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

NCT07372066 | Recruiting

• 1 other identifier: HU-STA-00001945
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Functions

Keywords

Cognitive Stimulation Therapy; Calligraphy group; Randomized Controlled trial; Mild cognitive impairment; Dementia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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

Study Arms (2)

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).

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.

Behavioral: Calligraphy group

Interventions

Calligraphy group BEHAVIORAL

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.

Control group

Cognitive Stimulation Therapy group BEHAVIORAL

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.

Cognitive stimulation therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City University of Hong Kong: lead
• The Hong Kong Society for the Aged: collaborator

Study Sites (1)

SAGE Old Age Homes

Hong Kong, Hong Kong, Hong Kong

RECRUITING

Related Publications (10)

• 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.

  PMID: 39804128 BACKGROUND

• Wong 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.

  PMID: 29791452 BACKGROUND

• Thorgrimsen 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.

  PMID: 14657783 BACKGROUND

• Spector 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.

  PMID: 12948999 BACKGROUND

• Malone 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.

  PMID: 34274004 BACKGROUND

• Gomez-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.

  PMID: 36116285 BACKGROUND

• Desai 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.

  PMID: 38636561 BACKGROUND

• Chen 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.

  PMID: 35940038 BACKGROUND

• Cao 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.

  PMID: 37146891 BACKGROUND

• Davis 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.

  PMID: 38199616 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kim-wan Daniel Young, PhD

CONTACT

+85234428954; dkwyoung@cityu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-02

Locations

HK (1)