CST-HK for Cognition and Well-being in People With Dementia

Dementia of Alzheimer Type Clinical Trial

Official title:

The Implementation of Cognitive Stimulation Therapy Hong Kong Version (CST-HK) for Promoting Cognitive Functioning and Psychosocial Well-being of People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394584
• Other study ID #: EA1802054
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 13, 2021

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This cluster wait-list randomized controlled study investigates the effectiveness of Cognitive Stimulation Therapy (Hong Kong version) delivered by trained supportive staff and volunteers for people in maintaining the quality of life and cognition in people with mild-to-moderate cognitive impairment in community and residential care settings.

Description:

Non-pharmacological interventions such as cognitive training, cognitive rehabilitation, and cognitive stimulation aim at slowing down the cognitive decline experienced by a person with dementia. Cognitive stimulation involves a range of group activities and discussions to enhance general cognitive and social functioning. A meta-analysis of 15 studies with a total of 718 persons with dementia showed evidence of benefits of cognitive stimulation on cognitive function, quality of life, and self-reported well-being of the people with dementia . The benefits appeared to add on to medication effects. The clinical improvements in verbal and visual memory, orientation, and auditory comprehension after cognitive stimulation appeared to be able to translate into improvements in real world activity, as seen in enhancement of the communication and social interaction of persons with dementia.

In view of the current evidence, cognitive stimulation is recommended by the National Institute for Health and Clinical Excellence and the Alzheimer's Disease International as an evidence-based, non-pharmacological intervention to be offered to all people with mild-to-moderate dementia. A standard protocol of cognitive stimulation therapy with evidence is a 7-week intervention developed by Spector and her colleagues. It is a series of standardized, well-structured stimulating activities, implemented in a sensitive, respectful and person-centered manner. Group CST typically involves 14 sessions of 45-minute group activities that required cognitive processing delivered over a 7-week period (2 sessions per week, with approximately 45 mins per session). The group size was standardized to be 6 to 8 persons. People with dementia would participate in each of the 14 designated theme activities during each session. The activities aimed at stimulating and engaging persons with dementia in an active way, and providing an optimal learning environment and the positive social benefits of group therapy. Cognitive stimulation therapy can be delivered by non-specialist healthcare workers with minimum training . This allows CST to be used in low-resource environment. Manuals in different languages had been published for the group leaders to follow. Due to this advantage of high reproducibility with high quality evidence support, CST was widely adopted in over 20 countries.

In Hong Kong, there is currently no recommendations or routine provision of cognitive stimulation. In 2015, the standard group CST protocol was culturally adapted for and tested in Chinese people with dementia in Hong Kong (CST-HK). The observed improvements in cognitive outcome was in line with that of overseas studies. The protocol appeared to be feasible and acceptable to Hong Kong Chinese, with high attendance rate (92%) and low attrition rate (13%). Cultural issues identified in the pilot have been published and recommendations were made in adapting the protocol to the Hong Kong cultural settings. A Hong Kong Chinese version of the manual for CST group leaders has been published in 2017.

This study aims to investigate the effectiveness of CST-HK delivered by trained non-professional group leaders in maintaining the quality of life and cognition of people with mild-to-moderate cognitive impairment . As part of project evaluation, it aims to test the effectiveness of CST-HK compared with a wait-list control group who will receive care as usual during the waiting period.

Research Objectives The research aims to investigate the effectiveness of CST-HK among people with mild-to-moderate cognitive impairment in Hong Kong in a larger scale across service settings. It also aims to explore the effectiveness of CST-HK delivered by non-professional staff, as a possible solution to address the shortage of specialized healthcare manpower and increasing demands of non-pharmacological interventions for people with dementia.

Hypotheses The research hypothesized that, compared with the wait-list control group, the group who have received a 7-week (14-session) CST-HK intervention delivered by trained non-professional staff will show greater improvement or maintenance of (1) quality of life; and (2) cognitive performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Having a clinical diagnosis of mild-to-moderate dementia, or a cognitive assessment result suggestive of mild-to-moderate cognitive impairment;

• Being able to communicate and understand Cantonese;

• Being able to hear and see well enough to participate in cognitive stimulation activities;

• Having a caregiver who is able to give joint informed consent.

