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

City University of Hong Kong

Status: Begins enrollment in 3 months

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Behavioral: Sham Lifestyle Psychoeducation; Behavioral: Sham cognitive stimulation; Behavioral: Cognitive stimulation; Behavioral: Lifestyle psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT07549074

HU-STA-00001162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Multicomponent intervention (HBHG)

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle psychoeducation

Behavioral: Cognitive stimulation

Cognitive stimulation (CS)

Experimental group

Description:

CS provides 14 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker

Treatment:

Behavioral: Cognitive stimulation

Behavioral: Sham Lifestyle Psychoeducation

Lifestyle psychoeducation

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive stimulation

Behavioral: Sham cognitive stimulation

Active Control

Sham Comparator group

Description:

Active control provides both sham cognitive stimulation and sham lifestyle psychoeducation

Treatment:

Behavioral: Sham cognitive stimulation

Behavioral: Sham Lifestyle Psychoeducation