COVID Long-Haul, Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Infection, Post-Acute COVID-19 Syndrome
Conditions
Keywords
Covid
Brief summary
This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Mindfulness is defined as paying attention to the present moment with non-judgment and acceptance. Here the investigators are studying whether a mindfulness intervention can help reduce stress, reduce Long COVID symptoms, and improve quality of life among people living with Long COVID. The mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. People who decide to take part will be randomly assigned to receive the study mindfulness intervention immediately after joining the study or to receive the study mindfulness intervention 8 weeks after joining the study. All participants will continue their usual medical care. Participants will complete online surveys to measure symptoms over time. The study will last 6 months.
Detailed description
Patients with COVID-19 disease who go on to develop Post-Acute Sequelae of SARS-CoV-2 infection (PASC) are under significant physical and psychosocial stress. Mindfulness, operationally defined as paying attention to the present moment with non-judgment and acceptance, is a candidate treatment to reduce stress in patients with PASC. Reducing stress is critical, as stress may trigger flares in PASC symptoms. Mindfulness-Based Interventions (MBIs), including Mindfulness-Based Stress Reduction, have been shown in clinical trials, and confirmed in meta-analytic studies, to improve physical and psychological indices of stress in a wide variety of clinical and non-clinical populations. Such studies suggest an MBI might be feasible and acceptable for patients with PASC and may improve PASC symptoms and quality of life. The investigator proposes to test whether an MBI among patients with PASC alleviates symptoms. The MBI is an 8-week online intervention that consists of a series of recorded mindfulness sessions that were developed specifically for people with PASC. The goal of the MBI is to reduce stress, reduce symptoms of PASC, and improve quality of life. Symptoms are assessed through the completion of online surveys (four surveys over 6 months). All participation is remote (no in-person study visits).
Interventions
BEHAVIORALStructured mindfulness intervention
The mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. The mindfulness recordings are between two and twenty minutes long and are accessed online.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> or = 18 * Willing and able to provide informed consent * Access to the internet * Self-reported history of SARS-CoV-2 infection * Current symptoms attributed to PASC by participant or by participant's medical provider; ongoing symptoms that persisted \>= 12 weeks after Covid-19 illness
Exclusion criteria
* Participating in another clinical trial of an intervention for PASC symptoms * Engaged in a structured MBI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score | Month 2 | This is to compare the difference between both groups at Month 2. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Global 10 Score | Months 1, 2, 6 | The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health. |
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Score | Months 1, 2, 6 | This study uses the PASC score defined by Thaweethai et al., JAMA, 2023. The PASC score is measured as the sum of the scores for each PASC symptom reported by a participant at the specified timepoint. See: doi:10.1001/jama.2023.8823. |
| Patient Health Questionnaire 9 (PHQ9) Score | Months 1, 2, 6 | The PHQ9 is a 9-item questionnaire measuring depression symptoms. The scores range from 0 to 27, with higher scores indicating greater severity. |
| Generalized Anxiety Disorder 7 (GAD7) Score | Months 1, 2, 6 | The GAD7 is a 7-item scale that measures anxiety symptoms. The scores range from 0 to 21, with higher scores indicating greater severity. |
| Impact of Event 6 (IES-6) Scores | Months 1, 2, 6 | IES-6 is a 6-item scale that measures post traumatic stress disorder (PTSD) symptoms. The scores range from 0 to 18, with higher scores indicating greater severity. |
| State Mindfulness Scale for Physical Activity Score | Months 1, 2, 6 | The State Mindfulness Scale for Physical Activity Score measures mindfulness after physical activity. There are twelve questions, each scored between 0-4. The scores for each question are summed and then divided by 12. A higher score indicates a greater degree of mindfulness. |
| Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score | Months 1 and 6 | Mean score difference in health-related quality of life, as measured by PROMIS Global 10 criteria. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health. |
Countries
United States
Contacts
CONTACTDeborah Theodore, MD
PRINCIPAL_INVESTIGATORDeborah Theodore, MD
Columbia University
Outcome results
None listed