A Study of Positive Emotions With Long COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Positive Emotions With Long COVID (Post-Acute Sequelae of SARS CoV-2 Infection)

Conditions
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Post-Acute COVID-19 Syndrome

Intervention / Treatment
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* Behavioral: Microdosing of mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist control<br> | |
| Experimental: Treatment<br> | Behavioral: Microdosing of mindfulness<br>* The intervention consists of two parts: 1) four structured training sessions offered as online synchronous classes, and 2) self-microdosing of mindfulness activities in everyday life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | 14 items from the Mental Health Continuum Short Form | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress | Perceived Stress Scale | 1, 3 and 12 months | 
| Anxiety symptoms | Generalized Anxiety Disorder scale | 1, 3 and 12 months | 
| Depressive symptoms | Beck Depression Inventory Short Form | 1, 3 and 12 months | 
| Physical health | Physical health symptoms - 11 items + 3 items of COVID symptoms | 1, 3 and 12 months | 
| Cardiac symptoms | Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12) | 1, 3 and 12 months | 
| Well-being | 14 items from the Mental Health Continuum Short Form | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness