DementiaNCT04658394
Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders
A study testing Reminiscence therapy in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 13 sites in Portugal.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Neurocognitive Disorders, Cognitive Impairment
- What is being tested?
- Reminiscence therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 13 sitesPortugal
- Study dates
- 11 Feb 2021to 31 Aug 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Portugal13 sites
Santa Casa da Misericórdia de Angra do Heroísmo
Angra do Heroísmo, Terceira, 9700-020
Casa do Povo de Arrifes
Arrifes, São Miguel, 9500-377
Santa Casa da Misericórdia da Calheta
Calheta, São Jorge, 9850-070
Santa Casa da Misericórdia da Horta
Horta, Faial, 9900-033
Santa Casa da Misericórdia de Lajes do Pico
Lajes, Pico, 9930-126
Santa Casa da Misericórdia da Madalena do Pico
Madalena, Pico, 9950-322
Casa do Povo da Maia
Maia, São Miguel, 9625-320
Rsocialform - Geriatria, Lda.
Mealhada, Aveiro District, 3050-387
Lar Luis Soares de Sousa de Ponta Delgada
Ponta Delgada, São Miguel
Lar D. Pedro V
Praia da Vitória, Terceira, 9760-438
Santa Casa da Misericórdia de Santa Cruz das Flores
Santa Cruz das Flores, Flores
Casa de Repouso João Inácio de Sousa
Velas, São Jorge, 9800-559
Santa Casa da Misericórdia de Vila do Porto
Vila do Porto, Santa Maria, 9580-528
About this study
Official title: Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders: A Multicentre Randomised Controlled Trial in Azores Archipelago
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.
Read the detailed 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).
- Conditions
- Dementia, Neurocognitive Disorders, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline
- Being tested
- Reminiscence therapy
- Keywords
- older adults, dementia, reminiscence therapy, quality of life, cognition, neurocognitive disorders, individual therapy, non-pharmacological therapy, randomised controlled trial, mood, depression, anxiety, memory
- Medical subject headings
- Dementia, Neurocognitive Disorders, Cognitive Dysfunction, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving RT or to a control group receiving treatment as usual. Participants in the intervention group will participate in two RT sessions per week for 13 weeks besides their treatment as usual. The sessions will be based on the Book of the Past and the Present and they will follow the same protocol in every participant institution. Receives: Other: Reminiscence therapy |
| Control Group | No intervention | Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
Secondary outcomes (15)
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
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.
Measured: baseline
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.
Measured: 13 weeks after the beginning of the intervention
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.
Measured: 12 weeks after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start11 Feb 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rsocialform - Geriatria, Lda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana I Justo Henriques, PhD, Principal investigator, Nursing School of CoimbraEnrique Pérez Sáez, PhD, Principal investigator, National Reference Centre for Alzheimer's and Dementia Care, Imserso, SpainJoão L. Alves Apóstolo, PhD, Principal investigator, Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658394
- Sponsor's protocol ID
- 21112020
- Status last verified
- Jan 2021
- First submitted
- 24 Nov 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21543189Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joel ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chene 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.
PubMed 26572551Apóstolo 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
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
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.
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. doi: 10.1016/j.rbp.2012.05.008.
PubMed 23429813Barrios H, Verdelho A, Narciso S, Goncalves-Pereira M, Logsdon R, de Mendonca 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.
PubMed 23534370Caddell 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.
PubMed 19896760Charlesworth 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.
PubMed 27521377Dempsey 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.
PubMed 24599812Folstein 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 1202204Freitas 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 25531579Gonzalez J, Mayordomo T, Torres M, Sales A, Melendez JC. Reminiscence and dementia: a therapeutic intervention. Int Psychogeriatr. 2015 Oct;27(10):1731-7. doi: 10.1017/S1041610215000344. Epub 2015 Mar 13.
PubMed 25765779Guerreiro 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.
PubMed 19595856
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders: A Multicentre Randomised Controlled Trial in Azores Archipelago
- ClinicalTrials.gov ID
- NCT04658394
- Acronym / sponsor ID
- 21112020
- Conditions
- Dementia, Neurocognitive Disorders, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline
- Keywords
- older adults, dementia, reminiscence therapy, quality of life, cognition, neurocognitive disorders, individual therapy, non-pharmacological therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Rsocialform - Geriatria, LdaUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Reminiscence therapyParticipants who meet the inclusion criteria will be randomly assigned to the intervention group receiving RT or to a control group receiving treatment as usual. Participants in the intervention group will participate in two RT sessions per week for 13 weeks besides their treatment as usual. The sessions will be based on the Book of the Past and the Present and they will follow the same protocol in every participant institution. |
| Control Group | No intervention | –Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminiscence therapyIntervention 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. | Other | Intervention Group |
Primary outcome
Cognitive functioning evaluated through Mini-Mental State Examination [MMSE]
Time frame: baseline
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.
Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]
Time frame: 13 weeks after the beginning of the intervention
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.
Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]
Time frame: 12 weeks after end of intervention
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.
15 secondary outcomes
Quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]
Time frame: baseline
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]
Time frame: 13 weeks after the beginning of the intervention
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]
Time frame: 12 weeks after end of intervention
Anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]
Time frame: baseline
Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]
Time frame: 13 weeks after the beginning of the intervention
Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]
Time frame: 12 weeks after end of intervention
Mood assessed through the Geriatric Depression Scale-15 [GDS-15]
Time frame: baseline
Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15]
Time frame: 13 weeks after the beginning of the intervention
Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15]
Time frame: 12 weeks after end of intervention
Executive functions evaluated throught Frontal Assessment Battery [FAB]
Time frame: baseline
Change in executive functions evaluated throught Frontal Assessment Battery [FAB]
Time frame: 13 weeks after the beginning of the intervention
Change in executive functions evaluated throught Frontal Assessment Battery [FAB]
Time frame: 12 weeks after end of intervention
Memory function evaluated through Memory Alteration Test [MAT]
Time frame: baseline
Change in memory function evaluated through Memory Alteration Test [MAT]
Time frame: 13 weeks after the beginning of the intervention
Change in memory function evaluated through Memory Alteration Test [MAT]
Time frame: 12 weeks after end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 21543189Akanuma 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.
- Background: PubMed 26572551Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joel ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chene 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.
- BackgroundApóstolo 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
- BackgroundApóstolo 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
- BackgroundAraújo 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.
- Background: PubMed 23429813Serrani 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. doi: 10.1016/j.rbp.2012.05.008.
- Background: PubMed 23534370Barrios H, Verdelho A, Narciso S, Goncalves-Pereira M, Logsdon R, de Mendonca 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.
- Background: PubMed 19896760Caddell 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.
- Background: PubMed 27521377Charlesworth 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.
- Background: PubMed 24599812Dempsey 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.
- Background: PubMed 1202204Folstein 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.
- Background: PubMed 25531579Freitas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana I Justo Henriques, PhD principal investigator
Nursing School of Coimbra
Enrique Pérez Sáez, PhD principal investigator
National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain
João L. Alves Apóstolo, PhD principal investigator
Nursing School of Coimbra
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence therapy in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 13 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 7 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 [MMSE] (time frame: baseline). The study lists 3 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 NCT04658394, which also lists 47 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 1 Sep 2021.