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临床试验/NCT06812442
NCT06812442已完成不适用

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

Rsocialform - Geriatria, Lda4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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).

研究组 & 干预措施

Intervention Group

Experimental

Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy (RT) or to a control group receiving only Treatment as Usual (TAU). Participants in the intervention group will participate in two RT sessions per week for 13 weeks besides their TAU. The sessions will be based on the Book of the Past and the Present and they will follow the same protocol in every participant site.

干预措施: Reminiscence therapy (Other)

Control Group

No Intervention

Participants assigned to the control group will maintain TAU in the site, participating in the activities previously assigned to their individual care plan.

结局指标

主要结局

Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)

时间窗: baseline

MMSE is a widely used screening tool that evaluates cognitive domains such as orientation, attention, memory, language, and visual-spatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning

Change in cognitive functioning evaluated through MMSE

时间窗: 13 weeks after the beginning of the intervention

Cognitive functioning is assessed using the MMSE is a widely used screening tool that evaluates global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

次要结局

  • Mood assessed through the Geriatric Depression Scale-15 (GDS-15)(baseline)
  • Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)(baseline)
  • Change in mood assessed through the GDS-15(13 weeks after the beginning of the intervention)
  • Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)(baseline)
  • Change in anxiety symptomatology assessed through the GAI(13 weeks after the beginning of the intervention)
  • Change in quality of life evaluated through QoL-AD(13 weeks after the beginning of the intervention)
  • Quality of life evaluated through dementia Quality of Life scale (DEMQoL)(baseline)
  • Change in quality of life evaluated through DEMQoL(13 weeks after the beginning of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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