Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders

Dementia Clinical Trial

Official title:

Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders: A Multicentre Randomised Controlled Trial in Azores Archipelago

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658394
• Other study ID #: 21112020
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2021
• Source: Rsocialform - Geriatria, Lda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research aims to evaluate the ability of individual reminiscence therapy (RT), using a simple reminiscence format, to improve the overall cognitive function, memory, emotional status and quality of life (QoL) of older adults with neurocognitive disorders (NCD) attending social care and support services. A multicentre randomised controlled trial (RCT) is proposed in Azores archipelago with repeated measures (pre-intervention, post-intervention and follow-up). Intervention group will hold 26 individual RT sessions, twice a week for 13 weeks. Control group participants will maintain their treatment as usual. Make a subsample analysis of the main clinical diagnoses, and compare the results of sample and subsample with a previous study that had the same intervention protocol.

Description:

Neurocognitive disorder (NCD) is one of the main causes of disability among older adults and its prevalence is increasing due to the ageing of the population. It is estimated that globally, neurocognitive disorders affect 44.35 million people and it is expected that by the year 2050 the number of those affected worldwide will triple up to 135.46 million.

The absence of an effective pharmacological treatment that halts or delays the development of the disease has aroused interest in non-pharmacological therapies (NPT) as a complement to pharmacological treatment that can improve the quality of life of people with neurocognitive disorders. One of the most researched NPT and with the greatest tradition in this field is Reminiscence Therapy (RT).

RT implies the discussion of past activities, events and experiences, usually with the help of triggers (e.g., photographs, home objects and other familiar items from the past, music, any object or stimulus) that serve to stimulate memories. In its application to dementias, RT is based on the fact that the memory deficit of people with dementia implies that they are able to remember events from their past life, especially from childhood to early adulthood, but not newer facts. It focuses on preserved capacities and memories, promotes communication and enables the person to connect with his past and recover his sense of personal identity. In this way, the RT can be understood as an intervention on the edge of those of cognitive orientation and those centred on emotion, with potential interactive effects on autobiographical memory and psychological well-being.

In simplified form, there are at least two approaches to RT. The first approach as a "life review" where participants are guided through significant experiences of their biography trying to give meaning to their lives. This type of RT is more structured and is usually conducted in an individual format. It may involve the production of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with one's past. Another approach that call general or simple reminiscence, implies the stimulation of autobiographical memory during conversations on specific themes of the past (e.g, holidays, food and drink, work) using stimulus to trigger memories. It has been described as an unstructured autobiographical memory narration. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.

In either format that RT is applied on, the introduction of triggering stimulus (e.g., photographs, music, old objects) to help memory is considered fundamental. These triggers can be generic, reflecting common experiences in the lives of people relevant to their age group (e.g., a school manual can serve as a reminder of the experience during their school stage), or specific, with stimulus related to the person's own experiences (e.g., photographs of an important vital event such as their wedding day or a journey during their youth).

As for the effectiveness of RT, according to a recent review by Cochrane, there is some evidence on its positive effects on cognition, QoL, communication and possibly on the mood of people with dementia, even if the benefits are small. Despite the distinction between the two different approaches to RT (general reminiscence vs. life history), the therapy modality does not seem to be as important to achieve positive effects as the individual or group format of the sessions and the context in which the intervention is administered (people living in the community or institutionalised).

In particular, according to the results of the review study, the RT seems to be able to generate a small benefit on cognitive function immediately after the intervention, although it usually does not continue after a longer follow-up period. Regarding the administration format, the individual RT seems slightly superior in its effects on cognition both immediately and after a follow-up period. In any case, its effects seem comparable to those of other cognitive stimulation modalities.

As for the effect of RT on quality of life (QoL), an individual RT study based on life review, showed an improvement in Qol-AD. The effects with a group modality do not seem consistent, showing little or no effect on QoL, although the key factor may be the context of application (community vs. institution), with better group RT results in institutionalised patients.

