Clinical trial NCT04047238: Multicentre Study About the Effect of Individual Reminiscence Therapy
Official title: Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Cognitive Decline
Dementia
Neurocognitive Disorders
Keywords: Dementia
Cognitive Impairment
Cognitive Decline
Neurocognitive Disorders
Elderly
Reminiscence Therapy
Individual Intervention
Cognition
Depression
Quality of Life
Lead sponsor: Rsocialform - Geriatria, Lda
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 251
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive function, mood and quality of life (QoL) of elderly people with neurocognitive impairment attending social responses. It is proposed a multicenter study with an experimental design with randomized controlled repeated measures. Participants in the intervention group will hold two RT sessions per week for three months. Control group participants will maintain their treatment as usual.

Detailed description: Neurocognitive disorder is a major cause of disability among older people and its incidence is increasing due to an aging population. Neurocognitive disorders globally are estimated to affect 44.35 million people and it is expected that by the year 2050 the number of affected people globally will triple to 135.46 million.

The absence of effective pharmacological treatment that stops or slows down the development of the disease has aroused interest in non-pharmacological therapies as a complement to pharmacological treatment that may improve the quality of life of people with neurocognitive disorders. One of the most investigated and most traditional non-pharmacological therapy in this field is Reminiscence Therapy (RT).

RT involves discussing past activities, events and experiences, usually with the help of triggers, such as photographs, household objects and other familiar items from the past, music... that is, any object or stimulus that serves to stimulate remembrance. In its application to dementia, RT is based on the fact that the memory impairment of people with dementia means that they are able to recall events from their past life, especially from childhood to early adulthood, but cannot remember more recent facts. It focuses on preserved memories and abilities, promotes communication, and enables the person to connect with his/her past and regain his/her sense of personal identity. Thus, RT can be understood as an intervention on the edge of those of cognitive orientation and emotion-centered, with potential interactive effects on autobiographical memory and psychological well-being.

The investigators can distinguish at least two RT approaches. The first one is the "life review" where participants are guided through meaningful experiences from their biography trying to make sense of their life. This type of RT is more structured and is usually conducted in an individual format. It may imply the construction of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with the person's past. Another approach is the simple reminiscence which involves the stimulation of autobiographical memory during conversations about specific themes of the past (such as holidays, food and drinks, work...) using stimuli that trigger memories. It has been described as an unstructured narrative of autobiographical memories. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.

In any of the TR formats it is essential to introduce triggering stimuli (photographs, music, antique objects...) to aid in recall. These triggers may be generic, reflecting common experiences in the lives of people relevant to their age group (for example a textbook may serve to recall the experience during their school stage), or specific, with stimuli related to the individual's own experiences (for example photographs of an important life event such as your wedding day or a trip during your youth).

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

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

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

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

Finally, despite evidence of the effect of RT on mood of older people without dementia, in the case of people with dementia only a small effect on mood was found for those participants. in individual RT.

Therefore, this research proposal aims to evaluate the ability of individual RT using a simple reminiscence format to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorder attending social responses for the elderly.

Eligibility criteria: Inclusion Criteria:

* Having a diagnostic of a neurocognitive disorder according to the DSM-5 criteria.
* To have delivered the informed consent of the project, duly completed and signed, after prior information
* Capacity to communicate and understand.
* Possibility of gathering information about the participant's life history through their relatives or habitual caregivers, using the socio-familiar questionnaire design for that purpose.
* Being 65 years of age or older.
* Being a native Portuguese speaker.
* Regularly attend a social response institution that provides services for the elderly.

Exclusion Criteria:

* To suffer from an acute or severe illness that makes it impossible for them to participate in the intervention sessions.
* Serious sensory and physical limitations that prevent the participation in the sessions.
* Severe disconnection with the environment and very limited attention span.
* Presence of severe neuropsychiatric symptoms, such as hyperactivity, psychosis, severe depressive and anxiety symptoms and apathy, that prevent participation in the sessions or presence of uncontrolled delirium.
* Traumatic life history or marked by negative events relevant to the person that discourage the participation in the Reminiscence Therapy sessions.
* History of negative reactions during previous Reminiscence Therapy sessions or similar activities.

Primary outcomes:
measure: Cognitive functioning evaluated through Mini-Mental State Examination
timeFrame: Pre and post-intervention (3 months)
Secondary outcomes:
measure: Memory funtion evaluated through Memory Alteration Test
timeFrame: Pre and post-intervention (3 months)
measure: Executive functions evaluated through Frontal Assessment Battery
timeFrame: Pre and post-intervention (3 months)
measure: Mood evaluated through Geriatric Depression Scale -15
timeFrame: Pre and post-intervention (3 months)
measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease
timeFrame: Pre and post-intervention (3 months)
Other outcomes:
Locations:
city: Albergaria-a-Velha
country: Portugal
facility: Cediara - Assoc. Sol. Social de Ribeira de Fráguas
state: Aveiro
city: Mealhada
country: Portugal
facility: Rsocialform - Geriatria, Lda.
state: Aveiro
city: Ovar
country: Portugal
facility: Santa Casa Da Misericórdia de Ovar
state: Aveiro
city: Praia da Vitória
country: Portugal
facility: Lar D. Pedro V
state: Açores
city: Portimão
country: Portugal
facility: Delicate Age Lda.
state: Faro
city: Elvas
country: Portugal
facility: APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica
state: Portalegre
city: Almada
country: Portugal
facility: Santa Casa Da Misericordia de Almada - Centro São Lázaro
state: Setúbal
city: Braga
country: Portugal
facility: Centro Social Vale Do Homem
city: Braga
country: Portugal
facility: Santa Casa Da Misericórdia de Vila Verde
city: Braga
country: Portugal
facility: Centro Zulmira Pereira Simões
city: Castelo Branco
country: Portugal
facility: Santa Casa Da Misericórdia de Castelo Branco
city: Castelo Branco
country: Portugal
facility: Santa Casa Da Misericórdia de Vila Velha de Ródão
city: Guarda
country: Portugal
facility: Centro Social Paroquial Dornelas
city: Leiria
country: Portugal
facility: Primavida Residência Sénior Amor
city: Leiria
country: Portugal
facility: Santa Casa Da Misericórdia de Alcobaça
city: Leiria
country: Portugal
facility: Santa Casa Da Misericórdia Do Alvorge
city: Lisboa
country: Portugal
facility: Associação Alzheimer Portugal
city: Lisboa
country: Portugal
facility: Irmãs Hospitaleiras - Casa de Saúde Da Idanha
city: Portalegre
country: Portugal
facility: Centro Social de Tolosa
city: Porto
country: Portugal
facility: Centro Social Paroquial Recarei
city: Porto
country: Portugal
facility: Associação de Solidariedade Social S. Tiago de Rebordões
city: Santarém
country: Portugal
facility: Santa Casa Da Misericordia de Coruche
city: Viana Do Castelo
country: Portugal
facility: Santa Casa Da Misericórdia de Melgaço
city: Viseu
country: Portugal
facility: Santa Casa Da Misericórdia de Vouzela
city: Viseu
country: Portugal
facility: Pesqueiramiga- Associação de Solidariedade Social
Study officials:
affiliation: Cediara and University of de Santiago de Compostela
name: Susana I Justo Henriques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRE Alzheimer and University of Salamanca
name: Enrique Pérez Sáez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nursing School of Coimbra
name: João L Alves Apóstolo, PhD
role: PRINCIPAL_INVESTIGATOR
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