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.

项目概要/摘要 据认为 50-75% 的多发性硬化症患者会出现多发性硬化症 (MS) 对认知的影响， 作为该疾病的主要致残症状之一，人们越来越认识到这一点。虽然大量研究 已经解决了多发性硬化症的情感和身体影响，但很少有人关注以下策略： 可能有助于管理多发性硬化症患者通常经历的认知变化。拟议的研究将 测试一种新型计算机辅助认知康复干预措施 MAPSS-MS（记忆、注意力和问题） 多发性硬化症患者的解决技能）。 MAPSS-MS 整合了团体干预的强大效果 通过个人家用计算机建立新的认知补偿策略/行为的自我效能感 认知技能的辅助练习。计算机培训将帮助个人发展认知技能 他们可以利用课堂上学到的补偿策略应用到日常生活中。在我们最近 完成了 61 名 MS 患者的探索性研究 (R21NR011076)，即为期八周的 MAPSS-MS 干预是可以接受和可行的，并且对补偿性药物的使用有中等到大的影响。 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 通过跨多个站点的更大、更多样化的样本 (N=180) 进行精细的 MAPSS-MS 干预，扩展了 干预后随访 6 个月，并确定绩效是否有所改善 神经心理学测试对于改善日常生活中的神经认知功能具有重要意义。 本研究的具体目的是：（1）评估MAPSS-MS认知康复的效果 改善多发性硬化症患者日常生活活动的整体神经认知能力的干预措施， 包括言语记忆表现、补偿性认知策略的使用以及 与认知相关的日常生活工具性活动（IADL）； (2) 评估MAPSS-MS的功效 提高自我效能和认知表现相关方面的干预（非语言 学习/记忆、信息处理速度和注意力、言语流畅性和复杂扫描和 追踪）多发性硬化症患者； (3) 确定达到以下目标的干预参与者数量： 在干预后的三个月和六个月内维持他们自我确定的认知目标。的影响 将使用随机对照试验设计来评估对结果变量的干预 对照组接受常规护理电脑游戏。研究变量的测量将发生在 基线、MAPSS-MS 干预后立即以及干预后三个月和六个月 干预完成。统计分析将包括描述性统计和 HLM 分析以解释 嵌套设计。将使用意向治疗方法。