A Study of Positive Emotions With Long COVID (Post-Acute Sequelae of SARS CoV-2 Infection)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Well-being
Study Overview
Brief Summary
This study is testing a new brief mindfulness practice for people suffering from long COVID-19 symptoms. People suffering from long COVID are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. The goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long COVID.
Detailed Description
This is a pilot randomized waitlist-controlled clinical trial (RCT) testing a new brief self-care intervention for people suffering from post-acute sequelae SARS-CoV-2 infection (PASC). The overarching goal of this study is to establish the feasibility and early efficacy of microdosing mindfulness as a self-care intervention. The purpose of the intervention is to promote a sense of well-being among PASC patients who currently have limited access to other proven self-care modalities.
Our research question is whether our newly developed training can assist PASC patients to self-microdose mindfulness (5-15 seconds activities in everyday life) and improve on perceived metrics of well-being (primary outcome). Our hypothesis is that self-microdosing mindfulness will evoke positive emotions that can improve well-being on patients suffering of PASC-related symptoms beyond 3 months post COVID-19 infection. If effective, an increased frequency of the mindfulness activity will then help buffer negative emotions (e.g., anger, loneliness, etc.) experienced during the pandemic and associated with ongoing stress and/or somatic symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to participate in online zoom sessions and complete online surveys for 3 months
- •English speakers
- •Had a mild to moderate in severity COVID-19 infection > 3 months ago, feeling unwell, and are still experiencing in the present at least one PASC-related symptoms:
- •Coughing or feeling short of breath
- •Loss of smell or change in taste
- •Recurrent Fever
- •Body aches, headaches, chest pain, or stomach pain
- •Brain fog (feeling like you can't think clearly)
- •Having trouble sleeping
- •Feeling very tired
- •Mood changes
Exclusion Criteria
- •Adults that were admitted to an intensive care unit or placed on a respirator, had invasive heart (heart catheterization) or lung tests (bronchoscopy) performed.
- •Prisoners
Arms & Interventions
Waitlist control
Treatment
Intervention: Microdosing of mindfulness (Behavioral)
Outcomes
Primary Outcomes
Well-being
Time Frame: 1 month
14 items from the Mental Health Continuum Short Form
Secondary Outcomes
- Perceived Stress(1, 3 and 12 months)
- Physical health(1, 3 and 12 months)
- Anxiety symptoms(1, 3 and 12 months)
- Depressive symptoms(1, 3 and 12 months)
- Well-being(3 and 12 months)
- Cardiac symptoms(1, 3 and 12 months)