L'Impatto Della Realtà Virtuale Nella Terapia Della Reminiscenza: Al di là Del Tempo, un Ponte Tra Passato e Presente Nel Paziente Anziano
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Global Cognitive Functioning Assessed With the MMSE-2
研究概览
简要总结
This study evaluated whether immersive virtual reality (VR) could enhance the effects of reminiscence therapy in older adults with cognitive impairment attending day-care services. Participants were assigned to one of three conditions: individual reminiscence therapy supported by immersive VR (RT+VR), individual traditional reminiscence therapy without VR, or usual care. The study examined changes in cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. The aim was to determine whether adding an immersive and personalized virtual environment to reminiscence therapy could provide additional benefits compared with traditional reminiscence therapy and usual care.
详细描述
This was a pragmatic, three-arm randomized interventional study conducted in two day-care centres for older adults in North-East Italy. The study investigated the effects of immersive virtual reality-assisted reminiscence therapy (RT+VR) in older adults with mild-to-moderate cognitive impairment.
Participants were randomly assigned to one of three conditions: (1) individual reminiscence therapy supported by immersive VR; (2) individual traditional reminiscence therapy without VR; or (3) usual care consisting of the routine activities provided by the day-care centres without structured reminiscence therapy or VR.
In the RT+VR condition, reminiscence therapy was supported by immersive environments presented through a head-mounted VR display. Virtual scenarios were used as contextual cues to facilitate the retrieval and narration of autobiographical memories. The traditional reminiscence therapy condition followed comparable therapeutic principles and was delivered individually without immersive technology, using conventional reminiscence materials and conversational prompts.
Outcomes were assessed at baseline and after completion of the intervention period. Assessments included measures of cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. Additional neuropsychological measures were used to assess selected cognitive functions. Outcome assessments were conducted by psychologists who were not involved in intervention delivery and were blinded to group allocation.
The study was designed to examine whether the addition of immersive VR to reminiscence therapy was associated with greater changes in psychological and cognitive outcomes than traditional reminiscence therapy and usual care.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessments were conducted by psychologists who were not involved in intervention delivery and were blinded to participants' group allocation.
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
- •Older adults attending one of the participating day-care centres.
- •Presence of mild-to-moderate cognitive impairment, as determined by the study's cognitive screening criteria.
- •Ability to participate in the study procedures and reminiscence therapy sessions.
- •Provision of written informed consent by the participant and/or, where required, by a legal representative.
排除标准
- •Severe or very severe cognitive impairment below the MMSE eligibility threshold.
- •Major visual impairment incompatible with the use of immersive virtual reality or study procedures.
- •Absence of informed consent from the participant and/or legal representative where required.
- •Clinical or functional conditions preventing safe participation in the intervention or completion of study procedures.
研究组 & 干预措施
VR-Assisted Reminiscence Therapy (RT+VR)
Participants received individual reminiscence therapy supported by immersive virtual reality. The intervention comprised 12 individual sessions, delivered twice weekly and lasting approximately 35 minutes each. Immersive virtual environments were used as contextual and autobiographical cues to facilitate reminiscence. Participants remained seated during VR exposure, and virtual scenarios were managed by an external operator to minimize cognitive and operational demands.
干预措施: Virtual Reality-Assisted Reminiscence Therapy (Behavioral)
Traditional Reminiscence Therapy (RT)
Participants received individual traditional reminiscence therapy without virtual reality. The intervention was dose-matched to the RT+VR condition, with 12 individual sessions delivered twice weekly and lasting approximately 35 minutes each. Reminiscence was facilitated using conventional autobiographical cues, including photographs, objects, and guided discussion of personal memories.
干预措施: Traditional Reminiscence Therapy (Behavioral)
Usual Care
Participants continued the routine activities provided by their day-care centre and did not receive structured reminiscence therapy or virtual reality as part of the study.
结局指标
主要结局
Change in Global Cognitive Functioning Assessed With the MMSE-2
时间窗: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Global cognitive functioning was assessed using the Mini-Mental State Examination, Second Edition (MMSE-2). Total scores were adjusted for age and/or educational level according to the correction procedures specified in the test manual. Higher scores indicate better global cognitive functioning. Change from baseline to post-intervention was compared across the three study groups.
Change in Depressive Symptoms Assessed With the Geriatric Depression Scale
时间窗: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Depressive symptoms were assessed using the Geriatric Depression Scale (GDS). Higher scores indicate greater depressive symptom severity. Change from baseline to post-intervention was compared across the three study groups.
Change in Neuropsychiatric Symptoms Assessed With the Neuropsychiatric Inventory
时间窗: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Neuropsychiatric symptoms were assessed using the Neuropsychiatric Inventory (NPI). Symptom severity was evaluated using frequency-by-severity scores (frequency × severity) for the assessed neuropsychiatric domains. NPI-derived symptom composite scores were also examined. Higher scores indicate greater neuropsychiatric symptom burden. Change from baseline to post-intervention was compared across the three study groups.
Change in Health-Related Quality of Life Assessed With the SF-36
时间窗: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36) across its health domains. For most domains, higher scores indicate better perceived health or functioning. Role Physical and Role Emotional were scored as limitation measures in this study, with higher scores indicating greater limitations. Change from baseline to post-intervention was compared across the three study groups.
次要结局
未报告次要终点
研究者
Davide Maria Marchioro
Head of the Psychology Area and Principal Investigator
Istituto Universitario Salesiano Venezia-Mestre (IUS)