Cognitive FunctionsCSTSAGENCT07372066
Cognitive Stimulation Therapy Group for Residential Home Residents With Dementia and Mild Cognitive Impairment
A study testing Cognitive Stimulation Therapy group and Calligraphy group in people with Cognitive Functions, run by City University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Functions
- What is being tested?
- Cognitive Stimulation Therapy group and Calligraphy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
SAGE Old Age Homes
Hong Kong, Hong Kong
Ka Hei Christy Tang, Degree, +852 2871 8664, christy.tang@SAGE.ORG.HK
About this study
Official title: Effectiveness of Cognitive Stimulation Therapy Group for Residential Home Residents With Dementia and Mild Cognitive Impairment-- A Randomized Controlled 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.
Read the detailed description
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:
- age 60 years or older;
- 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 Simulation Therapy (CST) group, while the control group receives the calligraphy group.
The 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.
The Calligraphy group provides weekly calligraphy activities. It consists of a total of 14 sessions with two sessions per week, each lasting approximately 45 minutes and led by a rehabilitation assistant under the supervision of an occupational therapist.
Outcomes Assessment Tools The primary intervention outcome of this study is the improvement of cognitive ability as measured by the Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Chinese Montreal Cognitive Assessment (MoCA), which have been used as outcome assessment in previous studies of Chinese older adults with MCI.
The secondary intervention outcomes of this study are the improvement in depressive symptoms, engagement, social interaction and quality of life which are assessed by the following standardized scales.
- 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.
- The Chinese Quality of Life-Alzheimer's disease (QoL-AD) is a 13item scale for assessing the QoL in older adults with dementia and MCI. In this study, QoL-AD is completed by both older adults with dementia and MCI as well as their caregivers independently to give self-rated and caregiver-rated QoL.
- 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.
- The Chinese Social Functioning in Dementia scale (SF-DEM) is a 20-item scale for assessing social interactions with family, friends, and the community in older adults with dementia and MCI. 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.
- The Clinical Sustainability Assessment Tool (CSAT) is a 35-item scale for assessing the sustainability of clinical practices for the intervention group. This scale is rated by management and professional staff of SAGE residential homes.
Data Analyses. The analysis is carried out according to the intent-to-treat principle, whereby the multiple imputation method is used for missing data. The data analyses are performed with SPSS 29.0. Within-group intervention effects will be analyzed for all intervention groups using repeated measures one-way analysis of variance (ANOVA). Between group intervention effects are analyzed using 2 (group) x 2 (time) repeated measures of ANOVA. Within and between group effect sizes are computed using Cohen's d, with values of 0.2, 0.5, and 0.8 considered as small, medium, and large respectively.
Fidelity of intervention. Standardized program manuals for CST group and calligraphy group will be designed by the research team to suit the needs and interests of participants with dementia and MCI. The occupational therapists conducting the CST group have completed training on conducting CST group. In addition, they receive the standardized program manuals, training and regular supervision, as well as a surprise check from the research team when conducting the CST group to ensure that the interventions implemented by the occupational therapists meet the guidelines and skills of the standardized program manuals. The rehabilitation assistant conducting the calligraphy group will receive the standardized program manuals, training and regular supervision by an occupational therapist to ensure that the interventions conducted by rehabilitation assistant meet the guidelines and skills of the standardized program manuals.
Ethical Considerations. The ethical aspects of this study were reviewed and approved by the Research Committee of the City University of Hong Kong [Reference No.: HU-STA-00001945]. Written informed consent will be obtained from all participants and their guardians on the day of the screening before participants start receiving the intervention.
- Conditions
- Cognitive Functions
- Being tested
- Cognitive Stimulation Therapy group, Calligraphy group
- Keywords
- Cognitive Stimulation Therapy, Calligraphy group, Randomized Controlled trial, Mild cognitive impairment, Dementia
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation Therapy groupBehavioural
The 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 groupBehavioural
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive stimulation therapy | Active comparator | 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). Receives: Behavioral: Cognitive Stimulation Therapy group |
| Control group | Other | 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. Receives: Behavioral: Calligraphy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ADSA_cog will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
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.
Measured: MoCA will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
Secondary outcomes (5)
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.
Measured: CSDD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
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.
Measured: QoL-AD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
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.
