Multicomponent Intervention to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment (MMI for MCI)

April 18, 2026 updated by: Daniel Young, City University of Hong Kong

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • Hong Kong
      • Kowloon Tong, Hong Kong, Hong Kong
        • City University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent intervention (HBHG)
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
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
Behavioral: Lifestyle psychoeducation
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
Experimental: Cognitive stimulation (CS)
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
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
Behavioral: Sham Lifestyle Psychoeducation
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
Experimental: Lifestyle psychoeducation
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
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
Behavioral: Sham cognitive stimulation
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
Sham Comparator: Active Control
Active control provides both sham cognitive stimulation and sham lifestyle psychoeducation
Behavioral: Sham Lifestyle Psychoeducation
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
Behavioral: Sham cognitive stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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)
Time Frame: 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).
It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chinese Geriatric Anxiety Inventory (GAI)
Time Frame: 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
It will be used before and after the intervention and 3-month follow up (over 26-weeks)
Chinese Geriatric Depression Scale (GDS)
Time Frame: 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
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)
Time Frame: 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).
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)
Time Frame: 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).
It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-STA-00001162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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