Mild Cognitive Impairment (MCI)
Conditions
Keywords
Mild Cognitive Impairment, Double-blind Randomized Controlled Trial, Multicomponent intervention, healthy lifestyle, cognitive stimulation
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.
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.
Interventions
BEHAVIORALCognitive stimulation
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
BEHAVIORALSham Lifestyle Psychoeducation
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
BEHAVIORALLifestyle Education
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
BEHAVIORALMulticomponent intervention
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
Sponsors
City University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Hong Kong
Contacts
CONTACTKim-wan Daniel Young, PhD
Outcome results
None listed