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Набира участници Не е приложимо NCT07372066

Cognitive Stimulation Therapy Group for Residential Home Residents With Dementia and Mild Cognitive Impairment

Не е приложима фаза (напр. обсервационно)
Заболявания: Cognitive Functions

Спонсор: City University of Hong Kong

Налично на: БГ
Обобщение
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.
Описание
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. 1. 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. 2. The positive intervention results of the CST group are maintained at the 3-month follow-up 3. 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: 1. age 60 years or older; 2. diagnosis of MCI or dementia according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision); 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. Subject Exclusion Criteria 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. Sample size estimation. The sample size of this study is estimated by using power analysis G\*Power 3.1. Recent studies on CST suggest a medium to large effect size on improving cognitive function. This study aims to detect a medium effect size (i.e., Cohen's d = 0.40) with a statistical power of 0.80 for all intervention outcomes and with a dropout rate of 20%, 110 people with dementia will be recruited in this study. Intervention and Control Group Activities. The participants are randomly assigned to an intervention group or a control group. The intervention group receives the Cognitive S
Кой може да участва
Inclusion Criteria: 1. age 60 years or older; 2. 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. Exclusion Criteria: 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.
Интервенции
Cognitive Stimulation Therapy group
BEHAVIORAL
Calligraphy group
BEHAVIORAL
Места на провеждане 1
Hong Kong (1)
SAGE Old Age Homes
Hong Kong , Hong Kong
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
60 Years
Здрави доброволци
Не
Начална дата
01.01.2026
Крайна дата
30.09.2026
Регистрационен номер
NCT07372066
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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