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An empowerment-psycho-behavioral program on neuropsychiatric symptoms in persons with mild cognitive impairment: Study protocol of a randomized controlled trial.

AIMS
Neuropsychiatric symptoms (NPS) are highly prevalent among persons with mild cognitive impairment (PwMCI). However, the mainstay of treatments only focuses on cognitive training. This study develops an empowerment-psycho-behavioural programme to improve the NPS and other health outcomes of this preclinical cohort. The empirical effects and the participants' perception and experience of the programme will be explored.


DESIGN
This sequential mixed-method study comprises a single-blind randomized controlled trial and a qualitative study.


METHODS
This study will recruit 250 PwMCI from the community and randomize them to either the intervention group to receive a 13-week empowerment-psycho-behavioural programme which focuses on promoting cognitive coping and stress adaptation, or the control group to receive a health education programme which serves as an attention placebo with content unrelated to dementia. The primary outcome is NPS, and the secondary outcomes include cognitive function, subjective memory complaints and health-related quality of life. These outcomes will be measured at baseline, upon completing the programme and 4 weeks thereafter. A purposive sample of 30 participants from the intervention group will be interviewed for their engagement experience in the programme. This study received funding support in July 2020.


DISCUSSION
Given the high prevalence and detrimental effects of NPS on disease progression, effective management is yet to be determined. Underpinned by the Progressively Lowered Stress Threshold (PLST) Model, the empowerment-psycho-behavioural programme is designed. Results on the outcome-based evaluation and the patients' experience can advance the science in this under-addressed area.


IMPACT
This study enhances our understanding of the PLST Model in explaining the manifestations of NPS by the stress-coping disequilibrium at the early disease stage. It will shed important insight into the care management of MCI to attend both cognition function and psychological well-being in research and clinical context.


TRIAL REGISTRATION
This study is registered in the ClinicalTrials.gov (NCT04723667) and the HKU Clinical Trials Registry (HKUCTR-2915).