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A Study of Positive Emotions With Long COVID-19

Primary Purpose

Post-Acute COVID-19 Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microdosing of mindfulness
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-Acute COVID-19 Syndrome focused on measuring Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist control

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Well-being
14 items from the Mental Health Continuum Short Form

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2022
Last Updated
May 10, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05676008
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome
Keywords
Mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waitlist control
Arm Type
No Intervention
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Microdosing of mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Well-being
Description
14 items from the Mental Health Continuum Short Form
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Perceived Stress
Description
Perceived Stress Scale
Time Frame
1, 3 and 12 months
Title
Anxiety symptoms
Description
Generalized Anxiety Disorder scale
Time Frame
1, 3 and 12 months
Title
Depressive symptoms
Description
Beck Depression Inventory Short Form
Time Frame
1, 3 and 12 months
Title
Physical health
Description
Physical health symptoms - 11 items + 3 items of COVID symptoms
Time Frame
1, 3 and 12 months
Title
Cardiac symptoms
Description
Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12)
Time Frame
1, 3 and 12 months
Title
Well-being
Description
14 items from the Mental Health Continuum Short Form
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier E Lopez, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Positive Emotions With Long COVID-19

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