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 cogniti…
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.
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of MCI according to the diagnostic criteria of Petersen (2004) and Winblad et al. (2004) and, if applicable (i.e., MCI due to AD), according to those of Albert and colleagues (2011).
* Self-reported basic skills in using technological devices, or access to a close pe…
Inclusion Criteria:
* Diagnosis of MCI according to the diagnostic criteria of Petersen (2004) and Winblad et al. (2004) and, if applicable (i.e., MCI due to AD), according to those of Albert and colleagues (2011).
* Self-reported basic skills in using technological devices, or access to a close person able to provide assistance.
* Willingness of the patient to report, during the study period, any changes in the dosage of psychotropic drugs or other medications that may affect cognition, such as anticholinergics, opioids, benzodiazepines, antidepressants, muscle relaxants, and antiepileptics.
Exclusion Criteria:
* Parkinson's disease.
* Linguistic single-domain MCI (suspected onset of primary progressive aphasia).
* Other neurological conditions potentially associated with cognitive impairment (e.g., previous stroke or traumatic brain injury).
* Significant laboratory abnormalities potentially associated with cognitive impairment (e.g., low levels of vitamin B12 or folate, or values indicative of thyroid disorders).
* Primary psychiatric disorders.
* Alcohol or substance use disorder in the previous 10 years.
* Severe behavioral disturbances limiting group participation.
* Hearing or visual impairments that may interfere with assessment or treatment.
* Medical conditions that may interfere with completion of the study.
* Exposure, during the study period, to other neuropsychological rehabilitation interventions.
* Patient's refusal to sign the informed consent.
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