Clinical trial NCT05676008: A Study of Positive Emotions With Long COVID-19
Official title: A Study of Positive Emotions With Long COVID (Post-Acute Sequelae of SARS CoV-2 Infection)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Keywords: Mindfulness
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Well-being
timeFrame: 1 month
Secondary outcomes:
measure: Perceived Stress
timeFrame: 1, 3 and 12 months
measure: Anxiety symptoms
timeFrame: 1, 3 and 12 months
measure: Depressive symptoms
timeFrame: 1, 3 and 12 months
measure: Physical health
timeFrame: 1, 3 and 12 months
measure: Cardiac symptoms
timeFrame: 1, 3 and 12 months
measure: Well-being
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Javier E Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: