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Набор по приглашению NCT06086379

Cognitive Rehabilitation Therapy for COVID-19

Без фазы С лечением 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: Compensatory Cognitive Training for COVID-19, Holistic Cognitive Education.
Кому может быть актуально
Состояния в реестре: 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19

Обзор

Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability following COVID-19 negatively impact Veterans' community functioning and quality of life, contribute to significant human suffering, and are costly to VHA. Rehabilitation is a critical priority for Veterans with long COVID. One promising treatment to improve functioning in Veterans with post-COVID-19 cognitive symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. This randomized controlled trial aims to address important RR\&D priorities by examining feasibility, acceptability, and preliminary efficacy of a COVID-19-specific rehabilitation intervention, CCT for long COVID (CCT-C) compared to a robust control condition. The proposed study has the potential to improve cognitive function, functional independence, and quality of life for Veterans with late or delayed effects of secondary conditions related to COVID-19 infections.

Подробное описание

2-8% of the US population report "long COVID" symptoms - including "brain fog," thinking difficulties, memory problems, and psychiatric symptoms such as sleep disturbance, anxiety, and depression. Rates of post-COVID-19 symptoms are nearly double in the Veteran population. These cognitive symptoms contribute to functional impairments, reduced quality of life, poorer self-reported health status, psychological distress, delayed return to work, new onset disability, reduced community integration, and increased healthcare utilization. One promising treatment to improve both everyday functioning and cognition secondary to post-COVID-19 symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. The proposed CDA provides a golden opportunity to evaluate CCT for Veterans with prolonged COVID-19 symptoms (CCT-C), compared with a robust control condition, Holistic Cognitive Education (HCE). The project closely aligns with current RR\&D priorities, by "examining COVID-19-specific rehabilitation interventions and responses to treatment" and by addressing "late or delayed effects of secondary conditions related to COVID-19 infections on impairment and disability." Specific aims are 1) to conduct a pilot randomized controlled trial of remote CCT-C with 70 Veterans (35 CCT-C, 35 HCE) with post-COVID-19 cognitive symptoms to examine feasibility, acceptability, and initial efficacy; 2) to examine the preliminary efficacy of CCT-C in this population on overall functioning, as measured by the World Health Organization's Disability Assessment Schedule (WHODAS 2.0), performance-based measures of functional capacity, and secondary outcomes (cognitive performance, quality of life, self-reported cognitive problems, psychiatric symptoms, sleep disturbance, and engagement in work/community activities); and 3) to explore moderators of outcome (e.g., age, initial COVID-19 severity, baseline cognitive functioning, presence of PTSD/mTBI history; biomarkers related to COVID-19 infection).

Вмешательства

  • Поведенческое Compensatory Cognitive Training for COVID-19
    CCT-C is a manualized group-based behavioral intervention (10 weeks, 2 hours per week, 20 hours total) designed to improve cognition and everyday functioning in patients with prolonged COVID-19 symptoms
  • Поведенческое Holistic Cognitive Education
    HCE provides the same frequency and amount of therapist and other group member contact as CCT-C, but does not provide training in cognitive or lifestyle strategies addressed in CCT-C. The HCE intervention provides information and discussion regarding common causes of and treatments for cognitive impairment.

Первичные конечные точки

  • Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0) [Срок оценки: baseline, 8 weeks]
Вторичные конечные точки (11)
  • Change in objective cognitive performance z score [Срок оценки: baseline, 8 weeks]
  • Change in functional capacity performance z score [Срок оценки: baseline, 8 weeks]
  • Change in Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: baseline, 8 weeks]
  • Change in Generalized Anxiety Disorder 7 (GAD-7) [Срок оценки: baseline, 8 weeks]
  • Change in PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: baseline, 8 weeks]
  • Change in Cognitive Failures Questionnaire (CFQ) [Срок оценки: baseline, 8 weeks]
  • Change in Neuro-QOL: Applied Cognition General Concerns [Срок оценки: baseline, 8 weeks]
  • Change in Neuro-QOL: Applied Cognition Executive Functioning [Срок оценки: baseline, 8 weeks]
  • Change in Neuro-QOL: Fatigue [Срок оценки: baseline, 8 weeks]
  • Change in World Health Organization - Quality of Life (WHOQOL-BREF) [Срок оценки: baseline, 8 weeks]
  • Change in Insomnia Severity Index (ISI) [Срок оценки: baseline, 8 weeks]

Критерии участия

Критерии включения

  • Veterans > 18 years old who are able to provide informed consent
  • Prior participation in SF Parent Study or LA Parent Study
  • Report of cognitive symptoms that Veteran attributes to COVID-19 infection

Критерии исключения

  • Current substance abuse disorder, psychotic disorder, dementia, etc.
  • History of moderate to severe brain injury with loss of consciousness > 30 minutes
  • Auditory or visual impairments that would prevent the ability to participate in assessment procedures
  • Invalid performance on one or more embedded performance validity tests (PVTs)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • VA San Diego Healthcare System, San Diego, CA — San Diego

Идентификаторы

NCT: NCT06086379 · E4764-W

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