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A Study of Positive Emotions With Long COVID-19

Not Applicable
Active, not recruiting
Conditions
Post-Acute COVID-19 Syndrome
Interventions
Behavioral: Microdosing of mindfulness
Registration Number
NCT05676008
Lead Sponsor
University of California, Davis
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
400
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TreatmentMicrodosing of mindfulness-
Primary Outcome Measures
NameTimeMethod
Well-being1 month

14 items from the Mental Health Continuum Short Form

Secondary Outcome Measures
NameTimeMethod
Depressive symptoms1, 3 and 12 months

Beck Depression Inventory Short Form

Perceived Stress1, 3 and 12 months

Perceived Stress Scale

Physical health1, 3 and 12 months

Physical health symptoms - 11 items + 3 items of COVID symptoms

Anxiety symptoms1, 3 and 12 months

Generalized Anxiety Disorder scale

Well-being3 and 12 months

14 items from the Mental Health Continuum Short Form

Cardiac symptoms1, 3 and 12 months

Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12)

Trial Locations

Locations (1)

University of California Davis

🇺🇸

Sacramento, California, United States

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