What side effects are associated with this type of intervention?

Common treatments for PTSD include mindfulness meditation and pharmacotherapy with SSRIs or SNRIs. Mindfulness meditation is generally well-tolerated with minimal side effects, though some individuals may experience temporary increases in anxiety or emotional discomfort as they become more aware of their thoughts and feelings. SSRIs and SNRIs, while effective, can have side effects such as nausea, insomnia, sexual dysfunction, and increased risk of bleeding. These medications may also cause withdrawal symptoms if discontinued abruptly. Combining mindfulness practices with pharmacotherapy can help manage PTSD symptoms while potentially mitigating some of the side effects associated with medication alone.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), including selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications primarily address the chemical imbalances in the brain associated with PTSD. While the FDA has not specifically approved nature-based or virtual mindfulness interventions for PTSD, these approaches are being studied for their potential to reduce perceived stress and increase psychological resilience. Mindfulness-based stress reduction (MBSR) and other mindfulness techniques have shown promise in clinical trials for improving symptoms of PTSD, but they are generally considered complementary therapies rather than primary FDA-approved treatments.

What other types of research exist?

Promising novel alternatives for PTSD treatment in 2024 include: 1) Psilocybin-assisted psychotherapy, which has shown sustained reductions in psychiatric and existential distress in patients with life-threatening conditions. 2) MDMA-assisted psychotherapy, which has been recognized for its potential in treating PTSD, with expanded access programs approved by the FDA. 3) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can address sleep-related issues often associated with PTSD and improve overall psychological well-being. 4) Mindfulness-Based Cognitive Therapy (MBCT), which has been effective in managing psychological distress and improving quality of life in cancer patients and could be adapted for PTSD.

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Nature-Based + Virtual Mindfulness for Stress in Healthcare Workers

N/A

Waitlist Available

Led By Ann Berger, MD

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 18 years old or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)

Awards & highlights

Study Summary

This trial is investigating 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.

Who is the study for?

This trial is for healthcare workers over 18 who treat COVID-19 patients and can consent to participate. They must be fluent in English, have online access for study materials, and not have acute psychiatric conditions or unaided hearing impairments.Check my eligibility

What is being tested?

The trial tests if nature-based activities combined with virtual mindfulness reduce stress more effectively than just nature activities or no intervention. Ninety participants will be randomly assigned to one of three groups and assessed over approximately 11 weeks.See study design

What are the potential side effects?

Since the interventions involve non-invasive practices like exposure to nature and mindfulness exercises, significant side effects are not anticipated. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), post nature intervention (week 1), post mindfulness intervention (week 3), follow-up (week 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived Stress Scale (PSS)

Secondary outcome measures

General Self-Efficacy Scale (GSF)

Hospital Anxiety and Depression Scale (HADS)

Insomnia Severity Index (ISI)

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Nature+MindfulnessExperimental Treatment1 Intervention

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.

Group II: Nature OnlyActive Control1 Intervention

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.

Group III: ControlActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), help PTSD patients by promoting present-moment awareness and reducing stress reactivity, which can decrease hyperarousal and improve emotional regulation. SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, alleviating mood disturbances and anxiety. These mechanisms are important as they underscore the value of both psychological and pharmacological treatments in managing PTSD symptoms and enhancing quality of life.

Nature videos for PTSD: protocol for a mixed-methods feasibility study.A Pilot Study of Mindfulness-Based Exposure Therapy in OEF/OIF Combat Veterans with PTSD: Altered Medial Frontal Cortex and Amygdala Responses in Social-Emotional Processing.The Effectiveness of Mindfulness Training in Improving the Quality of Life of the War Victims with Post Traumatic stress disorder (PTSD).