Exclusion Criteria:

• Having major illness(es) that would affect participation (e.g., clinically significant depressive symptoms or psychotic disorders);

• Having behavioural and psychological symptoms (e.g., aggression, inappropriate sexual behaviours, hallucination, delusion) that would interfere with participation in the intervention.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type

Intervention

Behavioral:
• Cognitive Stimulation Therapy
Cognitive stimulation therapy is a non-pharmacological intervention for people with dementia at mild to moderate stages. Group cognitive stimulation therapy is a 14-session intervention delivered twice every week for 7 weeks. In each session, mentally stimulating activities are conducted around a specific themed, such as current affairs, word association, categorising objects, and number game. Each group consists of eight people with similar levels of cognitive impairment, facilitated by two group leaders who lead the activities according to 18 key principles of the therapy, including new associations, opinions rather than facts, implicit learning, and person-centred.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Young Women's Christian Association	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong, Hong Kong Young Women's Christian Association

Country where clinical trial is conducted

Hong Kong, 

References & Publications (19)

Aguirre E, Woods RT, Spector A, Orrell M. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials. Ageing Res Rev. 2013 Jan;12(1):253-62. doi: 10.1016/j.arr.2012.07.001. Epub 2012 Aug 7. Review. — View Citation

Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD003260. doi: 10.1002/14651858.CD003260.pub2. Review. — View Citation

Chan IW, Chu LW, Lee PW, Li SW, Yu KK. Effects of cognitive function and depressive mood on the quality of life in Chinese Alzheimer's disease patients in Hong Kong. Geriatr Gerontol Int. 2011 Jan;11(1):69-76. doi: 10.1111/j.1447-0594.2010.00643.x. Epub 2010 Aug 25. — View Citation

Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85. — View Citation

Hall L, Orrell M, Stott J, Spector A. Cognitive stimulation therapy (CST): neuropsychological mechanisms of change. Int Psychogeriatr. 2013 Mar;25(3):479-89. doi: 10.1017/S1041610212001822. Epub 2012 Nov 12. — View Citation

Khan Z, Corbett A, Ballard C. Cognitive stimulation therapy: training, maintenance and implementation in clinical trials. Pragmat Obs Res. 2014 Apr 5;5:15-19. eCollection 2014. Review. — View Citation

Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. — View Citation

National Collaborating Centre for Mental Health (UK). Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care. Leicester (UK): British Psychological Society (UK); 2007. — View Citation

Orrell M, Hoe J, Charlesworth G, Russell I, Challis D, Moniz-Cook E, Knapp M, Woods B, Hoare Z, Aguirre E, Toot S, Streater A, Crellin N, Whitaker C, d'Amico F, Rehill A. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) - evidence, development and evaluation of complex interventions. Southampton (UK): NIHR Journals Library; 2017 Feb. — View Citation

Paddick SM. Cognitive stimulation therapy as a low-resource intervention for dementia in sub-saharan africa: Initial results of a controlled trial. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 11(7):607, 2015.

Prince M, Bryce R, Ferri C. World Alzheimer Report 2011: The benefits of early diagnosis and intervention. Alzheimer's Disease International (ADI) 2011.

Prince M, Wimo A, Guerchet M, Ali G, Wu Y, Prina M. World Alzheimer Report 2015-The Global Impact of Dementia: An analysis of prevalence, incidence, cost and trends. Alzheimer's Disease International (ADI) 2015.

Spector A, Orrell M, Woods B. Cognitive Stimulation Therapy (CST): effects on different areas of cognitive function for people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1253-8. doi: 10.1002/gps.2464. — View Citation

Spector A, Thorgrimsen L, Woods B, Orrell M. Making a difference: An evidence-based group program to offer cognitive stimulation therapy (CST) to people with dementia; the manual for group leaders (text in chinese). Hong Kong: Hong Kong University Press 2017.

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. — View Citation

Wong GHY, Yek OPL, Zhang AY, Lum TYS, Spector A. Cultural adaptation of cognitive stimulation therapy (CST) for Chinese people with dementia: multicentre pilot study. Int J Geriatr Psychiatry. 2018 Jun;33(6):841-848. doi: 10.1002/gps.4663. Epub 2017 Jan 11. — View Citation

Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2. Review. — View Citation

World Health Organization. Dementia: a public health priority. World Health Organization 2012.

Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life in Alzheimer's Disease	A 13-item scale for self-rating and proxy rating on the quality of life of persons with dementia. The total score ranges from 3 to 52, higher scores means a better outcome.	Change from Baseline Quality of Life in Alzheimer's Disease at 8 weeks
Primary	Alzheimer's Disease Assessment Scale- Cognitive Subscale	A cognitive function assessment scale for people with dementia covering 11 cognitive domains. The total score ranges from 0 to 70, higher score represents worse outcome.	Change from Baseline Alzheimer's Disease Assessment Scale- Cognitive Subscale at 8 weeks