Mild Cognitive Impairment and Psychopathology: Effects on Awareness, Social Life, and Work. Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 118
研究概览
简要总结
Mild Cognitive Impairment (MCI) is a condition characterized by cognitive deterioration greater than what is expected from normal aging, representing an important risk factor for the development of dementia. Early assessment of cognitive functions is therefore essential for promptly identifying any signs of decline. In addition to cognitive aspects, it is equally important to consider the possible psychopathological profile of patients, as such disorders can significantly influence the progression of the disease, quality of life, and the ability to manage daily activities. This protocol aims to explore the presence of psychopathological disorders in patients with MCI, with particular attention to their impact on awareness of cognitive deficits (anosognosia) and on the subjective perception of difficulties in daily life, especially in social and work contexts. The study seeks to outline a comprehensive picture of the psychopathological profile in patients with MCI, facilitating the identification of targeted and personalized interventions capable of improving clinical management and the overall well-being of the individual.
详细描述
The study has a cross-sectional observational design, with data collected at a single time point (T0). The overall duration of the study, estimated at approximately 12 months, will depend on the time required to complete participant enrollment, data analysis, and dissemination of results. The purpose of this protocol is to investigate the presence of psychopathological disorders in patients with Mild Cognitive Impairment (MCI), with particular attention to their impact on awareness of cognitive deficits (anosognosia) and on the ability to cope with difficulties in social and work-related activities.
In this context, the study aims to outline a broader and more structured picture of the psychopathological profile of patients with MCI. This perspective will make it possible to analyze the interactions between emotional aspects, personality characteristics, and cognitive decline, with the goal of identifying more targeted and personalized intervention strategies capable of improving clinical management and promoting overall well-being.
The primary objective is to assess the presence of psychopathological disorders in patients with Mild Cognitive Impairment (MCI). The secondary objectives are to examine the impact of psychopathological disorders on the level of awareness of one's cognitive decline (partial or total anosognosia) and to evaluate how such disorders affect daily life by comparing the subjective perception of difficulties in social and work contexts.
As this is a cross-sectional observational study involving a single group of MCI patients, the sample size was estimated a priori using G*Power 3.1 with a one-sample binomial test (two-tailed) for the primary objective, the estimation of the prevalence of psychopathological disorders. Based on the literature, an expected prevalence of p1 = 0.20 was assumed, to be compared with a reference value of p2 = 0.32 (α = 0.05; power 1-β = 0.85), resulting in an estimated sample size of N = 118 subjects. Considering a 15% margin for possible drop-outs or invalid data, the final sample size was set at N = 136 participants.
Subjects will be included in the study if, based on available clinical documentation, they meet the following requirements: age between 50 and 72 years; diagnosis of Mild Cognitive Impairment (MCI), referred to the Neuropsychology Clinic for an initial evaluation or clinical follow-up; absence of behavioral, psychiatric, or sensory disorders severe enough to significantly compromise the performance of cognitive tests or the completion of questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 72 years;
- •Diagnosis of Mild Cognitive Impairment (MCI), with referral to the Neuropsychology clinic for an initial evaluation or for clinical monitoring;
- •Absence of behavioral, psychiatric, or sensory disorders that could significantly compromise the performance of cognitive tests or the completion of questionnaires.
排除标准
- •Neurological disorders other than MCI, such as recent stroke, severe traumatic brain injury, epilepsy, multiple sclerosis, or other atypical neurodegenerative diseases;
- •Major psychiatric comorbidities not stabilized at the time of the assessment (e.g., schizophrenia, bipolar disorder in an active phase, untreated severe depression);
- •Severe uncorrected sensory deficits (visual or hearing) capable of compromising the validity of cognitive and functional assessments;
- •Use of medications with significant potential cognitive impact (e.g., sedatives, high-dose antipsychotics) not stabilized at the time of the assessment;
- •Terminal-stage internal or oncological diseases, or other medical conditions that significantly interfere with the assessment procedures.
研究者
Irene Cappadona
PSYCHOLOGIST
IRCCS Centro Neurolesi Bonino Pulejo