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

NCT07549074 — Not applicable, Not yet recruiting, 200 participants, City University of Hong Kong

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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

RegistryNCT07549074, acronym MMI for MCI
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment200 (Estimated)
SponsorCity University of Hong Kong (Other)
ConditionsMild Cognitive Impairment (MCI)
InterventionsCognitive stimulation, Sham Lifestyle Psychoeducation, Lifestyle Education, Multicomponent intervention (Behavioral)
Datesstart 2026-10-01 (estimated), primary completion 2027-12-31 (estimated), completion 2028-06-30 (estimated), first posted 2026-04-23, last updated 2026-09-09
Locations1 site in Hong Kong

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Multicomponent intervention (HBHG)ExperimentalBehavioral: Multicomponent interventionHBHG 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.
Cognitive stimulation (CS)ExperimentalBehavioral: Cognitive stimulationCS provides 12 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker
Lifestyle psychoeducationExperimentalBehavioral: Lifestyle EducationLifestyle 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
Active ControlSham comparatorBehavioral: Sham Lifestyle PsychoeducationActive control provides both sham cognitive stimulation and sham lifestyle psychoeducation
  • Cognitive stimulation (Behavioral): 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 Psychoeducation (Behavioral): 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 Education (Behavioral): 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 intervention (Behavioral): 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

+Outcome measures

Primary outcomes

  • Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [It will be used before and after the intervention and 3 month follow up (over 26-weeks)]: 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
  • Chinese Montreal Cognitive Assessment (MoCA) [It will be used before and after the intervention and 3-month follow up (over 26-weeks)]: • 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).

Secondary outcomes

  • Chinese Geriatric Anxiety Inventory (GAI) [It will be used before and after the intervention and 3-month follow up (over 26-weeks)]: 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
  • Chinese Geriatric Depression Scale (GDS) [It will be used before and after the intervention and 3-month follow up (over 26-weeks)]: 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
  • 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)]: 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).
  • 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)]: 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).

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

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)

+Locations (1)

FacilityCityCountryStatus
City University of Hong KongKowloon Tong, Hong KongHong Kong

+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35977150

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