Multicomponent Intervention to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment

NCT07549074 | Not Yet Recruiting

• 1 other identifier: HU-STA-00001162
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The research aims to investigate the effectiveness of a new short-term multicomponent intervention to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. In this study, the multicomponent intervention consists of healthy lifestyle psychoeducation and cognitive stimulation. This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment; Double-blind Randomized Controlled Trial; Multicomponent intervention; healthy lifestyle; cognitive stimulation

Outcome Measures

Primary Outcomes (2)

• Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (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 (e.g. a list of 10 words is read by the subject, and then the subject is asked to verbally recall as many of the words as possible), naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, language, comprehension of spoken language, and word finding difficulty

  It will be used before and after the intervention and 3 month follow up (over 26-weeks)

• Chinese Montreal Cognitive Assessment (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 MCI (Chen et al, 2021). It assesses global and specific cognitive abilities, including memory recall (e.g., I read some words to you earlier, which I asked you to remember. Tell me as many of those words as you can remember), attention, concentration, executive functions, language, visuospatial skills, abstract reasoning, calculation and orientation (Yeung et al., 2014).

  It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Secondary Outcomes (4)

• Chinese Geriatric Anxiety Inventory (GAI)

  It will be used before and after the intervention and 3-month follow up (over 26-weeks)

• Chinese Geriatric Depression Scale (GDS)

  It will be used before and after the intervention and 3-month follow up (over 26-weeks)

• Chinese Health-Promoting Lifestyle Profile-Short form (HPLP-SF)

  It will be used before and after the intervention and 3-month follow up (over 26-weeks)

• Chinese WHO 5-item Well-Being Index (WHO-5)

  It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Study Arms (4)

Multicomponent intervention (HBHG)

EXPERIMENTAL

HBHG provides cognitive stimulation and lifestyle psychoeducation, with a total of 28 sessions, two sessions per week (one session of cognitive stimulation and one session of lifestyle psychoeducation), with each session lasting approximately 45 minutes and led by a social worker.

Behavioral: Cognitive stimulation; Behavioral: Lifestyle psychoeducation

Cognitive stimulation (CS)

EXPERIMENTAL

CS provides 14 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker

Behavioral: Cognitive stimulation; Behavioral: Sham Lifestyle Psychoeducation

Lifestyle psychoeducation

EXPERIMENTAL

Lifestyle psychoeducation provides 14 psychoeducation sessions on healthy lifestyles, one session per week, each session lasts about 45 minutes and is led by a social worker

Behavioral: Cognitive stimulation; Behavioral: Sham cognitive stimulation

Active Control

SHAM COMPARATOR

Active control provides both sham cognitive stimulation and sham lifestyle psychoeducation

Behavioral: Sham cognitive stimulation; Behavioral: Sham Lifestyle Psychoeducation

Interventions

Cognitive stimulation BEHAVIORAL

Cognitive stimulation provides 14 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker/counsellor

Cognitive stimulation (CS); Lifestyle psychoeducation; Multicomponent intervention (HBHG)

Lifestyle psychoeducation BEHAVIORAL

Lifestyle psychoeducation provides 14 psychoeducation sessions on healthy lifestyles, one session per week, each session lasts about 45 minutes and is led by a social worker/counsellor

Multicomponent intervention (HBHG)

Sham cognitive stimulation BEHAVIORAL

Sham cognitive stimulation provides 14 sessions of searching website information on local leisure and recreational activities, followed by a quiz. One session per week, each session lasting approximately 45 minutes and led by a social worker/counsellor

Active Control; Lifestyle psychoeducation

Sham Lifestyle Psychoeducation BEHAVIORAL

Sham Lifestyle Psychoeducation provides 14 sessions of reading standardized educational material on MCI provided by the government (available at https://www.healthyhkec.org/ healthcare/eldercare/newhabit/), followed by a quiz. One session per week, each session lasting approximately 45 minutes and led by a social worker/counsellor

Active Control; Cognitive stimulation (CS)

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 mild neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision) (American Psychiatric Association, 2022); Participants who are not diagnosed with MCI will undergo a screening assessment by a research assistant using both the Montreal Cognitive Assessment (MoCA) (Chinese version) with a total score of 19 to 21 represents MCI. (Yeung et al., 2014);
• awareness of memory loss with memory complaints;
• member of collaborating elderly centre;
• able to participate independently in group activities; and
• fluent in Cantonese.

You may not qualify if:

• Those diagnosed with dementia, unable to participate independently in group activities, exhibiting disruptive behavior and/or severely impaired by physical disabilities (e.g. a severe hearing problem) are excluded.

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (1)

City University of Hong Kong

Kowloon Tong, Hong Kong, Hong Kong

Location

Related Publications (15)

• Young DK, Ng PY, Kwok T, Ho F, Cheng D, Mak V, Lau A. The effects of an expanded cognitive stimulation therapy model on the improvement of cognitive ability of elderly with mild stage Dementia living in a community - a randomized waitlist controlled trial. Aging Ment Health. 2019 Jul;23(7):855-862. doi: 10.1080/13607863.2018.1471586. Epub 2018 May 21.