In a multicentre study conducted in Portugal with older adults with neurocognitive disorders, in individual format, there was a significant effect on the overall cognition, memory and QoL of the participants.

Group RT was associated with a likely effect on communication both after the intervention and in the follow-up. This effect was not replicated in the individual RT, with uncertain results.

Finally, despite the evidence on the effect of RT on the mood of elderly people without dementia, in the case of people with dementia only a small effect on mood was found for those participating in individual RT. In the portuguese multicentre studies there were no significant differences in depressive symptomatology.

Based on the above, this research proposal aims to evaluate the ability of individual RT within a general reminiscence format, to improve overall cognitive function, in particular memory, emotional state (depression and anxiety) and QoL of older adults with neurocognitive disorders attending social care and support services in the Azores archipelago.

It is proposed to evaluate the efficacy of the intervention in the endpoint assessment and the duration of the effects at three months follow-up. Furthermore, an analysis of results based on the diagnosis of the participants is proposed for those diagnoses with sufficient representation in the sample (more than 20 cases in each group). Additionally, it is proposed to analyze the factors that predict the response to the intervention (responder analysis). Finally, the results of this study will be compared and can be analyzed together with those of a previous study that used the same individual RT program and the same experimental design (clinicaltrials.gov ID: NCT04047238).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Having a formal diagnosis of a neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM-5] criteria (participants diagnosis will be confirm in their health records at the institution).

• Having delivered the informed consent form, duly completed and signed, after prior information.

• Being able to communicate and understand.

• Possibility of gathering information about the participant's life history through family members or usual caregivers, using the socio-family questionnaire designed for that purpose.

• Being 65 years of age or older.

• Being a native Portuguese speaker.

• Regularly attending an institution that provides social care and support services for older adults (including people living in long-term care centres, people attending day and social centres and people receiving home support services).

Exclusion Criteria:

• Suffering from an acute or severe illness that prevent participation in the intervention sessions.

• Severe sensory and physical limitations that prevent participation.

• Low level of consciousness and minimal attention span.

• Presence of severe neuropsychiatric symptoms, such as agitation, psychosis, severe depressive and anxiety symptoms, apathy, or presence of uncontrolled delirium that prevent participation in the sessions.

• Traumatic life history or marked by adverse events that discourage participation in RT sessions; history of adverse reactions during RT sessions or similar activities.

• Have a serious or total functional dependence (assessed through the Barthel index).

Related Conditions & MeSH terms

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

Intervention

Other:
• Reminiscence therapy
Intervention group will receive two RT sessions per week for 13 weeks. RT sessions will last approximately 50 minutes and will be developed according to the following structure: · Welcome to the patient and reality orientation therapy (7 minutes) · Conducting the main activity of reminiscence (40 minutes) · Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of RT. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of the Past and the Present.

Locations

Country	Name	City	State
Portugal	Santa Casa da Misericórdia de Angra do Heroísmo	Angra Do Heroísmo	Terceira
Portugal	Casa do Povo de Arrifes	Arrifes	São Miguel
Portugal	Santa Casa da Misericórdia da Calheta	Calheta	São Jorge
Portugal	Santa Casa da Misericórdia da Horta	Horta	Faial
Portugal	Santa Casa da Misericórdia de Lajes do Pico	Lajes	Pico
Portugal	Santa Casa da Misericórdia da Madalena do Pico	Madalena	Pico
Portugal	Casa do Povo da Maia	Maia	São Miguel
Portugal	Rsocialform - Geriatria, Lda.	Mealhada	Aveiro
Portugal	Lar Luis Soares de Sousa de Ponta Delgada	Ponta Delgada	São Miguel
Portugal	Lar D. Pedro V	Praia Da Vitória	Terceira
Portugal	Santa Casa da Misericórdia de Santa Cruz das Flores	Santa Cruz das Flores	Flores
Portugal	Casa de Repouso João Inácio de Sousa	Velas	São Jorge
Portugal	Santa Casa da Misericórdia de Vila do Porto	Vila do Porto	Santa Maria

Sponsors (1)

