About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
diagnosed with dementia;
unable to participate independently in group activities;
exhibiting disruptive behavior; and
severely impaired by physical disabilities (e.g. a severe hearing problem)
Trial design
Parallel
Treatments tested in this trial
Cognitive stimulation
BehavioralCognitive 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
BehavioralSham 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
BehavioralProvides 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
BehavioralProvides 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
Treatment groups
Trial outcomes
Primary outcomes
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
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).
Secondary outcomes
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
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
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).
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).
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