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

April 29, 2022 updated by: Rsocialform - Geriatria, Lda

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Oliveira do Bairro, Portugal
        • Associação de Solidariedade Social do Silveiro
      • Oliveira do Bairro, Portugal
        • Associação dos Amigos de Perrães
      • Oliveira do Bairro, Portugal
        • Centro Ambiente para Todos
      • Oliveira do Bairro, Portugal
        • Centro Social de Oiã
      • Oliveira do Bairro, Portugal
        • Centro Social Paroquial de S.Pedro da Palhaça
      • Oliveira do Bairro, Portugal
        • Santa Casa da Misericórdia de Oliveira do Bairro
      • Oliveira do Bairro, Portugal
        • Sóbustos
    • Aveiro
      • Mealhada, Aveiro, Portugal, 3050-387
        • Rsocialform - Geriatria, Lda.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a diagnosis of neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorder.
  • Having a score between 2 and 5 according to the Global Deterioration Scale (obtained from the participant's score on Mini-Mental State Examination).
  • Age over 60 years old.
  • Attending one of the institutions participating in the study.

Exclusion Criteria:

  • To have received psychological or psychiatric care in the last two months.
  • Not being able to communicate and understand.
  • To suffer from an acute or severe illness that makes their participation in the sessions impossible.
  • Sensory and physical limitation that prevent their participation in the sessions.
  • Limited attention span that prevents attending a one-hour group session.
  • Presence of severe neuropsychiatric symptoms that prevent their participation in the sessions or uncontrolled delirium.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Intervention group will receive 47 sessions of group CS and participate in 3 evaluation sessions. The CS program will last 1 year and each group CS session will last approximately 60 minutes.
Behavioral: Cognitive Stimulation

The intervention includes 50 sessions, over the course of one year, being that 3 of those sessions will be the pretest, intratest and posttest evaluations. The intervention sessions will last approximately 60 minutes and they will be developed according to the following structure:

Welcoming to the group (5 minutes) Reality orientation therapy (10 minutes) Main activity (35 minutes) Session evaluation (10 minutes) CS sessions will be conducted in groups. The intervention sessions will include several activities based on different non-pharmacological therapies, whose effectiveness in elderly with neurocognitive disorders has been scientifically proven. Non-pharmacological therapies used encompass therapies such as musictherapy, reminiscence therapy, validation therapy, Montessori method in geriatrics, ADL training, art therapy and the computer software Rehacom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functioning evaluated through Mini-Mental State Examination
Time Frame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and post-intervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Time Frame: Pre, intra (6 months) and post intervention (12 months)
Cognitive functioning evaluated through Frontal Assessment Battery
Time Frame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and post-intervention assessments. Frontal Assessment Battery is a screening test for executive functioning. Assesses conceptualization, lexical fluency, programming or motor series, sensitivity to interference, inhibitory control and environmental autonomy. Each subtest is scored from 0-3 points and global score ranges from 0-18 points. A higher score indicates a better executive function.
Time Frame: Pre, intra (6 months) and post intervention (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood evaluated through Geriatric Depression Scale -15
Time Frame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and post-intervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as apetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Time Frame: Pre, intra (6 months) and post intervention (12 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data collected through a sociodemographic questionnaire
Time Frame: Time Frame: Pre-intervention
Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.
Time Frame: Pre-intervention
Adherence to the intervention and dropouts evaluated through a session form
Time Frame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.
Time Frame: Pre, intra (6 months) and post intervention (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rsocialform - Geriatria, Lda

Investigators

  • Principal Investigator: Patricia Otero Otero, PhD, University of A Coruna
  • Principal Investigator: Susana I Justo Henriques, PhD, Replicar Socialform and University of de Santiago de Compostela
  • Principal Investigator: Vanessa Blanco Seoane, PhD, University of de Santiago de Compostela
  • Principal Investigator: Fernando L Vázquez González, PhD, University of de Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14112019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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