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Идёт набор NCT07140094

Long-Covid-19 Alleviation Through Learning Mindfulness Study

Без фазы С лечением Long COVID Long Covid19 Post-Acute COVID-19 Post-Acute COVID-19 Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Structured mindfulness intervention.
Кому может быть актуально
Состояния в реестре: Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Long-Covid-19 Alleviation Through Learning Mindfulness Study (LONG-CALM)

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score [Срок оценки: Month 2]
Вторичные конечные точки (7)
  • Change in PROMIS Global 10 Score [Срок оценки: Months 1, 2, 6]
  • Post-Acute Sequelae of SARS-CoV-2 (PASC) Score [Срок оценки: Months 1, 2, 6]
  • Patient Health Questionnaire 9 (PHQ9) Score [Срок оценки: Months 1, 2, 6]
  • Generalized Anxiety Disorder 7 (GAD7) Score [Срок оценки: Months 1, 2, 6]
  • Impact of Event 6 (IES-6) Scores [Срок оценки: Months 1, 2, 6]
  • State Mindfulness Scale for Physical Activity Score [Срок оценки: Months 1, 2, 6]
  • Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score [Срок оценки: Months 1 and 6]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Participating in another clinical trial of an intervention for PASC symptoms
  • Engaged in a structured MBI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Columbia University — New York

Публикации

  • 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

Идентификаторы

NCT: NCT07140094 · AAAT0564

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