School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Brain and Mind Centre, University of Sydney, Sydney, NSW, 2006, Australia.
BMC Neurol. 2019 Jun 14;19(1):129. doi: 10.1186/s12883-019-1356-9.
Multiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life. Internet-based psychosocial interventions that use mindfulness-based approaches are gathering much attention in recent literature, particularly in the treatment of chronic illnesses. However, no large randomized controlled trials have been done examining the efficacy of such interventions for people with MS (PwMS).
METHODS/DESIGN: This study is a randomised controlled trial of an online mindfulness-based intervention (MBI) for PwMS. Participants will be randomised to receive either the MBI or offered the intervention after a waiting period. All participants will be assessed to determine whether they have a history of recurrent depressive disorder. The primary outcome will be severity of depression, according to the Centre of Epidemiology Depression Scale. Secondary outcomes will be anxiety severity, fatigue, pain and quality of life. Assessments will be conducted pre, post-treatment, at three and six-month follow-up. The online mindfulness-based program was developed in collaboration with end-users (n = 19 PwMS) who gave feedback about what would be feasible and acceptable, and the draft program was reviewed by both experts and patients.
Multiple sclerosis is the most common acquired chronic neurological disease amongst young adults and is associated with a range of symptoms that can be difficult to cope with. In face-to-face interventions, a MBI demonstrated the largest effect in a recent meta-analysis of psychological treatments for PwMS, but MBIs for PwMS have not been delivered online. Hence, this trial will confirm whether MBIs can be efficacious when delivered online. A range of symptoms are assessed as outcomes so that the nature of benefits associated with the online MBI can be ascertained.
ACTRN12618001260213 . Date of Registration: 25/07/2018.
多发性硬化症（MS）是一种中枢神经系统的神经疾病，与许多难以控制的心理社会症状有关，包括情绪低落、焦虑、疲劳和疼痛，以及健康相关生活质量低。基于正念的互联网心理社会干预措施在最近的文献中受到了广泛关注，尤其是在治疗慢性疾病方面。然而，目前还没有大规模的随机对照试验来研究此类干预措施对多发性硬化症患者（PwMS）的疗效。
方法/设计：这是一项针对多发性硬化症患者的在线基于正念的干预（MBI）的随机对照试验。参与者将被随机分配接受 MBI 或在等待期后接受干预。所有参与者都将接受评估，以确定他们是否有复发性抑郁障碍病史。主要结局将根据流行病学抑郁量表评估抑郁严重程度。次要结局将包括焦虑严重程度、疲劳、疼痛和生活质量。评估将在治疗前、治疗后、3 个月和 6 个月随访时进行。在线基于正念的程序是与最终用户（n=19 名 PwMS）合作开发的，他们提供了关于可行性和可接受性的反馈，草案程序还由专家和患者进行了审查。
多发性硬化症是年轻人中最常见的获得性慢性神经疾病，与一系列难以应对的症状有关。在面对面的干预中，最近一项针对多发性硬化症患者的心理治疗的荟萃分析显示，MBI 的效果最大，但 PwMS 的 MBI 尚未在网上提供。因此，这项试验将证实 MBI 在网上提供时是否有效。评估了一系列症状作为结局，以便确定与在线 MBI 相关的收益的性质。
ACTRN12618001260213。注册日期：2018 年 7 月 25 日。
