Table_1_Improving Self-Awareness of Motor Symptoms in Patients With Parkinson’s Disease by Using Mindfulness – A Study Protocol for a Randomized Controlled Trial.DOCX

ObjectiveThis study aims to increase self-awareness in patients with Parkinson’s disease (PD) using a newly developed mindfulness-based intervention, tailored for the specific needs of PD patients. Its impact on self-awareness and patients’ daily lives is currently being evaluated.
BackgroundRecently, the phenomenon of impaired self-awareness for motor symptoms (ISAm) and some non-motor symptoms has been described in PD. ISAm can negatively influence patients’ daily lives, e.g., by affecting therapy adherence, and is therefore the main focus of this study. The main goal is the development of IPSUM (“Insight into Parkinson’s Disease Symptoms by using Mindfulness”), a PD-specific intervention for increasing patients’ mindfulness and thereby reducing ISAm.
MethodsThe effectiveness of IPSUM is evaluated by comparison of an intervention group with a waitlist-control group. A pre-post design with an additional 8-week follow-up measurement is applied, resulting in three measurement points: before, directly after and 8 weeks after completing the intervention protocol. In total, up to 180 non-depressed PD patients without severe cognitive impairment (non-demented) will be included. The primary outcome is a quantitative score for measuring ISAm. Secondary outcome measures are affective changes, neuropsychological performance and self-awareness of cognition. At pre- and post-measurement an fMRI scan is performed to connect behavioral and neurobiological findings. At post- and follow-up-measurement each patient will take part in a semi-structured interview to explore IPSUM’s impact on self-awareness and patients’ everyday lives.
ResultsThe conception of the intervention protocol is finished, the resulting 8-week program is presented in detail. It has successfully been tested in the first group of patients, their feedback so far was quite promising. Recruitment is ongoing and a first interim analysis will be performed once 30 patients have completed IPSUM.
ConclusionFor the first time, the intervention protocol of IPSUM has successfully been tested in a group of PD patients. As the study goes on, more quantitative data is collected for statistical analyses to evaluate its effectiveness. More qualitative data is collected to evaluate feasibility and effectiveness. We hope for this intervention to be capable of reducing the patients’ ISAm and improving their quality of life on many levels.

【研究目标】本研究旨在针对帕金森病（Parkinson’s disease, PD）患者的特定需求，定制一款全新开发的基于正念的干预疗法，以提升帕金森病患者的自我意识水平。目前，该疗法对患者自我意识及日常生活的影响正处于评估阶段。
【研究背景】近期研究表明，帕金森病患者可出现运动症状相关自我意识受损（Impaired Self-awareness for Motor Symptoms, ISAm）及部分非运动症状相关自我意识障碍。ISAm可通过影响治疗依从性等途径对患者日常生活产生负面影响，因此为本研究的核心关注方向。本研究的主要目标为开发IPSUM（“基于正念洞悉帕金森病症状”，Insight into Parkinson’s Disease Symptoms by using Mindfulness, IPSUM）——一款专为帕金森病患者设计的干预疗法，旨在提升患者的正念水平，进而减轻ISAm症状。
【研究方法】本研究通过设置干预组与等待列表对照组（waitlist-control group），对IPSUM的疗效进行评估。研究采用前后测设计，并额外设置8周随访测量，共包含三个测量时间点：干预方案完成前、完成后即刻以及完成后8周。本研究计划纳入至多180名无重度认知障碍（非痴呆）且未患抑郁症的帕金森病患者。本研究的主要结局指标为用于评估ISAm的量化评分；次要结局指标则包括情感变化、神经心理学表现以及认知自我意识水平。在基线与后测阶段，将对受试者进行功能性磁共振成像（functional magnetic resonance imaging, fMRI）扫描，以关联行为学与神经生物学研究结果。在后测与随访测量阶段，每位受试者将参与半结构化访谈，以探究IPSUM对患者自我意识及日常生活的影响。
【研究结果】目前，本研究的干预方案已完成设计，最终形成的8周干预课程已详细呈现。该方案已在首批受试者中完成试点测试，截至目前受试者的反馈相当积极。当前受试者招募工作正在进行中，当累计30名患者完成IPSUM干预后，将开展首次中期分析。
【研究结论】本研究首次在帕金森病患者群体中完成了IPSUM干预方案的试点测试。随着研究推进，将收集更多量化数据用于统计学分析，以评估该疗法的疗效；同时也将收集更多质性数据，以评估其可行性与有效性。我们期望该干预疗法能够减轻患者的ISAm症状，并从多维度提升患者的生活质量。