School of Nursing, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong.
J Adv Nurs. 2021 Aug;77(8):3507-3517. doi: 10.1111/jan.14871. Epub 2021 Apr 28.
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.
This sequential mixed-method study comprises a single-blind randomized controlled trial and a qualitative study.
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.
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.
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.
This study is registered in the ClinicalTrials.gov (NCT04723667) and the HKU Clinical Trials Registry (HKUCTR-2915).
神经精神症状（NPS）在轻度认知障碍（PwMCI）患者中非常普遍。然而，目前的主要治疗方法仅侧重于认知训练。本研究开发了一种赋权心理行为方案，以改善这一临床前队列的 NPS 及其他健康结果。本研究将探索该方案的实证效果以及参与者对该方案的感知和体验。
这是一项包含单盲随机对照试验和定性研究的序贯混合方法研究。
本研究将从社区招募 250 名 PwMCI，并将他们随机分配到干预组或对照组。干预组接受为期 13 周的赋权心理行为方案，重点是促进认知应对和压力适应；对照组接受健康教育方案，作为与痴呆无关的注意力安慰剂。主要结局是 NPS，次要结局包括认知功能、主观记忆抱怨和健康相关生活质量。这些结局将在基线、方案完成时和之后 4 周进行测量。干预组中随机抽取 30 名参与者进行访谈，了解他们对方案的参与体验。本研究于 2020 年 7 月获得资金支持。
鉴于 NPS 的高患病率和对疾病进展的不利影响，其有效管理尚未确定。该赋权心理行为方案以渐进性降低压力阈值（PLST）模型为基础。基于结局的评估和患者体验的结果，可以推进这一研究不足领域的科学发展。
本研究通过在早期疾病阶段压力应对失衡来解释 NPS 的表现，从而增强我们对 PLST 模型的理解。它将为 MCI 的护理管理提供重要的见解，在研究和临床环境中兼顾认知功能和心理健康。
本研究在 ClinicalTrials.gov（NCT04723667）和香港大学临床试验注册处（HKUCTR-2915）注册。
