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Mild Cognitive Impairment (MCI)MMI for MCINCT07549074

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

A study testing Cognitive stimulation, Lifestyle Education and Multicomponent intervention in people with Mild Cognitive Impairment (MCI), run by City University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
Cognitive stimulation, Lifestyle Education and Multicomponent intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteHong Kong
Study dates
1 Oct 2026to 30 Jun 2028
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

The inclusion criteria:

  1. age 60 years or older;
  2. 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);
  3. awareness of memory loss with memory complaints;
  4. member of collaborating elderly centre;
  5. able to participate independently in group activities; and
  6. fluent in Cantonese.

The exclusion criteria:

  1. diagnosed with dementia;
  2. unable to participate independently in group activities;
  3. exhibiting disruptive behavior; and
  4. severely impaired by physical disabilities (e.g. a severe hearing problem)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kim-wan Daniel Young, PhD contact

+85234428954 ext. 8954

dkwyoung@cityu.edu.hk

Hong Kong1 site

  • City University of Hong Kong

    Kowloon Tong, Hong Kong

    Young Kim-wan, PhD, 34428954 ext. 8954, dkwyoung@cityu.edu.hk

Other trials in Hong Kong

About this study

Official title: Multicomponent Intervention With Healthy Lifestyle Psychoeducation and Cognitive Stimulation to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment-A Double-blind Randomized Control Trial

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.

Read the detailed description

Background. Mild cognitive impairment (MCI) is an intermediate stage between cognitively healthy ageing and dementia, with a prevalence rate of 15.6% in older adults worldwide. Older adults with MCI have a higher risk of developing dementia than older people without MCI. Multicomponent interventions that promote a healthy lifestyle to improve cognitive abilities are promising and more favorable than single interventions for older adults with MCI. However, there is a lack of short-term and effective multicomponent interventions.

Objective: This study aims to evaluate the effectiveness of a new short-term multicomponent intervention based on the Integrative Body-Mind-Spiritual Model, an Eastern health care approach that aims to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. The multicomponent intervention provides healthy lifestyle psychoeducation and cognitive stimulation, delivered by social workers within 12-weeks. The efficacy and effect sizes of the multicomponent intervention will be compared with those of two single interventions, i.e. healthy lifestyle psychoeducation and cognitive stimulation. The underlying mechanism of change will be investigated.

Hypothesis: (i) the multicomponent intervention leads to significant improvement in cognitive ability, anxiety, depression, healthy lifestyle behavior, and subjective well-being in older adults with MCI at both post-intervention and 3-month follow-up; (ii) the multicomponent intervention leads to larger intervention effects compared to the two single interventions, i.e., cognitive stimulation and lifestyle psychoeducation; and (iii) improvement in cognitive ability is predicted by improvement in healthy lifestyle behavior, depressive and anxiety symptoms.

Research methods: 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. A previous pilot study of the multicomponent intervention yielded positive outcomes, supporting the feasibility of this study.

Significance: This study aims to make a seminal contribution to theoretical advances in the application of Integrative Body-Mind-Spiritual Model in multicomponent interventions to improve the cognitive abilities of older adults with MCI through the promotion of bio-psycho-social-spiritual health, and to investigate its effectiveness and underlying mechanism of change.

Being tested
Cognitive stimulation, Sham Lifestyle Psychoeducation, Lifestyle Education, Multicomponent intervention
Keywords
Mild Cognitive Impairment, Double-blind Randomized Controlled Trial, Multicomponent intervention, healthy lifestyle, cognitive stimulation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive stimulationBehavioural

    Cognitive stimulation provides 12 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker/counsellor

  • Sham Lifestyle PsychoeducationBehavioural

    Sham Lifestyle Psychoeducation provides 12 sessions of reading, followed by a creative art activity. One session per week, each session lasting approximately 45 minutes and led by a social worker/counsellor

  • Lifestyle EducationBehavioural

    Provides weekly psychoeducation sessions, with a total of 12 sessions over a 12-week period, with one session per week each session lasting approximately 45 minutes

