A Multi-Site Trial of a Cognitive Rehabilitation Intervention for Persons with MS

针对多发性硬化症患者的认知康复干预的多中心试验

• 批准号: 8744642
• 负责人: HEATHER A BECKER
• 金额: $ 45.42万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-27 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8744642
• 关键词: Accounting; Activities of Daily Living; Address; Affect; Attention; Axon; Behavior; Cells; Central Nervous System Diseases; Clinical Trials Design; Cognition; Cognitive; Cognitive deficits; Competence; Complex; Computer Assisted; Computers; Disease; Emotional; Family; Goals; Health; Home environment; Immune system; Impairment; Individual; Intervention; Knowledge; Learning; Life; Measurement; Memory; Multiple Sclerosis; Myelin; NIH Program Announcements; Neuraxis; Neurocognitive; Neuropsychological Tests; Outcome; Participant; Performance; Persons; Problem Solving; Quality of life; Randomized; Randomized Controlled Trials; Research; Research Personnel; Sampling; Scanning; Self Efficacy; Site; Societies; Symptoms; Testing; Training; Translating; United States; Work; base; cognitive change; cognitive function; cognitive rehabilitation; comparison group; design; effective intervention; experience; follow-up; group intervention; improved; information processing; innovation; instrumental activity of daily living; intervention effect; multi-site trial; neuropsychological; novel; post intervention; processing speed; public health relevance; response; skills; social; statistics; treatment as usual

DESCRIPTION (provided by applicant): The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons with MS, have gained increasing recognition as one of the major disabling symptoms of the disease. While numerous studies have addressed the emotional and physical impact of MS, little attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. The proposed study will test a novel computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, & Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of group interventions to build self-efficacy for new cognitive compensatory strategies/behaviors with individual home-based computer- assisted practice of cognitive skills. The computer training will assist individuals to develop cognitive skills that they can apply to everyday life using the compensatory strategies learned in the class sessions. In our recently completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS intervention was acceptable and feasible and had medium to large effects on the use of compensatory strategies and performance on neuropsychological tests of verbal memory. The proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months and establish whether performance improvements on neuropsychological tests make the important transfer to improved neurocognitive functioning in everyday life. The specific aims of this study are to: (1) Evaluate the efficacy of the MAPSS-MS cognitive rehabilitation intervention in improving overall neurocognitive competence of persons with MS in activities of daily living, including verbal memory performance, use of compensatory cognitive strategies, and performance on cognitive-related instrumental activities of daily living (IADL); (2) Evaluate the efficacy of the MAPSS-MS intervention in improving self-efficacy and related aspects of cognitive performance (non-verbal learning/memory, information processing speed and attention, verbal fluency and complex scanning and tracking) among persons with MS; and (3) Determine the number of intervention participants who achieve and maintain their self-identified cognitive goals at three and six months following the intervention. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care computer games. Measurements of study variables will occur at baseline, immediately after the MAPSS-MS intervention, and three months and six months after the intervention is complete. Statistical analysis will include descriptive statistics and HLM analysis to account for the nested design. The intent-to-treat approach will be used.

描述（由申请人提供）：多发性硬化症（MS）对认知的影响，被认为发生在50-75％的MS患者中，作为该疾病的主要残疾症状之一，人们越来越认识到越来越多的识别。尽管许多研究已经解决了MS的情绪和身体影响，但很少关注可能有助于管理MS患者通常经历的认知变化的策略。拟议的研究将测试一种新型的计算机辅助认知康复干预，MAPSS-MS（记忆，注意力和MS患者解决问题的技能）。 MAPSS-MS将小组干预措施的强大效果与新认知补偿策略/行为建立自我效能的强大影响与个人基于家庭的计算机辅助认知能力实践。计算机培训将帮助个人发展认知技能，可以使用班级课程中学到的补偿策略应用于日常生活。在我们最近完成的61名MS（R21NR011076）的探索性研究中，为期八周的MAPSS-MS干预是可以接受且可行的，并且对使用补偿性策略和对言语记忆的神经心理测验的使用具有中等至重要的影响。拟议的研究将测试精致的MAPS-MS干预措施，跨多个地点更大的样本（n = 180），将干预后随访的期限延长到6个月，并确定对神经心理学测试的绩效提高是否使得在日常生活中改善神经认知功能的重要转移。这项研究的具体目的是：（1）评估MAPS-MS认知康复干预措施在改善日常生活活动中具有MS的人的整体神经认知能力，包括语言记忆表现，使用补偿性认知策略以及对日常生活的认知相关工具活动（IADIADL）； （2）评估MAPS-MS干预措施在改善认知表现的自我效能感和相关方面（非语言学习/记忆，信息处理速度和注意力，口头流畅性以及复杂的扫描和跟踪）的功效； （3）确定干预后三和六个月实现和维持其自我认同的认知目标的干预参与者的数量。干预的影响 结果变量将使用随机对照试验设计进行评估，并通过比较组接收平常的护理计算机游戏。研究变量的测量将在基线，MAPS-MS干预后立即进行，干预完成后三个月零六个月。统计分析将包括描述性统计 和HLM分析以说明嵌套设计。将使用意向性治疗方法。