Clinical trial NCT06812442: Effectiveness of a 3-month Individual Reminiscence Therapy Program in Older Adults With Alzheimer's Disease
Official title: Effectiveness of a 3-month Individual Reminiscence Therapy Program on Global Cognition, Mood, and Quality of Life in Older Adults With Mild to Moderate Alzheimer's Disease: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Cognitive Impairment
Keywords: older adults
reminiscence therapy
quality of life
mood
depression
anxiety
Alzheimer´s disease
non-pharmacological therapies
randomized controlled trial
Lead sponsor: Rsocialform - Geriatria, Lda
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 40
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 research aims to evaluate the effectiveness of individual Reminiscence Therapy (RT) program, using a simple reminiscence format, to improve the overall cognitive function, mood, and quality of life (QoL) of older adults with mild to moderate Alzheimer's disease attending social care and support services. A multicentre randomised controlled trial (RCT) is proposed in Portugal with repeated measures (pre-intervention, and post-intervention). 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: Alzheimer's disease (AD) is a genetic and sporadic neurodegenerative disease that is associated with a decline in cognitive function, memory, speech, and ultimately sensory and motor problems. The onset of these changes may be gradual or sudden. In people with mild Alzheimer's, symptoms such as learning and memory problems, poor judgment, mood swings, depression, and restlessness occur.

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 older adults with AD. 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 review by Woods et al. in 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 older adults 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 effectiveness of individual RT program within a general reminiscence format, to improve overall cognitive function, emotional state (depression and anxiety), and QoL of older adults with AD attending social care and support services in the Portugal.

It is proposed to evaluate the efficacy of the intervention in the endpoint assessment. 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 15 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 studies that used the same individual RT program and the same experimental design.

Eligibility criteria: Inclusion Criteria:

* 65 years or older.
* Receiving care and support services for at least three months.
* Diagnosis of probable Alzheimer's disease according to Diagnostic and Statistical Manual of Mental Disorders (DSM), fifth edition text revision criteria.
* Intact communication skills.
* Native Portuguese speaking.
* Signed informed consent by the participant.
* Mini Mental State Examination (MMSE) score between 10 and 24 points

Exclusion Criteria:

* Severe sensory and physical limitations.
* Acute or serious illness precluding participation in the RT sessions.
* Evidence of aggressive and disruptive behaviour, as observed by staff at the facility.
* Starting neuroleptics or antipsychotics within two months of recruitment.
* No literacy (educational level).

Primary outcomes:
measure: Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
timeFrame: baseline
measure: Change in cognitive functioning evaluated through MMSE
timeFrame: 13 weeks after the beginning of the intervention
Secondary outcomes:
measure: Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
timeFrame: baseline
measure: Change in mood assessed through the GDS-15
timeFrame: 13 weeks after the beginning of the intervention
measure: Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
timeFrame: baseline
measure: Change in anxiety symptomatology assessed through the GAI
timeFrame: 13 weeks after the beginning of the intervention
measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: baseline
measure: Change in quality of life evaluated through QoL-AD
timeFrame: 13 weeks after the beginning of the intervention
measure: Quality of life evaluated through dementia Quality of Life scale (DEMQoL)
timeFrame: baseline
measure: Change in quality of life evaluated through DEMQoL
timeFrame: 13 weeks after the beginning of the intervention
Other outcomes:
measure: Sociodemographic information gathered through the sociodemographic questionnaire
timeFrame: baseline
Locations:
city: Serpa
country: Portugal
facility: Centro Social e Paroquial de Brinches
state: Beja
city: Barcelos
country: Portugal
facility: Centro Social Remelhe D. António Barroso
state: Braga
city: Torres Vedras
country: Portugal
facility: Associação de Socorros da Freguesia Turcifal
state: Lisbon
city: Guarda
country: Portugal
facility: Fundação João Bento Raimundo
Study officials:
affiliation: Polytechnic University of Beja
name: Susana I. Justo Henriques, PhD
role: STUDY_DIRECTOR
affiliation: Polytechnic University of Beja
name: Célia C Silva, BsC
role: PRINCIPAL_INVESTIGATOR
References: