About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 60 years or older;
diagnosis of MCI or dementia according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision).
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Cognitive Stimulation Therapy group
BehavioralThe CST group provides weekly mental stimulation activities on a specific topic as mentioned above. It consists of a total of 14 sessions with two sessions per week, each lasting approximately 45 minutes and led by an occupational therapist. CST group consists of 14 sessions, with each session focusing on a theme, including: reality orientation, childhood, physical games, food, sound, faces, number games, word association, word games, current events, categorizing objects, using money, being creative, and team games. The stimulating activities are designed to match the abilities and interests of participants. CST groups will be delivered by trained occupational therapists.
Calligraphy group
BehavioralThe Calligraphy group offers weekly calligraphy activities, comprising 14 sessions in total, with two sessions per week. Each session lasts approximately 45 minutes and is led by a rehabilitation assistant under the supervision of an occupational therapist.
Treatment groups
Trial outcomes
Primary outcomes
ADAS-Cog
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
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.
Secondary outcomes
Chinese Cornell Scale for Depression in Dementia (CSDD)
The Chinese Cornell Scale for Depression in Dementia (CSDD) is a 19-item scale for assessing the mood changes in older adults with dementia and MCI rated by the caregivers with satisfactory validity and internal consistency (Cronbach's α = 0.82; Lin et al., 2008). Each item (e.g., lack of reaction to pleasure) is rated using a 3-point scale: absent (0), mild or intermittent (1), and severe (2). The scores are summed across the items, with a total score ranging from 0 to 38. Higher scores indicate greater severity of depressive symptoms.
Chinese Quality of Life-Alzheimer's disease (QoL-AD)
The Chinese Quality of Life-Alzheimer's disease (QoL-AD) is a 13 item scale for assessing the QoL in older adults with dementia and MCI, with satisfactory validity and internal consistency (Cronbach's α = 0.78 to 0.92; Chan et al., 2009). In the present study, the QoL-AD scale is completed by both older adults with dementia and MCI as well as their caregivers independently to give self-rated and caregiver-rated QoL. Each item (e.g. "How do you feel about your physical health?") is rated on a 4-point scale (poor = 1, fair = 2, good = 3, excellent = 4). The scores are summed across the items, yielding a total score ranging from 13 to 52. Higher scores indicate better quality of life.
Engagement of a person with dementia scale (EPWDS)
The Engagement of a person with dementia scale (EPWDS) is a 10-item scale to assess five areas of engagement in in older adults with dementia and MCI, including affect, visual, verbal, behavioural and social, rated by the caregivers with satisfactory validity and good internal consistency (Cronbach's α = 0.94; Jones et al., 2018). Each item (e.g. displays positive affect such as pleasure, contentment or excitement) is rated on a 5-point Likert scale, with scores ranging from "1" (strongly agree) to "5" (strongly disagree). The scores are summed across the items, with a total score ranging from 10 to 50. Higher scores indicate a higher level of positive engagement.
The Chinese Social Functioning in Dementia scale (SF-DEM)
The Chinese Social Functioning in Dementia scale (SF-DEM) is a 17-item scale for assessing social interactions with family, friends, and the community in older adults with dementia and MCI, with acceptable validity and internal consistency (Cronbach's α = 0.60 to 0.64; Chan et al., 2009). In the present study, the SF-DEM is completed by both older adults with dementia and MCI as well as their caregivers independently to give self-rated and caregiver-rated social functioning. Each item (e.g. Asked other people about their feelings or concerns) is rated using a 4-point scale, ranging from "0" (never) to "3" (always). The scores are summed over the items, with a total score raning from 0 to 51. Higher scores indicate better social functioning.
Sponsors and contacts
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City University of Hong Kong
Lead sponsor
The Hong Kong Society for the Aged
Collaborator