针对复发缓解型多发性硬化且残疾程度较低患者的强化社会认知项目（“能做到”疗法）：一项随机对照试验方案
An intensive social cognitive program (can do treatment) in people with relapsing remitting multiple sclerosis and low disability: a randomized controlled trial protocol.
作者信息
Jongen Peter Joseph, Heerings Marco, Ruimschotel Rob, Hussaarts Astrid, Evers Silvia, Duyverman Lotte, Valkenburg-Vissers Joyce, Cornelissen Job, Bos Michel, van Droffelaar Maarten, Lemmens Wim A, Donders Rogier, van der Zande Anneke, Visser Leo H
机构信息
Department of Community & Occupational Medicine, University Medical Centre Groningen, Antonius Deusinglaan 1, 9713, AV, Groningen, The Netherlands.
MS4 Research Institute, Ubbergseweg 34, 6522, KJ, Nijmegen, The Netherlands.
出版信息
BMC Neurol. 2016 May 28;16:81. doi: 10.1186/s12883-016-0593-4.
BACKGROUND
In people with multiple sclerosis (MS) disabilities and limitations may negatively affect self-efficacy. Lowered self-efficacy has been associated with decreases in health-related quality of life, physical activity and cognitive performance. In an explorative observational study we found that a 3-day intensive social cognitive program (Can Do Treatment [CDT]) with the participation of support partners was followed by substantial increases in self-efficacy control and health-related quality of life 6 months after treatment in those people with MS who had relapsing remitting disease and low disability.
METHODS/DESIGN: CDT is a sociologically oriented approach, its goal is to uncover and promote existing capabilities, and the notion "stressor" is the central concept. CDT's components are plenary group sessions, small group sessions, consultations, a theatre evening, and start of the day with a joint activity. The small group sessions form the actual training. Depending on their individual goals the participants join the training groups 'Body', 'Feeling' or 'Life', to work out their aims and to reduce their stressors. The multidisciplinary team includes a psychiatrist, psychiatric nurse, neurologist, specialized MS nurse, physiotherapist, dance therapist, and a person with MS. To evaluate the (cost)effectiveness of CDT in persons with relapsing remitting MS and low disability we perform a single-centre, randomized controlled trial in 140 patients, with or without support partners. The primary outcome is self-efficacy control. The secondary outcomes are self-efficacy function, health-related quality of life, autonomy and participation, anxiety, depression, cost effectiveness and cost utility. The tertiary outcome is care-related strain to support partners. Outcomes are assessed at baseline and at 1, 3 and 6 months after CDT.
DISCUSSION
This randomized controlled trial will adequately evaluate the clinical and cost effectiveness of a 3-day intensive social cognitive program in people with relapsing remitting MS and low disability, with self-efficacy control as primary outcome.
DUTCH TRIAL REGISTRY
Application number: 22444.
背景
在多发性硬化症（MS）患者中，残疾和功能受限可能会对自我效能产生负面影响。自我效能降低与健康相关生活质量、身体活动及认知表现的下降有关。在一项探索性观察研究中，我们发现，对于复发缓解型疾病且残疾程度较低的MS患者，参加为期3天的强化社会认知项目（“我能行”治疗[CDT]）并在支持伙伴参与的情况下，治疗6个月后自我效能控制及健康相关生活质量大幅提高。
方法/设计：CDT是一种以社会学为导向的方法，其目标是发掘并提升现有能力，“压力源”这一概念是核心概念。CDT的组成部分包括全体会议、小组会议、咨询、戏剧之夜以及以联合活动开启一天。小组会议构成实际培训。参与者根据个人目标加入“身体”“感受”或“生活”培训小组，以明确目标并减轻压力源。多学科团队包括一名精神科医生、精神科护士、神经科医生、专业MS护士、物理治疗师、舞蹈治疗师以及一名MS患者。为评估CDT对复发缓解型MS且残疾程度较低患者的（成本）效果，我们对140名患者进行单中心随机对照试验，这些患者有无支持伙伴均可。主要结局是自我效能控制。次要结局包括自我效能功能、健康相关生活质量、自主性与参与度、焦虑、抑郁、成本效果及成本效用。三级结局是支持伙伴的护理相关压力。结局在基线时以及CDT后1、3和6个月进行评估。
讨论
这项随机对照试验将充分评估为期3天的强化社会认知项目对复发缓解型MS且残疾程度较低患者的临床及成本效果，以自我效能控制作为主要结局。
荷兰试验注册
注册号：22444。
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