Measured: EPWDS will be used before intervention, after 7 weeks intervention, and 3-month follow-up
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.
Measured: It will be used before the intervention, after 7-weeks intervention and 3-months follow-up.
Clinical Sustainability Assessment Tool (CSAT)
The Clinical Sustainability Assessment Tool (CSAT) is a 35-item scale for assessing the sustainability of clinical practices for the intervention group, with acceptable validity and internal consistency (Cronbach's α = 0.91; Malone et al., 2021). This scale is rated by management and professional staff of SAGE residential homes. CAST assesses seven domains, including engaged staff and leadership, engaged stakeholders, organisational readiness, workflow integration, implementation and training, monitoring and evaluation, and outcomes and effectiveness. Each domain consists of five items. Each item is rated using a 7-point Likert scale, ranging from "1" (none) to "7" (highest). The scores for each domain are summed across the items, with a total score ranging from 1 to 35. Higher scores indicate greater capacity and sustainability.
Measured: It will be used after 7-weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a multicentre randomized control trial two arms research design. The Cognitive Stimulation Therapy (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. CST group will be delivered by trained occupational therapists. The Calligraphy group provides weekly calligraphy activities. It consists of a total of 14 sessions with two sessions per week, each lasting approximately 45 minutes and led by a rehabilitation assistant under the supervision of an occupational therapist.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Society for the Aged
- Responsible party
- Principal investigator, Daniel Young, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372066
- Sponsor's protocol ID
- HU-STA-00001945
- Acronym
- CSTSAGE
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Woods B, Rai HK, Elliott E, Aguirre E, Orrell M, Spector A. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2023 Jan 31;1(1):CD005562. doi: 10.1002/14651858.CD005562.pub3.
PubMed 39804128Wong A, Yiu S, Nasreddine Z, Leung KT, Lau A, Soo YOY, Wong LK, Mok V. Validity and reliability of two alternate versions of the Montreal Cognitive Assessment (Hong Kong version) for screening of Mild Neurocognitive Disorder. PLoS One. 2018 May 23;13(5):e0196344. doi: 10.1371/journal.pone.0196344. eCollection 2018.
PubMed 29791452Thorgrimsen L, Selwood A, Spector A, Royan L, de Madariaga Lopez M, Woods RT, Orrell M. Whose quality of life is it anyway? The validity and reliability of the Quality of Life-Alzheimer's Disease (QoL-AD) scale. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):201-8. doi: 10.1097/00002093-200310000-00002.
PubMed 14657783Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
PubMed 12948999Malone S, Prewitt K, Hackett R, Lin JC, McKay V, Walsh-Bailey C, Luke DA. The Clinical Sustainability Assessment Tool: measuring organizational capacity to promote sustainability in healthcare. Implement Sci Commun. 2021 Jul 17;2(1):77. doi: 10.1186/s43058-021-00181-2.
PubMed 34274004Gomez-Soria I, Iguacel I, Aguilar-Latorre A, Peralta-Marrupe P, Latorre E, Zaldivar JNC, Calatayud E. Cognitive stimulation and cognitive results in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2023 Jan;104:104807. doi: 10.1016/j.archger.2022.104807. Epub 2022 Sep 6.
PubMed 36116285Desai R, Leung WG, Fearn C, John A, Stott J, Spector A. Effectiveness of Cognitive Stimulation Therapy (CST) for mild to moderate dementia: A systematic literature review and meta-analysis of randomised control trials using the original CST protocol. Ageing Res Rev. 2024 Jun;97:102312. doi: 10.1016/j.arr.2024.102312. Epub 2024 Apr 16.
PubMed 38636561Chen X. Effectiveness of cognitive stimulation therapy (CST) on cognition, quality of life and neuropsychiatric symptoms for patients living with dementia: A meta-analysis. Geriatr Nurs. 2022 Sep-Oct;47:201-210. doi: 10.1016/j.gerinurse.2022.07.012. Epub 2022 Aug 6.
PubMed 35940038Cao Y, Wang N, Zhang Q, Shen N, Bai J, Luo X, Liu Y. Effects of cognitive stimulation therapy on patients with dementia: An umbrella review of systematic reviews and meta-analyses. Exp Gerontol. 2023 Jun 15;177:112197. doi: 10.1016/j.exger.2023.112197. Epub 2023 May 6.
