Post-Acute COVID-19 Syndrome
Conditions
Keywords
Mindfulness
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.
Interventions
BEHAVIORALMicrodosing of mindfulness
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.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Well-being | 1 month | 14 items from the Mental Health Continuum Short Form |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | 1, 3 and 12 months | Perceived Stress Scale |
| Anxiety symptoms | 1, 3 and 12 months | Generalized Anxiety Disorder scale |
| Depressive symptoms | 1, 3 and 12 months | Beck Depression Inventory Short Form |
| Physical health | 1, 3 and 12 months | Physical health symptoms - 11 items + 3 items of COVID symptoms |
| Cardiac symptoms | 1, 3 and 12 months | Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12) |
| Well-being | 3 and 12 months | 14 items from the Mental Health Continuum Short Form |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJavier E Lopez, MD
University of California, Davis
Outcome results
None listed