McCormick Sheree A, McDonald Kathryn R, Vatter Sabina, Orgeta Vasiliki, Poliakoff Ellen, Smith Sarah, Silverdale Monty A, Fu Bo, Leroi Iracema
Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.
Manchester Academic Health Science Centre, Manchester, UK.
BMJ Open. 2017 Jun 19;7(6):e016801. doi: 10.1136/bmjopen-2017-016801.
Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and 'non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored.
Dyads will be randomised into two treatment arms to receive either 'treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30 min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial.
Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia.
ISRCTN (ISRCTN11455062).
伴有轻度认知障碍的帕金森病（MCI-PD）或帕金森病痴呆（PDD）以及路易体痴呆（DLB）的特征在于运动和“非运动”症状，这些症状会影响生活质量。治疗选择通常限于药物治疗方法。我们开发了一种心理社会干预措施，以改善MCI-PD、PDD或DLB患者的认知、生活质量和陪伴负担。在此，我们描述了一项单盲随机对照试验的方案，以评估该干预措施的可行性、可接受性和耐受性，并评估治疗实施情况。还将探讨干预措施与选定结局指标之间的相互作用以及该干预措施对改善MCI-PD、PDD或DLB患者认知的疗效。
将配对者随机分为两个治疗组，分别接受“常规治疗”（TAU）或专门针对帕金森病相关痴呆症的认知刺激疗法（CST-PD），该疗法包括由研究陪伴者每周三次、每次30分钟、持续10周的居家治疗。将采用混合方法收集有关试验操作方面和治疗实施情况的数据。这将包括记日记、电话随访、配对者清单和研究人员评分。分析将包括描述性统计，总结干预措施的招募情况、可接受性和耐受性以及治疗实施情况。为了初步评估疗效的结局指标，我们将进行推断分析，以检验我们的假设，即与TAU相比，CST-PD可改善认知。还将应用使用主题分析的定性方法。我们的研究结果将为更大规模的确定性试验提供参考。
已获得伦理意见（伦理审查委员会参考号：15/YH/0531）。研究结果将发表在同行评审期刊和会议上。我们将编写报告，供参与帕金森病和痴呆症研究的组织传播。
ISRCTN（ISRCTN11455062）