PubMed 37146891Davis LC, Diianni AT, Drumheller SR, Elansary NN, D'Ambrozio GN, Herrawi F, Piper BJ, Cosgrove L. Undisclosed financial conflicts of interest in DSM-5-TR: cross sectional analysis. BMJ. 2024 Jan 10;384:e076902. doi: 10.1136/bmj-2023-076902.
PubMed 38199616
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Stimulation Therapy Group for Residential Home Residents With Dementia and Mild Cognitive Impairment-- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07372066
- Acronym / sponsor ID
- CSTSAGE / HU-STA-00001945
- Conditions
- Cognitive Functions
- Keywords
- Cognitive Stimulation Therapy, Calligraphy group, Randomized Controlled trial, Mild cognitive impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Society for the Aged
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- age 60 years or older;
- 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 Simulation Therapy (CST) group, while the control group receives the calligraphy group.
The 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.
The Calligraphy group provides weekly calligraphy activities. It consists of a total of 14 sessions with two sessions per week, each lasting approximately 45 minutes and led by a rehabilitation assistant under the supervision of an occupational therapist.
Outcomes Assessment Tools The primary intervention outcome of this study is the improvement of cognitive ability as measured by the Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Chinese Montreal Cognitive Assessment (MoCA), which have been used as outcome assessment in previous studies of Chinese older adults with MCI.
The secondary intervention outcomes of this study are the improvement in depressive symptoms, engagement, social interaction and quality of life which are assessed by the following standardized scales.
- 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.
- The Chinese Quality of Life-Alzheimer's disease (QoL-AD) is a 13item scale for assessing the QoL in older adults with dementia and MCI. In this study, QoL-AD is completed by both older adults with dementia and MCI as well as their caregivers independently to give self-rated and caregiver-rated QoL.
- 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.
- The Chinese Social Functioning in Dementia scale (SF-DEM) is a 20-item scale for assessing social interactions with family, friends, and the community in older adults with dementia and MCI. 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.
- The Clinical Sustainability Assessment Tool (CSAT) is a 35-item scale for assessing the sustainability of clinical practices for the intervention group. This scale is rated by management and professional staff of SAGE residential homes.
Data Analyses. The analysis is carried out according to the intent-to-treat principle, whereby the multiple imputation method is used for missing data. The data analyses are performed with SPSS 29.0. Within-group intervention effects will be analyzed for all intervention groups using repeated measures one-way analysis of variance (ANOVA). Between group intervention effects are analyzed using 2 (group) x 2 (time) repeated measures of ANOVA. Within and between group effect sizes are computed using Cohen's d, with values of 0.2, 0.5, and 0.8 considered as small, medium, and large respectively.
Fidelity of intervention. Standardized program manuals for CST group and calligraphy group will be designed by the research team to suit the needs and interests of participants with dementia and MCI. The occupational therapists conducting the CST group have completed training on conducting CST group. In addition, they receive the standardized program manuals, training and regular supervision, as well as a surprise check from the research team when conducting the CST group to ensure that the interventions implemented by the occupational therapists meet the guidelines and skills of the standardized program manuals. The rehabilitation assistant conducting the calligraphy group will receive the standardized program manuals, training and regular supervision by an occupational therapist to ensure that the interventions conducted by rehabilitation assistant meet the guidelines and skills of the standardized program manuals.
Ethical Considerations. The ethical aspects of this study were reviewed and approved by the Research Committee of the City University of Hong Kong [Reference No.: HU-STA-00001945]. Written informed consent will be obtained from all participants and their guardians on the day of the screening before participants start receiving the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study adopts a multicentre randomized control trial two arms research design. The Cognitive Stimulation Therapy (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. CST group will be delivered by trained occupational therapists. The Calligraphy group provides weekly calligraphy activities. It consists of a total of 14 sessions with two sessions per week, each lasting approximately 45 minutes and led by a rehabilitation assistant under the supervision of an occupational therapist.
| Arm | Type | Receives |
|---|---|---|
| Cognitive stimulation therapy | Active comparator | Behavioral: Cognitive Stimulation Therapy groupIn 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). |
| Control group | Other | Behavioral: Calligraphy groupThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Stimulation Therapy groupThe 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. | Behavioural | Cognitive stimulation therapy |
| Calligraphy groupThe 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. | Behavioural | Control group |
Primary outcome
ADAS-Cog
Time frame: 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
Time frame: 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.
