Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Adherence
研究概览
简要总结
The aim of this pilot RCT is the development, implementation, and evaluation of a cognitive stimulation program with virtual reality for individuals aged 65 or older who have depressive symptoms and attend Portuguese day centers. The program aims to promote their cognitive functioning, well-being and functionality, and to reduce their depressive symptoms. A pilot study of the program will be conducted to assess its feasibility and preliminary efficacy.
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)
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
- •Individuals aged 65 years or older attending Portuguese day care centers;
- •Presence of mild, moderate, or severe depressive symptomatology;
- •Language skills and visual acuity.
排除标准
- •Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
结局指标
主要结局
Adherence
时间窗: Throughout the intervention period (6 weeks)
The proportion of participants who complete all intervention sessions. Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.
Acceptability and Feasibility
时间窗: Post-intervention (at week 7)
Acceptability and feasibility will be assessed through Theoretical Framework of Acceptability Questionnaire (TFA). All items are assessed on a 5-point Likert scale, with scores ranging from 1 to 5. Scores range from 7 to 35, with higher scores indicating better acceptability and feasibility.
Acceptability and perceived barriers (semi-strutured interviews)
时间窗: Post-intervention (at week 7)
Acceptability of the intervention will be assessed through semi-structured interviews conducted with each participant after the intervention. The interviews will explore participants' overall evaluation of the program, including its perceived relevance, satisfaction with the intervention, and willingness to continue or recommend it. Perceived barriers to implementation will also be explored by asking participants to describe any difficulties or challenges they experienced during their participation.
次要结局
- Depressive symptoms(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Well-being(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Functionality(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Global cognitive functioning(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Visual attention and processing speed(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Executive functioning and cognitive flexibility(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Frontal executive functioning(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Attention and immediate verbal memory(Baseline, post-intervention (at week 7) and follow-up (3 months))
- Working memory(Baseline, post-intervention (at week 7) and follow-up (3 months))
研究者
Sofia Borges de Sousa
PhD Student
Grupo Lusófona