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

NCT04178564 | Suspended

• 1 other identifier: 14112019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

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.

Conditions

Neurocognitive Disorders; Dementia; Cognitive Impairment; Cognitive Decline

Keywords

Neurocognitive Disorders; Dementia; Cognitive Impairment; Cognitive Decline; Elderly; Cognitive Stimulation; Group Intervention; Cognition; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Mood evaluated through Geriatric Depression Scale -15

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

Other Outcomes (2)

• Sociodemographic data collected through a sociodemographic questionnaire

  Time Frame: Pre-intervention

• Adherence to the intervention and dropouts evaluated through a session form

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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Cognitive Stimulation BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead

Study Sites (8)

Rsocialform - Geriatria, Lda.

Mealhada, Aveiro District, 3050-387, Portugal

Location

Associação de Solidariedade Social do Silveiro

Oliveira do Bairro, Portugal

Location

Associação dos Amigos de Perrães

Oliveira do Bairro, Portugal

Location

Centro Ambiente para Todos

Oliveira do Bairro, Portugal

Location

Centro Social de Oiã

Oliveira do Bairro, Portugal

Location

Centro Social Paroquial de S.Pedro da Palhaça

Oliveira do Bairro, Portugal

Location

Santa Casa da Misericórdia de Oliveira do Bairro

Oliveira do Bairro, Portugal

Location

Sóbustos

Oliveira do Bairro, Portugal

Location

Related Publications (24)

• 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.

  PMID: 24597922 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10649552 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11236819 BACKGROUND

• 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.

  PMID: 11113214 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 1202204 BACKGROUND

• 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.

  PMID: 25531579 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23146408 BACKGROUND

• 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.

  PMID: 30906977 BACKGROUND

• 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.

  PMID: 18821046 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15249277 BACKGROUND

• 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.

  PMID: 29122230 BACKGROUND

• Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental Sate Examination. Sinapse 2 (9): 10-16, 2009

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12948999 BACKGROUND

• Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychol Rehabil 12: 97-110, 2002

  BACKGROUND

• 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.

  PMID: 22336813 BACKGROUND

• 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.

  PMID: 7114305 BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders; Dementia; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Susana I Justo Henriques, PhD

  Replicar Socialform and University of de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Patricia Otero Otero, PhD

  Universidade da Coruña

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: February 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (8)