Immediate and Long Term Cognitive Improvement After Cognitive Versus Emotion Management Psychoeducation Programs: a Randomised Trial in Covid Patients With Neuropsychological Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Comparison of change in subjective cognitive difficulties between the two intervention arms
研究概览
简要总结
The purpose of the study is to explore the potential effectiveness of two common low-dose interventions, one targeting cognitive difficulties and the other targeting affective difficulties on quality of life and cognition in people suffering from long-COVID with cognitive complaints.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects able to understand the information and consent forms;
- •Medically stable and at least 3 months after positive PCR for Covid-19;
- •Self-reported sufficiently good physical condition to attend the appointment;
- •No major hearing or vision disorders;
- •Cognitive complaints that place the person in the top 20% of dissatisfied functioning on the BRIEF or MMQ questionnaires;
- •Poor objective performance supported by a score below the 20th percentile on one task of the cognitive battery.
排除标准
- •Any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
- •Cognitive impairment (minor or major neurocognitive disorder; intellectual disability) preexisting to the Covid-19 episode;
- •Acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
- •Documented preexisting history of psychiatric illness, including substance abuse; Open-heart cardiac surgery or cardiac arrest during the last 6 months;
- •Current hospitalization;
- •Current revalidation care with cognitive treatment
研究组 & 干预措施
Cognitive psychoeducation
1) The cognitive intervention is a 4-session, psycho-educative, integrative and multidimensional intervention designed to prevent post-acute cognitive symptoms. Each individual session will last 90' and will concern a specific cognitive domain:
- Cognition in covid, fatigue and sleep
- Working memory and attentional functioning
- Executive functioning
- Memory functioning
The structure of the sessions will be similar: (1) explanation about (dys)functioning of processes associated to the domain of interest: (2) identification of problems in daily life translated into functional objectives (e.g. keeping papers organized; scheduling activities to avoid fatigue); (3) discovery and application of (meta)cognitive strategies.
Material (videos, tips,…) will be provided that the patients can consult when needed. The patients will have a diary to complete to explain when they applied the content of the intervention in daily life, and how successful it was.
干预措施: Psychoeducation (Behavioral)
Affective psychoeducation
2) The affective intervention is also a psychoeducation program based on four sessions, in which different strategies and resources will be proposed to increase self-efficacy for emotion management:
- Recognizing emotions and affective states
- Accepting and communicating emotions and difficulties
- Accepting the uncertainty associated with difficulties
- Behavioural activation
Material (videos, tips,…) will be provided that the patients can consult when needed. The patients will have a diary to complete to explain when they applied the content of the intervention in daily life, and how successful it was.
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Comparison of change in subjective cognitive difficulties between the two intervention arms
时间窗: Two months post-intervention
Subjective report of difficulties experienced by patients in daily life: BRIEF (Behavioral Rating Inventory of Executive Function) and MMQ (Multifactorial Memory Questionnaire) questionnaires. The BRIEF summary index scales (Behavioral Regulation Index and Metacognition Index) and the scale reflecting overall functioning (Global Executive Composite) are expressed at t-scores (M=50, SD=10) ranging from 30 to 100. Higher scores indicates better outcome. There are three scales in the MMQ : Satisfaction Scale, Ability Scale and Strategy Scale. The individual score will range from 0 to 72, from 0 to 80 and from 0 to 76 respectively for each scale. Higher scores indicate better ratings.
次要结局
- Comparison of change in quality of life assessment between the two intervention arms(2 and 8 months post-intervention)
- Comparison of changes in cognitive performance between the two intervention arms(2 and 8 months post-intervention)
- Comparison of change in subjective cognitive difficulties between the two intervention arms(Eight months post-intervention)
研究者
Fabienne COLLETTE
Research Director
University of Liege