Co-development of a protocol for a randomised controlled feasibility trial of CIRCuiTS™ cognitive remediation therapy for people with multiple sclerosis.
Rebecca J Thomas, Matteo Cella, Peter A Brex, Eli Silber, Kate Fifield, Patrick Burke, Mary Summers, Sara Simblett, Til Wykes
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引用次数: 0
Abstract
Background: Cognitive difficulties are common in people with multiple sclerosis (MS) and predict poorer quality of life, yet effective treatment is lacking. Cognitive remediation therapy (CRT) improves functioning in individuals with severe mental health conditions and could benefit people with MS if adequately adapted. Recognising patient and public involvement (PPI) benefits in developing acceptable interventions, this study engaged people with MS to develop a protocol to assess the feasibility of delivering a computerised, therapist-assisted CRT programme (CIRCuiTS™) to people with MS. This paper describes this process and presents the trial protocol, highlighting how PPI informed the study design and treatment implementation.
Methods: Protocol co-development involved three phases of consultation with people with MS. First, the PPI lead, who has MS, contributed along with mental health professionals to the design draft. Second, co-development using an observational qualitative design was conducted with people with MS in a structured 2-day workshop. Workshop discussions were recorded, transcribed, and analysed thematically to arrive at 24 specific, actionable recommendations. These recommendations, alongside statistical input, guided the trial design. Finally, a separate PPI group provided feedback on the trial documents. The proposed trial will recruit 24 people with MS experiencing cognitive difficulties from a UK NHS service, randomly assigning them to receive a 12-week CIRCuiTS™ MS programme immediately or after a 13-week wait. This relatively short waiting period was recommended as likely to maintain engagement. Standard CIRCuiTS™ delivery will be adapted to MS needs by offering remote sessions, dexterity tailoring and MS-specific therapist training. Primary outcomes are feasibility and acceptability. Guided by PPI-anticipated benefits, the secondary outcomes will be goal attainment, cognition, fatigue, mood, and daily functioning. Two people with MS continue to guide the study in the oversight group and a PPI Advisory group will provide ongoing advice on trial management.
Discussion: PPI, as recommended in the new CONSORT 2025 statement, strengthened the feasibility and acceptability of the trial by addressing challenges and shaping the protocol. This collaboration enhances the evaluation of CRT for people with MS and provides a model for transparent PPI reporting in trial development.
Trial registration: ClinicalTrials.gov ID NCT06877273, 14th March 2025.
背景：认知困难在多发性硬化症（MS）患者中很常见，预示着较差的生活质量，但缺乏有效的治疗方法。认知修复疗法（CRT）改善了严重精神健康状况患者的功能，如果适应得当，可能对多发性硬化症患者有益。认识到患者和公众参与（PPI）在开发可接受的干预措施方面的好处，本研究让多发性硬化症患者制定了一项协议，以评估向多发性硬化症患者提供计算机化、治疗师辅助的CRT计划（CIRCuiTS™）的可行性。本文描述了这一过程，并介绍了试验协议，强调了PPI如何影响研究设计和治疗实施。方法：方案的共同制定包括与多发性硬化症患者进行三个阶段的咨询。首先，患有多发性硬化症的PPI负责人与心理健康专业人员一起参与设计草案。其次，在为期2天的结构化研讨会中，采用观察性定性设计与多发性硬化症患者进行共同开发。对研讨会的讨论进行了记录、转录和专题分析，以得出24项具体的、可操作的建议。这些建议与统计输入一起指导了试验设计。最后，一个单独的PPI小组对试验文件提供反馈。拟议的试验将从英国NHS服务中招募24名患有认知困难的MS患者，随机分配他们立即接受12周的CIRCuiTS™MS项目，或在13周的等待后接受12周的MS项目。这种相对较短的等待时间可以保持玩家的粘性。标准电路™交付将通过提供远程会议，灵活性定制和MS特定的治疗师培训来适应MS的需求。主要结果是可行性和可接受性。在ppi预期益处的指导下，次要结果将是目标实现、认知、疲劳、情绪和日常功能。两名多发性硬化症患者继续在监督组指导研究，一个PPI咨询小组将为试验管理提供持续的建议。讨论：正如新的CONSORT 2025声明所建议的那样，PPI通过解决挑战和制定方案加强了试验的可行性和可接受性。这项合作加强了对MS患者CRT的评估，并为试验开发中透明的PPI报告提供了一个模型。试验注册：ClinicalTrials.gov ID NCT06877273, 2025年3月14日。
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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