  PMID: 29781725 BACKGROUND

• Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.

  PMID: 25125421 BACKGROUND

• Yan Y, Xin T, Wang D, Tang D. Application of the Geriatric Anxiety Inventory-Chinese Version (GAI-CV) to older people in Beijing communities. Int Psychogeriatr. 2014 Mar;26(3):517-23. doi: 10.1017/S1041610213002007. Epub 2013 Nov 20.

  PMID: 24252312 BACKGROUND

• Whitty E, Mansour H, Aguirre E, Palomo M, Charlesworth G, Ramjee S, Poppe M, Brodaty H, Kales HC, Morgan-Trimmer S, Nyman SR, Lang I, Walters K, Petersen I, Wenborn J, Minihane AM, Ritchie K, Huntley J, Walker Z, Cooper C. Efficacy of lifestyle and psychosocial interventions in reducing cognitive decline in older people: Systematic review. Ageing Res Rev. 2020 Sep;62:101113. doi: 10.1016/j.arr.2020.101113. Epub 2020 Jun 10.

  PMID: 32534025 BACKGROUND

• Teng HL, Yen M, Fetzer S. Health promotion lifestyle profile-II: Chinese version short form. J Adv Nurs. 2010 Aug;66(8):1864-73. doi: 10.1111/j.1365-2648.2010.05353.x. Epub 2010 Jun 16.

  PMID: 20557380 BACKGROUND

• Qi Y, Zhang Z, Fu X, Han P, Xu W, Cao L, Guo Q. Adherence to a healthy lifestyle and its association with cognitive impairment in community-dwelling older adults in Shanghai. Front Public Health. 2023 Dec 18;11:1291458. doi: 10.3389/fpubh.2023.1291458. eCollection 2023.

  PMID: 38179562 BACKGROUND

• Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Practice guideline update summary: Mild cognitive impairment [RETIRED]: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Jan 16;90(3):126-135. doi: 10.1212/WNL.0000000000004826. Epub 2017 Dec 27.

  PMID: 29282327 BACKGROUND

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 BACKGROUND

• Gomez-Soria I, Peralta-Marrupe P, Plo F. Cognitive stimulation program in mild cognitive impairment A randomized controlled trial. Dement Neuropsychol. 2020 Apr-Jun;14(2):110-117. doi: 10.1590/1980-57642020dn14-020003.

  PMID: 32595879 BACKGROUND

• Fung SF, Kong CYW, Liu YM, Huang Q, Xiong Z, Jiang Z, Zhu F, Chen Z, Sun K, Zhao H, Yu P. Validity and Psychometric Evaluation of the Chinese Version of the 5-Item WHO Well-Being Index. Front Public Health. 2022 Mar 30;10:872436. doi: 10.3389/fpubh.2022.872436. eCollection 2022.

  PMID: 35433612 BACKGROUND

• 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.

  PMID: 11056778 BACKGROUND

• Chiu HF, Lee HC, Wing YK, Kwong PK, Leung CM, Chung DW. Reliability, validity and structure of the Chinese Geriatric Depression Scale in a Hong Kong context: a preliminary report. Singapore Med J. 1994 Oct;35(5):477-80.

  PMID: 7701365 BACKGROUND

• Carcelen-Fraile MDC, Llera-DelaTorre AM, Aibar-Almazan A, Afanador-Restrepo DF, Baena-Marin M, Hita-Contreras F, Brandao-Loureiro V, Garcia-Garro PA, Castellote-Caballero Y. Cognitive Stimulation as Alternative Treatment to Improve Psychological Disorders in Patients with Mild Cognitive Impairment. J Clin Med. 2022 Jul 7;11(14):3947. doi: 10.3390/jcm11143947.

  PMID: 35887711 BACKGROUND

• Bruderer-Hofstetter M, Rausch-Osthoff AK, Meichtry A, Munzer T, Niedermann K. Effective multicomponent interventions in comparison to active control and no interventions on physical capacity, cognitive function and instrumental activities of daily living in elderly people with and without mild impaired cognition - A systematic review and network meta-analysis. Ageing Res Rev. 2018 Aug;45:1-14. doi: 10.1016/j.arr.2018.04.002. Epub 2018 Apr 18.

  PMID: 29679658 BACKGROUND

• Bai W, Chen P, Cai H, Zhang Q, Su Z, Cheung T, Jackson T, Sha S, Xiang YT. Worldwide prevalence of mild cognitive impairment among community dwellers aged 50 years and older: a meta-analysis and systematic review of epidemiology studies. Age Ageing. 2022 Aug 2;51(8):afac173. doi: 10.1093/ageing/afac173.

  PMID: 35977150 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A research staff, who is blinded to the group allocation and does not involve in the delivery of group interventions, conduct the intervention outcomes assessment of the participants before and after the intervention and after 3 months. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving.

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

HK (1)