Lead Sponsor	Collaborator
Rsocialform - Geriatria, Lda

Country where clinical trial is conducted

Portugal, 

References & Publications (47)

Akanuma K, Meguro K, Meguro M, Sasaki E, Chiba K, Ishii H, Tanaka N. Improved social interaction and increased anterior cingulate metabolism after group reminiscence with reality orientation approach for vascular dementia. Psychiatry Res. 2011 Jun 30;192(3):183-7. doi: 10.1016/j.pscychresns.2010.11.012. Epub 2011 May 4. — View Citation

Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joël ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chêne G, Dartigues JF. Group and individual cognitive therapies in Alzheimer's disease: the ETNA3 randomized trial. Int Psychogeriatr. 2016 May;28(5):707-17. doi: 10.1017/S1041610215001830. Epub 2015 Nov 17. — View Citation

Apóstolo J, Loureiro L, Reis I, Silva I, Cardoso D, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência. 2014; IV(3): 65-73. 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. 2018; 23: 99-107. doi: 10.5944/rppc.vol.23.num.2.2018.21050

Araújo F, Pais-Ribeiro J, Oliveira A, Pinto C. Validação do índice de Barthel numa amostra de idosos não institucionalizados. Revista Portuguesa de Saúde Pública. 2007; 25(2): 59-66.

Bárrios H, Verdelho A, Narciso S, Gonçalves-Pereira M, Logsdon R, de Mendonça A. Quality of life in patients with cognitive impairment: validation of the Quality of Life-Alzheimer's Disease scale in Portugal. Int Psychogeriatr. 2013 Jul;25(7):1085-96. doi: 10.1017/S1041610213000379. Epub 2013 Mar 27. — View Citation

Caddell LS, Clare L. The impact of dementia on self and identity: a systematic review. Clin Psychol Rev. 2010 Feb;30(1):113-26. doi: 10.1016/j.cpr.2009.10.003. Review. — View Citation

Charlesworth G, Burnell K, Crellin N, Hoare Z, Hoe J, Knapp M, Russell I, Wenborn J, Woods B, Orrell M. Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial. J Neurol Neurosurg Psychiatry. 2016 Nov;87(11):1218-1228. doi: 10.1136/jnnp-2016-313736. Epub 2016 Aug 12. — View Citation

Dempsey L, Murphy K, Cooney A, Casey D, O'Shea E, Devane D, Jordan F, Hunter A. Reminiscence in dementia: a concept analysis. Dementia (London). 2014 Mar 1;13(2):176-92. doi: 10.1177/1471301212456277. Epub 2012 Aug 17. — View 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. — View 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. — View Citation

Freitas S, Simões 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. — View Citation

Gonzalez J, Mayordomo T, Torres M, Sales A, Meléndez JC. Reminiscence and dementia: a therapeutic intervention. Int Psychogeriatr. 2015 Oct;27(10):1731-7. doi: 10.1017/S1041610215000344. Epub 2015 Mar 13. — View 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. 1994; 1: 9-10.

Haight BK, Gibson F, Michel Y. The Northern Ireland life review/life storybook project for people with dementia. Alzheimers Dement. 2006 Jan;2(1):56-8. doi: 10.1016/j.jalz.2005.12.003. — View Citation

Henriques SIJ. Livro do Passado e do Presente [Book of the Past and the Present]. Mealhada, Replicar Socialform; 2018.

Justo-Henriques SI, Pérez-Sáez E, Alves Apóstolo JL. Multicentre randomised controlled trial about the effect of individual reminiscence therapy in older adults with neurocognitive disorders. Int J Geriatr Psychiatry. 2021 May;36(5):704-712. doi: 10.1002/gps.5469. Epub 2020 Nov 17. — View Citation

Justo-Henriques SI, Pérez-Sáez E, Apóstolo JLA. Individual intervention protocol based on reminiscence therapy for older people with neurocognitive disorders. Revista de Enfermagem de Referência. 2020; 5(3): e20043. doi: 10.12707/RV20043

