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: 8643370
• 负责人: HEATHER A BECKER
• 金额: $ 47.16万
• 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/8643370
• 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

PROJECT SUMMARY / ABSTRACT 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 neuro-cognitive 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 neuro-cognitive 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.

项目摘要 /摘要 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，人们获得了越来越多的认可。而许多研究 已经解决了MS的情感和身体影响，对策略几乎没有关注 可能有助于管理MS患者常见的认知变化。拟议的研究将 测试一种新颖的计算机辅助认知康复干预，MAPSS-MS（记忆，注意力和问题 为MS的人解决技能）。 MAPSS-MS将小组干预的强大影响整合到 通过基于家庭的计算机来建立新认知补偿策略/行为的自我效能感 - 认知技能的辅助实践。计算机培训将帮助个人发展认知技能 他们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 与61名MS（R21NR011076）的人完成的探索性研究，为期八周的MAPSS-MS 干预是可以接受且可行的，并且对使用补偿性有中等至大影响 言语记忆神经心理学测试的策略和表现。拟议的研究将测试 精制的MAPS-MS干预措施，跨多个站点更大的样本（n = 180），扩展 干预后的随访期间，直到6个月，并确定绩效是否改善 神经心理学测试使重要的转移到日常生活中改善神经认知功能。 这项研究的具体目的是：（1）评估MAPSS-MS认知康复的功效 在日常生活活动中改善MS患者的整体神经认知能力的干预措施， 包括口头记忆表现，使用补偿性认知策略以及在 与认知相关的日常生活（IADL）的工具活动； （2）评估MAPSS-MS的功效 干预改善自我效能感和认知表现相关方面（非语言 学习/记忆，信息处理速度和注意力，口头流利度和复杂的扫描和 跟踪）在有MS的人中； （3）确定实现和 干预后的三个月和六个月，保持自己的认知目标。效果 将使用随机对照试验设计评估结果变量的干预措施 比较小组接收通常的护理计算机游戏。研究变量的测量将发生在 基线，在MAPSS-MS干预后立即 干预完成。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。