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

Official title

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

Overview

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

• 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
• 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
• 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

Primary outcome measures

• 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)]
• Chinese Montreal Cognitive Assessment (MoCA) [Time frame: It will be used before and after the intervention and 3-month follow up (over 26-weeks)]

Secondary outcome measures (4)

• Chinese Geriatric Anxiety Inventory (GAI) [Time frame: 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)]
• 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)]
• 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)]

Eligibility criteria

The inclusion criteria:

• 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;
• able to participate independently in group activities; and
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• City University of Hong Kong — Kowloon Tong

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.202 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.000 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 cog PMID 25771249

Identifiers

NCT: NCT07549074 · HU-STA-00001162

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