Kirk M, Berntsen D. A short cut to the past: Cueing via concrete objects improves autobiographical memory retrieval in Alzheimer's disease patients. Neuropsychologia. 2018 Feb;110:113-122. doi: 10.1016/j.neuropsychologia.2017.06.034. Epub 2017 Jul 1. — View Citation

Kirk M, Rasmussen KW, Overgaard SB, Berntsen D. Five weeks of immersive reminiscence therapy improves autobiographical memory in Alzheimer's disease. Memory. 2019 Apr;27(4):441-454. doi: 10.1080/09658211.2018.1515960. Epub 2018 Sep 8. — View Citation

Lai CK, Chi I, Kayser-Jones J. A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia. Int Psychogeriatr. 2004 Mar;16(1):33-49. — View 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. — View Citation

Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Aging. 1999; 5: 21-32.

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Dröes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850. — View Citation

Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental State Examination. Sinapse. 2009; 2: 10-16.

O'Shea E, Devane D, Cooney A, Casey D, Jordan F, Hunter A, Murphy E, Newell J, Connolly S, Murphy K. The impact of reminiscence on the quality of life of residents with dementia in long-stay care. Int J Geriatr Psychiatry. 2014 Oct;29(10):1062-70. doi: 10.1002/gps.4099. Epub 2014 Mar 14. — View Citation

Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 2007 Feb;19(1):103-14. — View Citation

Pérez-Sáez E, Justo-Henriques SI, Alves Apóstolo JL. Multicenter randomized controlled trial of the effects of individual reminiscence therapy on cognition, depression and quality of life: Analysis of a sample of older adults with Alzheimer's disease and vascular dementia. Clin Neuropsychol. 2021 Jan 19:1-22. doi: 10.1080/13854046.2021.1871962. [Epub ahead of print] — View Citation

Pinquart M, Duberstein PR, Lyness JM. Effects of psychotherapy and other behavioral interventions on clinically depressed older adults: a meta-analysis. Aging Ment Health. 2007 Nov;11(6):645-57. — View Citation

Prince M, Guerchet M, Prina M. World Alzheimer Report 2015. The global impact of dementia: An analysis of prevalence, incidence, cost and trends. London: Alzheimer´s Disease International (ADI); 2015. http://www.worldalzreport2015.org/downloads/world-alzheimer-report-2015.pdf

Rami L, Molinuevo JL, Sanchez-Valle R, Bosch B, Villar A. Screening for amnestic mild cognitive impairment and early Alzheimer's disease with M@T (Memory Alteration Test) in the primary care population. Int J Geriatr Psychiatry. 2007 Apr;22(4):294-304. — View Citation

Ribeiro O, Paúl C, Simões MR, Firmino H. Portuguese version of the Geriatric Anxiety Inventory: transcultural adaptation and psychometric validation. Aging Ment Health. 2011 Aug;15(6):742-8. doi: 10.1080/13607863.2011.562177. Epub 2011 Jun 9. — View Citation

Särkämö T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5. — View Citation

Serrani Azcurra DJ. A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial. Braz J Psychiatry. 2012 Dec;34(4):422-33. — View Citation

Subramaniam P, Woods B, Whitaker C. Life review and life story books for people with mild to moderate dementia: a randomised controlled trial. Aging Ment Health. 2014;18(3):363-75. doi: 10.1080/13607863.2013.837144. Epub 2013 Sep 24. — View Citation

Subramaniam P, Woods B. The impact of individual reminiscence therapy for people with dementia: systematic review. Expert Rev Neurother. 2012 May;12(5):545-55. doi: 10.1586/ern.12.35. Review. — View Citation

Subramaniam P, Woods B. Towards the therapeutic use of information and communication technology in reminiscence work for people with dementia: a systematic review. International Journal of Computers in Healthcare. 2010; 1: 106-125. doi: 10.1504/IJCIH.2010.037457.

