Clinical trial NCT04178564: Major Memory 2: A Long-term Group Cognitive Stimulation Program
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Neurocognitive Disorders
Dementia
Cognitive Impairment
Cognitive Decline
Keywords: Neurocognitive Disorders
Dementia
Cognitive Impairment
Cognitive Decline
Elderly
Cognitive Stimulation
Group Intervention
Cognition
Depression
Lead sponsor: Rsocialform - Geriatria, Lda
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive functioning evaluated through Mini-Mental State Examination
timeFrame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
measure: Cognitive functioning evaluated through Frontal Assessment Battery
timeFrame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Secondary outcomes:
measure: Mood evaluated through Geriatric Depression Scale -15
timeFrame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Other outcomes:
measure: Sociodemographic data collected through a sociodemographic questionnaire
timeFrame: Time Frame: Pre-intervention
measure: Adherence to the intervention and dropouts evaluated through a session form
timeFrame: Time Frame: Pre, intra (6 months) and post intervention (12 months)
Locations:
city: Mealhada
country: Portugal
facility: Rsocialform - Geriatria, Lda.
state: Aveiro
city: Oliveira do Bairro
country: Portugal
facility: Associação de Solidariedade Social do Silveiro
city: Oliveira do Bairro
country: Portugal
facility: Associação dos Amigos de Perrães
city: Oliveira do Bairro
country: Portugal
facility: Centro Ambiente para Todos
city: Oliveira do Bairro
country: Portugal
facility: Centro Social de Oiã
city: Oliveira do Bairro
country: Portugal
facility: Centro Social Paroquial de S.Pedro da Palhaça
city: Oliveira do Bairro
country: Portugal
facility: Santa Casa da Misericórdia de Oliveira do Bairro
city: Oliveira do Bairro
country: Portugal
facility: Sóbustos
Study officials:
affiliation: Replicar Socialform and University of de Santiago de Compostela
name: Susana I Justo Henriques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of A Coruña
name: Patricia Otero Otero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of de Santiago de Compostela
name: Vanessa Blanco Seoane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of de Santiago de Compostela
name: Fernando L Vázquez González, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: Lobbia A, Carbone E, Faggian S, Gardini S, Piras F, Spector A, Borella E. The efficacy of cognitive stimulation therapy (CST) for people with mild-to-moderate dementia: A review. European Psychologist, 2018. doi:10.1027/1016-9040/a000342
citation: Loewenstein DA, Acevedo A, Czaja SJ, Duara R. Cognitive rehabilitation of mildly impaired Alzheimer disease patients on cholinesterase inhibitors. Am J Geriatr Psychiatry. 2004 Jul-Aug;12(4):395-402. doi: 10.1176/appi.ajgp.12.4.395.
citation: Melguizo Herrera E, Bertel De La Hoz A, Paternina Osorio D, Felfle Fuentes Y, Porto Osorio L. Cognitive Stimulation of Elderly Residents in Social Protection Centers in Cartagena, 2014. Rev Colomb Psiquiatr. 2017 Oct-Dec;46(4):229-236. doi: 10.1016/j.rcp.2016.09.008. Epub 2016 Nov 2.
citation: Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental Sate Examination. Sinapse 2 (9): 10-16, 2009
citation: Sheikh JI, Yesavage JA. Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist: The Journal of Aging and Mental Health 5 (1-2): 165-173, 1986
citation: Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
citation: Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychol Rehabil 12: 97-110, 2002
citation: Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2.
citation: Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982 Sep;139(9):1136-9. doi: 10.1176/ajp.139.9.1136.