Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Since MCI represents a risk factor for progression to various forms of dementia, timely preventive intervention is essential, although outpatient cognitive rehabilitation for this population is still limited by issues related to service accessibility. This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice. The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, with the aim of identifying potential predictors of a greater response to the intervention. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire. The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups, with two 60-minute sessions per week over 12 weeks. The intervention was designed to enhance accessibility and sustainability by limiting intervention intensity and duration, using technology, and delivering group-based rehabilitation in groups that are not highly homogeneous. This approach is expected to result in a better cost-benefit balance and greater transferability to clinical practice. The control group will receive an informational booklet on neuroprotective factors, including practical daily-life recommendations to reduce risk profiles. Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group. Participants in the experimental group will be further divided into small subgroups based on the presence of memory impairment.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Montreal Cognitive Assessment (MoCA) score
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Forward Digit span
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Copy of the Modified Taylor Complex Figure
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Rey Auditory Verbal Learning Test (RAVLT)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Boston Naming Test (BNT)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Multiple Features Target Cancellation (MFTC)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Raven's Colored Progressive Matrices (CPM)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Semantic and phonemic fluency
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Trail Making Test (TMT)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Weigl sorting test (WST)
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Stroop color word test
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Questionnaire on lifestyle
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Forward Corsi span.
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Backward Digit span.
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Backward Corsi span
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Free recall of the Modified Taylor Complex Figure
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Recognition of the Modified Taylor Complex Figure
Timeframe: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).