Effectiveness of Cognitive Stimulation Therapy Group for Residential Home Residents With Dementia and Mild Cognitive Impairment-- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- ADAS-Cog
研究概览
简要总结
The research aims to investigate the effectiveness a cognitive stimulation therapy group for older adults with dementia and mild cognitive impairment living in residential homes.
This study adopts a multicenter randomized control trial two arms research design. The randomized controlled trial will compare a typical 14-session cognitive stimulation therapy group with a calligraphy group to determine whether the 14-session cognitive stimulation therapy group can produce better intervention outcomes for older adults with dementia and mild cognitive impairment, including cognitive functions, depressive symptoms, activities engagement, social functioning and, quality of life.
详细描述
Objective: The research aims to investigate the effectiveness CST group for residential home residents with dementia and MCI. Additionally, the underlying mechanism of change of CST group will also be investigated.
Hypotheses.
- The CST group is effective in improving cognitive abilities, depressive symptoms, engagement, social interaction and quality of life compared to the control group after the intervention.
- The positive intervention results of the CST group are maintained at the 3-month follow-up
- Improvement in cognitive ability is predicted by improved engagement in group activities.
Research Design. This study adopts a multicentre randomized control trial research design, involving 110 older people with dementia and MCI recruited from residential homes of SAGE. Using cluster randomization, participants will be openly recruited into activity groups in residential homes for older adults. The activity groups will then be randomly assigned to the intervention or control group in a 1:1 ratio. The intervention group will receive a 14-session CST group, while the control group will receive a calligraphy group. A research staff, who does not involve in the group allocation and group intervention, conduct the intervention outcomes assessment of the participants before and after the intervention and 3-months follow-up. Standardized assessment tools are used to assess the intervention outcomes, including cognitive functions, depression, quality of life, and engagement and social functioning. The ethical considerations of this study will be reviewed and approved by the Research Committee of the City University of Hong Kong. Data collection will begin in January 2026 and be completed in August 2026.
Subject Inclusion Criteria:
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
A research staff, who does not involve in the group allocation and delivery of group interventions, conduct the intervention outcomes assessment of the participants before and after the intervention and 3-months follow-up. Standardized assessment tools are used to assess the intervention outcomes, including cognitive functions, depression, quality of life, and engagement and social functioning
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60 years or older;
- •diagnosis of MCI or dementia according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision).
- •Remark: Participants who do not receive a diagnosis of MCI or dementia will undergo a screening assessment by a researcher using the Chinese Montreal Cognitive Assessment (MoCA)-5 minutes.
排除标准
- •Those who are unable to participate independently in group activities, who exhibit disruptive behavior and/or are severely impaired by physical disabilities (e.g. severe hearing and visual impairment) and physical illnesses (e.g. frequent hospital stays) are excluded.
研究组 & 干预措施
Cognitive stimulation therapy
In this study, the Cognitive Stimulation Therapy (CST) group follows the standard CST protocol of 14 sessions, with two sessions per week over a 7-week intervention period, as developed by Spector et al. (2003).
干预措施: Cognitive Stimulation Therapy group (Behavioral)
Control group
The control group participants will attend a calligraphy group consisting of 14 sessions, with two sessions per week. Each session will be led by a rehabilitation assistant under the supervision of an occupational therapist.
干预措施: Calligraphy group (Behavioral)
结局指标
主要结局
ADAS-Cog
时间窗: ADSA_cog will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
The ADAS-Cog has good validity and internal consistency (Cronbach's α = 0.9; Chu et al., 2000), and covers eleven cognitive tasks, including word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, language, comprehension of spoken language, and word finding difficulty. Total scores range from 0 to 70, with higher scores signify more severe cognitive impairment.
MoCA
时间窗: MoCA will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
The MoCA has satisfactory validity, internal consistency (Cronbach's α = 0.8; Yeung et al., 2014), and is widely used for screening and assessment of mild cognitive impiarment (Chen et al, 2021). It assesses global and specific cognitive abilities, including memory recall, attention, concentration, executive functions, language, visuospatial skills, abstract reasoning, calculation and orientation (Yeung et al., 2014). The scores are summed over the items, with a total score ranginge from 1 to 30. Higher scores indicate better cognitive abilities.
次要结局
- Chinese Cornell Scale for Depression in Dementia (CSDD)(CSDD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.)
- Chinese Quality of Life-Alzheimer's disease (QoL-AD)(QoL-AD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.)
- Engagement of a person with dementia scale (EPWDS)(EPWDS will be used before intervention, after 7 weeks intervention, and 3-month follow-up)
- The Chinese Social Functioning in Dementia scale (SF-DEM)(It will be used before the intervention, after 7-weeks intervention and 3-months follow-up.)
- Clinical Sustainability Assessment Tool (CSAT)(It will be used after 7-weeks intervention)
研究者
Daniel Young
Professor
City University of Hong Kong