  • Multicomponent interventionBehavioural

    Provides both cognitive stimulation and lifestyle psychoeducation, with a total of 12 sessions over a 12-week period, with one sessions per week delivered by a social worker. Six sessions of cognitive stimulation and Six session of lifestyle psychoeducation are delivered each week, with each session lasting approximately 45 minutes

Study groups in NCT07549074
Study groupRoleWhat they receive
Multicomponent intervention (HBHG)ExperimentalHBHG provides cognitive stimulation and lifestyle psychoeducation, with a total of 12 sessions, one sessions per week, with each session lasting approximately 45 minutes and led by a social worker.
Receives: Behavioral: Multicomponent intervention
Cognitive stimulation (CS)ExperimentalCS provides 12 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker
Receives: Behavioral: Cognitive stimulation
Lifestyle psychoeducationExperimentalLifestyle psychoeducation provides 12 psychoeducation sessions on healthy lifestyles, one session per week, each session lasts about 45 minutes and is led by a social worker
Receives: Behavioral: Lifestyle Education
Active ControlSham comparatorActive control provides both sham cognitive stimulation and sham lifestyle psychoeducation
Receives: Behavioral: Sham Lifestyle Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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).

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

Secondary outcomes (4)

  1. Chinese Geriatric Anxiety Inventory (GAI)

    GAI is a 20-item scale for assessing self-reported anxiety symptoms in older adults with MCI with good validity and internal consistency (Cronbach's α = 0.9; Yan et al., 2014). Each item (e.g., I find it hard to relax) is answered with a dichotomous response of agree or disagree. A cut-off GAI score of ≥ 11 indicates clinical anxiety (Yan et al., 2014), which is adopted in this study

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

  2. Chinese Geriatric Depression Scale (GDS)

    GDS is a 15-item scale for assessing self-reported depressive symptoms in older adults with MCI with satisfactory validity, internal consistency (Cronbach's α = 0.9; Chiu et al., 1994b). Each item (e.g., Do you often get bored?) is answered with a dichotomous response of yes or no. A cut-off GDS score of ≥ 8 indicates clinical depression (Chiu et al., 1994b), which is adopted in this study

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

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

    HPLP-SF is a 30-item scale for assessing self-reported healthy lifestyle behavior in six dimensions, including: self-actualization, health responsibility, exercise, nutrition, interpersonal support and stress management, with satisfactory reliability and validity (Cronbach's α = 0.90; Teng et al, 2010). Each item (e.g., engaging in a supervised exercise class or activity) is rated on a 5-point Likert-type scale ranging from 1 (never) to 4 (always).

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

  4. Chinese WHO 5-item Well-Being Index (WHO-5)

    WHO-5 is a 5-item scale for assessing subjective wellbeing with satisfactory validity and internal consistency (Cronbach's α = 0.85; Fung et al., 2022). Each item (e.g., feel a sense of companionship in life) is rated on a 5-point Likert-type scale ranging from 1 (very dissatisfied) to 5 (very satisfied).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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 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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07549074
Sponsor's protocol ID
HU-STA-00001162
Acronym
MMI for MCI
Status last verified
Apr 2026
First submitted
18 Apr 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29781725

  • 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.

    PubMed 25125421

  • 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.

    PubMed 24252312

  • 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.

    PubMed 32534025

  • 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.

    PubMed 20557380

  • 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.

    PubMed 38179562

  • 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.

    PubMed 29282327

  • 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.

    PubMed 25771249

  • 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.

    PubMed 32595879

  • 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.

    PubMed 35433612

  • 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.

    PubMed 11056778

  • 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.

    PubMed 7701365

  • 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.

    PubMed 35887711

  • 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.

    PubMed 29679658

  • 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.

    PubMed 35977150

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive stimulation, Lifestyle Education and Multicomponent intervention in people with Mild Cognitive Impairment (MCI), 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?

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: opening soon, as of the sponsor's last update on 9 Sep 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. Some participants in this study may receive a placebo. 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 ext. 8954, dkwyoung@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: It will be used before and after the intervention and 3 month follow up (over 26-weeks)). 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 NCT07549074, which also lists 15 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 9 Sep 2026.

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