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Neurocognitive DisordersNCT04178564

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

A study testing Cognitive Stimulation in people with Neurocognitive Disorders and Dementia, run by Rsocialform - Geriatria, Lda at 8 sites in Portugal.

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Paused. Enrolment is on hold for now and may resume.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Cognitive Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
8 sitesPortugal
Study dates
10 Feb 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Portugal8 sites

  • Rsocialform - Geriatria, Lda.

    Mealhada, Aveiro District, 3050-387

  • Associação de Solidariedade Social do Silveiro

    Oliveira do Bairro

  • Associação dos Amigos de Perrães

    Oliveira do Bairro

  • Centro Ambiente para Todos

    Oliveira do Bairro

  • Centro Social de Oiã

    Oliveira do Bairro

  • Centro Social Paroquial de S.Pedro da Palhaça

    Oliveira do Bairro

  • Santa Casa da Misericórdia de Oliveira do Bairro

    Oliveira do Bairro

  • Sóbustos

    Oliveira do Bairro

Other trials in Portugal

About this study

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

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.

Read the 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.

Being tested
Cognitive Stimulation
Keywords
Neurocognitive Disorders, Dementia, Cognitive Impairment, Cognitive Decline, Elderly, Cognitive Stimulation, Group Intervention, Cognition, Depression
Medical subject headings
Neurocognitive Disorders, Dementia, Cognitive Dysfunction, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive StimulationBehavioural

    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.

Study groups in NCT04178564
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention 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.
Receives: Behavioral: Cognitive Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive functioning evaluated through Mini-Mental State Examination

    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.

    Measured: Time Frame: Pre, intra (6 months) and post intervention (12 months)

  2. Cognitive functioning evaluated through Frontal Assessment Battery

    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.

    Measured: Time Frame: Pre, intra (6 months) and post intervention (12 months)

Secondary outcomes (1)

  1. Mood evaluated through Geriatric Depression Scale -15

    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.

    Measured: Time Frame: Pre, intra (6 months) and post intervention (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start10 Feb 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Why it stopped: Covid-19 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178564
Sponsor's protocol ID
14112019
Status last verified
Apr 2022
First submitted
22 Nov 2019
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Apostolo JL, Cardoso DF, Rosa AI, Paul C. The effect of cognitive stimulation on nursing home elders: a randomized controlled trial. J Nurs Scholarsh. 2014 May;46(3):157-66. doi: 10.1111/jnu.12072. Epub 2014 Mar 5.

    PubMed 24597922

  • Apóstolo JL, Loureiro LMJ, Carvalho IA, Alves I, Batista DF, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referencia 3: 65-73, 2014. doi:10.12707/RIV14033

  • Apóstolo JLA, Bobrowicz-Campos EM, dos Reis IAC, Henriques SJ, Correia CAV. Exploring the screening capacity of the European Portuguese version of the 15-item Geriatric Depression Scale. Revista de Psicopatología y Psicología Clínica 23: 99-107, 2018. doi: 10.5944/rppc.vol.23.num.2.2018.21050

  • Clare L, Wilson BA, Carter G, Breen K, Gosses A, Hodges JR. Intervening with everyday memory problems in dementia of Alzheimer type: an errorless learning approach. J Clin Exp Neuropsychol. 2000 Feb;22(1):132-46. doi: 10.1076/1380-3395(200002)22:1;1-8;FT132.

    PubMed 10649552

  • Clare L, Woods RT. Cognitive training and cognitive rehabilitation for people with early-stage Alzheimer's disease: a review. Neuropsychological Rehabilitation 14: 385-401, 2004

  • Costa ARD, Sequeira C. Efetividade de um Programa de Estimulação Cognitiva em Idosos com Défice Cognitivo Ligeiro. Revista Portuguesa de Enfermagem de Saúde Mental 9: 14-20, 2013

  • Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. doi: 10.1097/00002093-200101000-00001.

    PubMed 11236819

  • Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

    PubMed 11113214

  • Filipin F, Feldman M, Taragano FE, Martelli M, Sánchez V, García V, Tufro G, Heisecke S, Serrano C, Dillon, C. The Efficacy of Cognitive Stimulation on Depression and Cognition in Elderly Patients with Cognitive Impairment: A Retrospective Cohort Study. AIMS Medical Science 3 (1): 1-14, 2015

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Freitas S, Simoes MR, Alves L, Santana I. The Relevance of Sociodemographic and Health Variables on MMSE Normative Data. Appl Neuropsychol Adult. 2015;22(4):311-9. doi: 10.1080/23279095.2014.926455. Epub 2014 Dec 22.

    PubMed 25531579

  • Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia C. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia 1 (9): 9-10, 1994

  • Hall L, Orrell M, Stott J, Spector A. Cognitive stimulation therapy (CST): neuropsychological mechanisms of change. Int Psychogeriatr. 2013 Mar;25(3):479-89. doi: 10.1017/S1041610212001822. Epub 2012 Nov 12.

    PubMed 23146408

  • Justo-Henriques SI, Marques-Castro AE, Otero P, Vazquez FL, Torres AJ. [Long-term individual cognitive stimulation program in patients with mild neurocognitive disorder: a pilot study]. Rev Neurol. 2019 Apr 1;68(7):281-289. doi: 10.33588/rn.6807.2018321. Spanish.

    PubMed 30906977

  • Lima CF, Meireles LP, Fonseca R, Castro SL, Garrett C. The Frontal Assessment Battery (FAB) in Parkinson's disease and correlations with formal measures of executive functioning. J Neurol. 2008 Nov;255(11):1756-61. doi: 10.1007/s00415-008-0024-6. Epub 2008 Sep 25.

    PubMed 18821046

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Stimulation in people with Neurocognitive Disorders and Dementia, run by Rsocialform - Geriatria, Lda at 8 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive functioning evaluated through Mini-Mental State Examination (time frame: Time Frame: Pre, intra (6 months) and post intervention (12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178564, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.

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