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

April 21, 2026 updated by: Daniel Young, City University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

  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 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 Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Recruiting
        • SAGE Old Age Homes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Behavioral: Cognitive Stimulation Therapy 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. CST groups will be delivered by trained occupational therapists.
Other: 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.
Behavioral: Calligraphy group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
ADSA_cog will be used before intervention, after 7 weeks intervention, and 3-month follow-up.
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.
MoCA will be used before intervention, after 7 weeks intervention, and 3-month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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 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.
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.
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.
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
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.
It will be used after 7-weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City University of Hong Kong

Collaborators

The Hong Kong Society for the Aged

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-STA-00001945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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