Tadaka E, Kanagawa K. Effects of reminiscence group in elderly people with Alzheimer disease and vascular dementia in a community setting. Geriatrics & Gerontology International. 2007; 7: 167-173. doi: 10.1111/j.1447-0594.2007.00381.x

Thorgrimsen L, Schweitzer P, Orrell M. Evaluating reminiscence for people with dementia: A pilot study. The Arts in Psychotherapy. 2002; 29: 93-97. doi: 10.1016/S0197-4556(01)00135-6

Westerhof GJ, Bohlmeijer E, Webster JD. Reminiscence and mental health: A review of recent progress in theory, research and interventions. Ageing & Society. 2010; 30: 697-721. doi: 10.1017/S0144686X09990328

Wong PT, Watt LM. What types of reminiscence are associated with successful aging? Psychol Aging. 1991 Jun;6(2):272-9. — View Citation

Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3:CD001120. doi: 10.1002/14651858.CD001120.pub3. Review. — View Citation

Woods B, Spector A, Jones C, Orrell M, Davies S. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001120. Review. Update in: Cochrane Database Syst Rev. 2018 Mar 01;3:CD001120. — View Citation

Woods RT, Bruce E, Edwards RT, Elvish R, Hoare Z, Hounsome B, Keady J, Moniz-Cook ED, Orgeta V, Orrell M, Rees J, Russell IT. REMCARE: reminiscence groups for people with dementia and their family caregivers - effectiveness and cost-effectiveness pragmatic multicentre randomised trial. Health Technol Assess. 2012;16(48):v-xv, 1-116. doi: 10.3310/hta16480. — View Citation

Woods RT, Bruce E, Edwards RT, Hounsome B, Keady J, Moniz-Cook ED, Orrell M, Russell IT. Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol. Trials. 2009 Jul 30;10:64. doi: 10.1186/1745-6215-10-64. — View Citation

Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. — View Citation

* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic information gathered through the sociodemographic questionnaire	Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, formal education, which social response the participant attends, medical comorbidities and cognitive symptoms and will be administered to all participants.	baseline
Other	Functional dependence evaluated through Barthel Index [IB]	This is a 10-item self-administered scale that evaluates the functional capacity to conduct daily life activities. The activities are quoted differently, 0, 1, 2 or 3 points can be assigned. The total score ranges from 0 (totally dependent) to 20 (totally independent), with a total of 0-8 being total dependency; 9-12 being serious dependency; 13-19 being moderate dependency; 20 being total independence. This instrument has item-total correlations between .66 and .93, and has a high internal consistency (Cronbach alpha of .96).	before baseline (exclusion criteria)
Primary	Cognitive functioning evaluated through Mini-Mental State Examination [MMSE]	Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	baseline
Primary	Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]	Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	13 weeks after the beginning of the intervention
Primary	Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]	Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	12 weeks after end of intervention
Secondary	Quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.	baseline
Secondary	Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.	13 weeks after the beginning of the intervention
Secondary	Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.	12 weeks after end of intervention
Secondary	Anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]	It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.	baseline
Secondary	Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]	It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.	13 weeks after the beginning of the intervention
Secondary	Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]	It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.	12 weeks after end of intervention
Secondary	Mood assessed through the Geriatric Depression Scale-15 [GDS-15]	The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.	baseline
Secondary	Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15]	The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.	13 weeks after the beginning of the intervention
Secondary	Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15]	The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.	12 weeks after end of intervention
Secondary	Executive functions evaluated throught Frontal Assessment Battery [FAB]	The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.	baseline
Secondary	Change in executive functions evaluated throught Frontal Assessment Battery [FAB]	The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.	13 weeks after the beginning of the intervention
Secondary	Change in executive functions evaluated throught Frontal Assessment Battery [FAB]	The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.	12 weeks after end of intervention
Secondary	Memory function evaluated through Memory Alteration Test [MAT]	The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.	baseline
Secondary	Change in memory function evaluated through Memory Alteration Test [MAT]	The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.	13 weeks after the beginning of the intervention
Secondary	Change in memory function evaluated through Memory Alteration Test [MAT]	The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.	12 weeks after end of intervention