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临床试验/NCT06086379
NCT06086379Enrolling By Invitation不适用

Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
70
试验地点
1
主要终点
Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessors will be blind to treatment group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

HCE

Active Comparator

10-week Holistic Cognitive Education Group

干预措施: Holistic Cognitive Education (Behavioral)

CCT-C

Experimental

10-week Compensatory Cognitive Training Group

干预措施: Compensatory Cognitive Training for COVID-19 (Behavioral)

结局指标

主要结局

Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)

时间窗: baseline, 8 weeks

Change in average total score

次要结局

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

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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