbance. This article presents treatment options when dyssomnia is secondary to other medical conditions (such as heart failure, depression, psychiatric disorders, and ankylosing spondylitis). Patients with sleep bruxism in particular can benefit from prescription or non-prescription sedative hypnotics and anticonvulsants." - Anonymous Online Contributor

Unverified Answer

Can dyssomnias be cured?

"Although this study had a small sample size, with only four subjects it was difficult to draw definitive conclusions. Results from a recent clinical trial are encouraging, however. Dyssomnias can be treated." - Anonymous Online Contributor

Unverified Answer

How many people get dyssomnias a year in the United States?

"This is the first study to report on the number of the comorbidities that make up the DIMS, and to document the prevalence of each DIMS. The DIMS have been shown to be highly prevalent. In addition, the results of this study point to the need to establish the nature of this comorbidity and its relation to major depression and dyssomnias in future research." - Anonymous Online Contributor

Unverified Answer

What causes dyssomnias?

"The etiology of dyssomnias is multifactorial and involves a complex interaction between the environmental, psychological, and the autonomic nervous systems, in which genetic predispositions may contribute." - Anonymous Online Contributor

Unverified Answer

Is nature+mindfulness typically used in combination with any other treatments?

"These preliminary findings add further evidence that mindfulness-based intervention may produce positive effects on mood and self-esteem. While there was no difference in duration of distress in the 2 experimental group conditions, this small randomized controlled study demonstrated that a mindfulness-based approach adds significant benefit over the standard antidepressant method when used in combination." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nature+mindfulness for therapeutic use?

"In this review, we discuss new evidence supporting the potential therapeutic efficacy for (1) non-invasive nature+mindfulness intervention for anxiety disorders, (2) non-invasive nature+mindfulness intervention for depression, and (3) non-invasive nature+mindfulness intervention for irritable bowel syndrome (IBS). The review also highlights potential challenges with non-invasive nature+mindfulness interventions." - Anonymous Online Contributor

Unverified Answer

How serious can dyssomnias be?

"All types of excessive sleepiness are associated with increased death from accidents and other causes. The risk of dying from accidents and other causes were almost double the risk of dying of an accident and another cause when sufferers were sleepy, even if they slept only 3.0+ hours a day. The risk of dying from an accident and other causes were increased by almost 1.5 fold when sufferers slept only 1.8 hours a day, and almost doubled when sufferers slept 2.0+ hours a day." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of dyssomnias?

"This review has identified five common causes of DSD that can be detected in the differential diagnosis of DSD. However, these diagnoses are relatively recent and are not often reported in the medical literature so clinicians must be aware of them to ensure correct diagnosis. Recognizing these causes and having a plan on how best to treat DSD based on the cause are critical factors in determining the outcome after identification." - Anonymous Online Contributor

Unverified Answer

What does nature+mindfulness usually treat?

"Self-care, environmental changes (such as sleeping more and staying in nature), and mindfulness-based cognitive training have not been adequately studied in DME. For these interventions, a randomized clinical trial with long-term follow-up is needed as a next step in future research." - Anonymous Online Contributor

Unverified Answer

What is the latest research for dyssomnias?

"Data from a recent study of clinical trials in patients with dyssomnia have been rather disappointing, but promising results in animal studies have been reported. The development of drug or nonpharmacologic therapies might be worthwhile." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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