Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high prevalence of cognitive difficulties seen in MS, there is a lack of developed programmes that target cognition, while also supporting patients by helping them to function well in everyday life. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention. It addresses the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the current research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. The focus is on feasibility outcomes as well as functioning associated with cognitive difficulty and secondary outcomes related to cognition, fatigue and quality of life. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment as usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The primary outcome measure is the goal attainment scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention and at 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants’ perspectives will also be examined as part of the feasibility study. Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. In the event that results indicate efficacy, study findings will suggest that COB-MS requires consideration as a means of enhancing cognitive and daily functioning in people living with MS. ISRCTN: ISRCTN11462710. Registered on 9 September 2019.

中文翻译：

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评估针对多发性硬化症 (COB-MS) 患者的基于认知职业的计划的可行性和初步疗效：可行性整群随机对照试验方案

多发性硬化症 (MS) 患者经历的认知困难会影响他们的生活质量和日常功能，从儿童保育和工作到社交和自我护理活动。尽管 MS 中认知困难的发生率很高，但缺乏针对认知的开发程序，同时还通过帮助患者在日常生活中发挥良好功能来支持他们。针对 MS 患者的基于认知职业的计划 (COB-MS) 是作为一种整体的、个性化的认知康复干预而开发的。它解决了 MS 中出现的广泛症状和功能困难，包括维持就业、社交活动、家庭管理和自我保健的能力。当前研究的目的是评估 COB-MS 对 MS 患者的可行性和初步疗效。重点是可行性结果以及与认知困难相关的功能以及与认知、疲劳和生活质量相关的次要结果。120 名 MS 患者将被分配参加 COB-MS 计划或照常治疗的候补名单对照组，作为 COB 的单盲、整群随机对照可行性和初步疗效试验的一部分-MS 程序。COB-MS 小组将参加为期 9 周、为期八节的基于职业的认知康复计划。主要结果指标是 12 周时的目标实现量表。参与者将在干预前、干预后以及干预后 12 周和干预后 6 个月时接受评估。作为可行性研究的一部分，还将对参与者的观点进行定性评估。结果将为 COB-MS 的未来最终试验提供建议，包括可行性和初步临床疗效。如果结果表明有效，研究结果将表明 COB-MS 需要考虑作为增强 MS 患者认知和日常功能的一种手段。ISRCTN：ISRCTN11462710。2019 年 9 月 9 日注册。研究结果表明，需要考虑将 COB-MS 作为增强 MS 患者认知和日常功能的一种手段。ISRCTN：ISRCTN11462710。2019 年 9 月 9 日注册。研究结果表明，需要考虑将 COB-MS 作为增强 MS 患者认知和日常功能的一种手段。ISRCTN：ISRCTN11462710。2019 年 9 月 9 日注册。