Major Memory 2: A Long-term Group Cognitive Stimulation Program

Dementia Clinical Trial

Official title: Major Memory 2: A Long-term Group Cognitive Stimulation Program for Patients With Neurocognitive Disorders Attending Social Responses in Oliveira do Bairro Municipality

Status Suspended

Clinical Trial Summary

This study aims to evaluate the effect of a long-term group cognitive stimulation (CS) program on the cognitive function of institutionalized elderly people with neurocognitive disorders. The study also aims to assess the program's feasibility in institutions located in the Portuguese town of Oliveira do Bairro.

The investigators propose the realization of a quasi-experimental longitudinal study with a one-group pretest-posttest design. The subjects will participate in CS sessions as part of a group, once a week, for one year, while maintaining their usual care in the institution. The program will have 47 sessions, once per week, with 1 hour each. In each participating institution, one group will be formed. In groups composed by participants with mild neurocognitive disorder, the maximum number will be 10 participants per group, in groups composed by participants with major neurocognitive disorder, the maximum number will be 6 participants per group. In each institution, patients who meet the inclusion and exclusion criteria will be selected to become part of a cognitive stimulation group program.

Clinical Trial Description

At this moment, the world is experiencing an unprecedented population aging at a global scale. In 2050, the number of people over 65 years old will more than double from 617 million to 1,6 billion and the percentage of people over 65 years old will grow from 9% to 16%. Portugal is one of the fastest aging countries in the world, 22% of its population is over 65 years of age.

With the increase of the elderly population, new challenges arise such as the increased prevalence of neurocognitive disorders. According with estimates from OCDE, Portugal is the fourth country with the highest number of dementia diagnosis. This brings many social, health and economic costs to our country.

There is evidence that in the earlier stages of neurocognitive disorders, people can learn and improve their cognitive function through interventions, such as cognitive stimulation (CS). There are three types of cognitive intervention to improve cognitive performance: CS, cognitive rehabilitation and cognitive training. Cognitive rehabilitation is an individualized approach to improve cognitive impairment and enhance everyday functioning. Cognitive training is designed for the patient to perform a set of tasks to improve or maintain cognitive function through guided practice.

CS is an intervention where cognitive domains are not used in isolation but in an integrated manner. CS can be structured in an individual or group format. Individual CS therapy includes activities designed to stimulate cognition, conducted only with the therapist and the patient.

On the other hand, group CS is the "engagement in a range of group activities and discussions aimed at general enhancement of cognitive and social functioning".

In a study that applied individual CS therapy in institutionalized Portuguese patients with mild neurocognitive disorder, over the course of one year, it was found a significant improvement in the intervention group on cognitive performance and a significant reduction of depressive symptoms, with medium to large effect sizes, showing that CS therapy is effective in the individual format.

However, CS is also effective when conducted in groups. The results of a group CS therapy program conducted in a multicenter, single blind, randomized controlled trial, showed significant improvements on cognitive performance in the intervention group, specifically in the scores of Mini Mental State Examination and the cognitive subscale of the Alzheimer's Disease Assessment Scale.

Following this evidence, the National Institute for Health and Clinical Excellence has recommended structured Group CS as a non-pharmacological therapy for people with mild to moderate neurocognitive disorder.

In a systematic review about CS, studies showed strong evidence that CS has a positive impact on cognitive performance, depression, activities of daily living and behavior for people with neurocognitive disorders.

In a multicenter study conducted with a one-group design and 14 group CS sessions over the course of 7 weeks, in patients with mild to moderate dementia, results showed an improvement on cognitive domains, such as memory, language comprehension and orientation, but did not show significant changes on attention/working memory, executive function or praxis.

In another study, which involved conducting a 10 session cognitive stimulation program, each session lasting 2 hours, 3 times per week, with elderly living in social protection centers, it was also found a statistically significant improvement in the participants' cognitive functioning after the intervention.

Another study involved a multicenter investigation where a group CS program was applied to people with diagnosis of mild to moderate dementia. The program was based on the Making a Difference program of Spector et al. which has 14 bi-weekly sessions, over the course of 7 weeks. Results showed a significant improvement on cognitive functions and also in depressive symptomatology.

In a study carried out in Portugal, a group CS program for people with mild cognitive impairment, composed by 1 weekly session, lasting 90 minutes, for 8 weeks, obtained positive results. It concluded that short term memory, orientation, language and visuospatial orientation improved significantly in the intervention group in comparison with the control group.

Other portuguese authors also applied a group CS program, which was based on the Making a Difference Program, with 14 twice a week sessions, each lasting 45-60 minutes. This study found a significant improvement on cognitive functions in the participants of the intervention group.

Considering the previous information, this research proposition's goal is to evaluate the effect of group CS on cognitive performance and depressive symptomatology in institutionalized people with mild to major neurocognitive disorder. ;

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Neurocognitive Disorders

• NCT number: NCT04178564
• Study type: Interventional
• Source: Rsocialform - Geriatria, Lda
• Status: Suspended
• Phase: N/A
• Start date: February 10, 2020
• Completion date: December 31, 2022