Long-Covid-19 Alleviation Through Learning Mindfulness Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured mindfulness intervention.
- Who it may be relevant to
- Registry conditions: Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-Covid-19 Alleviation Through Learning Mindfulness Study (LONG-CALM)
Overview
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
- Behavioral Structured 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.
Primary outcome measures
- Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score [Time frame: Month 2]
Secondary outcome measures (7)
- Change in PROMIS Global 10 Score [Time frame: Months 1, 2, 6]
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Score [Time frame: Months 1, 2, 6]
- Patient Health Questionnaire 9 (PHQ9) Score [Time frame: Months 1, 2, 6]
- Generalized Anxiety Disorder 7 (GAD7) Score [Time frame: Months 1, 2, 6]
- Impact of Event 6 (IES-6) Scores [Time frame: Months 1, 2, 6]
- State Mindfulness Scale for Physical Activity Score [Time frame: Months 1, 2, 6]
- Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score [Time frame: Months 1 and 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University — New York
Publications
- Thaweethai T, Jolley SE, Karlson EW, Levitan EB, Levy B, McComsey GA, McCorkell L, Nadkarni GN, Parthasarathy S, Singh U, Walker TA, Selvaggi CA, Shinnick DJ, Schulte CCM, Atchley-Challenner R, Alba GA, Alicic R, Altman N, Anglin K, Argueta U, Ashktorab H, Baslet G, Bassett IV, Bateman L, Bedi B, Bhattacharyya S, Bind MA, Blomkalns AL, Bonilla H, Brim H, Bush PA, Castro M, Chan J, Charney AW, Chen PMID 37278994
Identifiers
NCT: NCT07140094 · AAAT0564