5 secondary outcomes
Chinese Cornell Scale for Depression in Dementia (CSDD)
Time frame: CSDD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
Chinese Quality of Life-Alzheimer's disease (QoL-AD)
Time frame: QoL-AD will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
Engagement of a person with dementia scale (EPWDS)
Time frame: EPWDS will be used before intervention, after 7 weeks intervention, and 3-month follow-up
The Chinese Social Functioning in Dementia scale (SF-DEM)
Time frame: It will be used before the intervention, after 7-weeks intervention and 3-months follow-up.
Clinical Sustainability Assessment Tool (CSAT)
Time frame: It will be used after 7-weeks intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 39804128Woods B, Rai HK, Elliott E, Aguirre E, Orrell M, Spector A. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2023 Jan 31;1(1):CD005562. doi: 10.1002/14651858.CD005562.pub3.
- Background: PubMed 29791452Wong A, Yiu S, Nasreddine Z, Leung KT, Lau A, Soo YOY, Wong LK, Mok V. Validity and reliability of two alternate versions of the Montreal Cognitive Assessment (Hong Kong version) for screening of Mild Neurocognitive Disorder. PLoS One. 2018 May 23;13(5):e0196344. doi: 10.1371/journal.pone.0196344. eCollection 2018.
- Background: PubMed 14657783Thorgrimsen L, Selwood A, Spector A, Royan L, de Madariaga Lopez M, Woods RT, Orrell M. Whose quality of life is it anyway? The validity and reliability of the Quality of Life-Alzheimer's Disease (QoL-AD) scale. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):201-8. doi: 10.1097/00002093-200310000-00002.
- Background: PubMed 12948999Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
- Background: PubMed 34274004Malone S, Prewitt K, Hackett R, Lin JC, McKay V, Walsh-Bailey C, Luke DA. The Clinical Sustainability Assessment Tool: measuring organizational capacity to promote sustainability in healthcare. Implement Sci Commun. 2021 Jul 17;2(1):77. doi: 10.1186/s43058-021-00181-2.
- Background: PubMed 36116285Gomez-Soria I, Iguacel I, Aguilar-Latorre A, Peralta-Marrupe P, Latorre E, Zaldivar JNC, Calatayud E. Cognitive stimulation and cognitive results in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2023 Jan;104:104807. doi: 10.1016/j.archger.2022.104807. Epub 2022 Sep 6.
- Background: PubMed 38636561Desai R, Leung WG, Fearn C, John A, Stott J, Spector A. Effectiveness of Cognitive Stimulation Therapy (CST) for mild to moderate dementia: A systematic literature review and meta-analysis of randomised control trials using the original CST protocol. Ageing Res Rev. 2024 Jun;97:102312. doi: 10.1016/j.arr.2024.102312. Epub 2024 Apr 16.
- Background: PubMed 35940038Chen X. Effectiveness of cognitive stimulation therapy (CST) on cognition, quality of life and neuropsychiatric symptoms for patients living with dementia: A meta-analysis. Geriatr Nurs. 2022 Sep-Oct;47:201-210. doi: 10.1016/j.gerinurse.2022.07.012. Epub 2022 Aug 6.
- Background: PubMed 37146891Cao Y, Wang N, Zhang Q, Shen N, Bai J, Luo X, Liu Y. Effects of cognitive stimulation therapy on patients with dementia: An umbrella review of systematic reviews and meta-analyses. Exp Gerontol. 2023 Jun 15;177:112197. doi: 10.1016/j.exger.2023.112197. Epub 2023 May 6.
- Background: PubMed 38199616Davis LC, Diianni AT, Drumheller SR, Elansary NN, D'Ambrozio GN, Herrawi F, Piper BJ, Cosgrove L. Undisclosed financial conflicts of interest in DSM-5-TR: cross sectional analysis. BMJ. 2024 Jan 10;384:e076902. doi: 10.1136/bmj-2023-076902.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation Therapy group and Calligraphy group in people with Cognitive Functions, run by City University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim-wan Daniel Young, PhD (+85234428954, dkwyoung@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog (time frame: ADSA_cog will be used before intervention, after 7 weeks intervention, and 3-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07372066, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.