A Study of Positive Emotions With Long COVID-19

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Behavioral: Microdosing of mindfulness

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Behavioral: Microdosing 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.
No Intervention: Waitlist control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Javier E Lopez, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1840049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No