Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
研究概览
简要总结
Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs). Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study was designed to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. The study is a randomized controlled trial (RCT), comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent cognitive sequela in post-COVID-19 condition. The study originally aimed to recruit 240 participants (120 per group). A total of 135 participants were enrolled, of whom 129 participants completed baseline assessments and were randomized to either group-based GMT (GMT; n = 64) or wait-list control (WL; n = 65), all aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis. GMT was internet-delivered to groups of 4-7 participants in six weekly two-hour sessions. The primary outcome was the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, at six months post-treatment. Secondary outcomes included performance-based neurocognitive measures and rating scales of cognition, emotional health, quality of life, and fatigue.
Secondary aims include to explore to what extent potential early change predicts outcome, and to examine what characterize those who profit from GMT, in addition to describe the neurocognitive and emotional health in a Covid-19 sample. The investigators will also examine potential long-term effects of GMT at 2- and 4-year follow-up.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of laboratory- or home-test confirmed, SARS-CoV-2 infection
- •perceived cognitive difficulties (attention, memory, EF) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis
- •age between 18-65 years
排除标准
- •ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in Norwegian, and being previously enrolled in a GMT trial.
研究组 & 干预措施
Wait list
Wait list control condition
Goal Management Training (GMT)
Internet-delivered group-based GMT to groups of 4-7 participants in six two-hour sessions delivered weekly. Manualized intervention.
干预措施: Goal Management Training (GMT) (Behavioral)
结局指标
主要结局
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
时间窗: Change from baseline up to 6 months
Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.
次要结局
- The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)(Change from baseline to 6 months, 2 years, and 4 years)
- Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge(Change from baseline to 6 months, 2 years, and 4 years)
- The Hospital Anxiety and Depression Scale(Change from baseline to 6 months, 2 years, and 4 years)
- The Generalized Self-Efficacy Scale(Change from baseline to 6 months, 2 years, and 4 years)
- Fatigue Severity Scale(Change from baseline to 6 months, 2 years, and 4 years)
- The Perceived Deficits Questionnaire(Change from baseline to 6 months, 2 years, and 4 years)
- Everyday Memory Questionnaire(Change from baseline to 6 months, 2 years, and 4 years)
- RAND 12-Item Health Survey (RAND-12)(Change from baseline to 6 months, 2 years, and 4 years)
- EuroQol five-dimension scale questionnaire (EQ-5D)(Change from baseline to 6 months, 2 years, and 4 years)
- The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)(Change from baseline to 2 years and 4 years)
- DePaul Symptom Questionnaire short version(Change from baseline up to 6 months)
- Insomnia Severity Index(Change from baseline up to 6 months)