Division of Neuroscience and Experimental Psychology, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.
Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.
J Neurol. 2019 Jul;266(7):1756-1770. doi: 10.1007/s00415-019-09329-6. Epub 2019 Jun 4.
Drug-based therapeutic approaches for Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB) are moderately effective and not always tolerated. Tailoring psychosocial approaches in PDD and DLB may offer additional support and improve outcomes. We adapted home-based, care partner-delivered Cognitive Stimulation Therapy (CST) for individuals with PDD or DLB and their care partners (CST-PD).
To evaluate the feasibility, acceptability, and tolerability of CST-PD.
This randomised controlled trial used mixed methods, including a process evaluation. People with PDD, DLB or mild cognitive impairment in PD (PD-MCI) and their care partners were randomised to 12 weeks of treatment as usual (TAU) or CST-PD. Outcomes were feasibility of the study conduct (i.e., recruitment, retention rate) and acceptability and tolerability of the intervention. Measures included rating scales, researcher field notes, therapy diaries, and exploratory clinical and care partner efficacy measures.
The recruitment target was met with 76 consenting participant-dyads. Retention in both arms was high at over 70%. More than 90% of dyads undertook discrete sessions greater than 20 min duration, but the average number of sessions completed was lower than the recommended dose. Acceptability ratings (i.e., interest, motivation and sense of achievement) of the intervention were high. Participants reported no serious adverse events related to the intervention.
The field of psychosocial interventions for PDD and DLB is newly emerging, and we demonstrated that this type of intervention is acceptable and well tolerated. Evaluating its clinical effectiveness in a full-scale randomized controlled clinical trial is warranted.
The trial is a psychosocial intervention with an allocated ISRCTN number 11455062.
针对帕金森病痴呆(PDD)和路易体痴呆(DLB)的药物治疗方法效果中等,且并非总能被患者耐受。针对 PDD 和 DLB 患者采用社会心理干预可能会提供额外的支持,并改善预后。我们改编了基于家庭的、由照顾者实施的认知刺激疗法(CST),用于 PDD 或 DLB 患者及其照顾者(CST-PD)。
评估 CST-PD 的可行性、可接受性和耐受性。
这是一项随机对照试验,采用了混合方法,包括过程评估。将 PDD、DLB 或 PD 合并轻度认知障碍(PD-MCI)患者及其照顾者随机分配至接受 12 周的常规治疗(TAU)或 CST-PD。结局为研究实施的可行性(即招募、保留率)以及干预措施的可接受性和耐受性。评估措施包括评定量表、研究者现场记录、治疗日记,以及探索性临床和照顾者疗效评估。
招募目标完成,76 对同意参与的患者-照顾者完成了入组。两组的保留率均超过 70%。超过 90%的患者-照顾者完成了时长超过 20 分钟的离散疗程,但完成的疗程数低于推荐剂量。干预措施的可接受性评分(即兴趣、动机和成就感)较高。患者报告无与干预相关的严重不良事件。
针对 PDD 和 DLB 的社会心理干预领域尚属新兴领域,我们证明了这种干预类型是可接受且耐受良好的。值得在一项全面的随机对照临床试验中评估其临床疗效。
该试验是一种社会心理干预,分配了 ISRCTN 编号:11455062。