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: 9079273
• 负责人: HEATHER A BECKER
• 金额: $ 43.87万
• 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/9079273
• 关键词: Accounting; Activities of Daily Living; Address; Affect; Attention; Axon; Behavior; Cells; Central Nervous System Diseases; 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; Statistical Data Interpretation; Symptoms; TP53 gene; Testing; Training; Translating; United States; Work; axon injury; base; cognitive change; cognitive function; cognitive performance; cognitive rehabilitation; cognitive skill; comparison group; computer game; design; disabling symptom; effective intervention; experience; follow-up; group intervention; improved; information processing; innovation; instrumental activity of daily living; intervention effect; learning strategy; multi-site trial; neuropsychological; novel; post intervention; processing speed; response; skills; social; statistics; treatment as usual; trial design

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(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，已经越来越多地被认为是这种疾病的主要致残症状之一。虽然许多研究都讨论了多发性硬化症对情绪和身体的影响，但很少有人关注可能有助于管理多发性硬化症患者普遍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(多发性硬化症患者的记忆、注意力和解决问题的技能)。MAPSS-MS将团体干预的强大效果与基于个人家庭的计算机辅助认知技能练习相结合，为新的认知补偿策略/行为建立自我效能。计算机培训将帮助个人发展认知技能，他们可以使用在课堂上学到的补偿策略应用于日常生活。在我们最近完成的对61名多发性硬化症患者(R21NR011076)的探索性研究中，为期8周的MAPSS-MS干预是可以接受和可行的，并在言语记忆的神经心理测试中对代偿策略的使用和表现产生了中等到很大的影响。这项拟议的研究将在多个地点用更大、更多样化的样本(N=180)测试改进的MAPSS-MS干预，将干预后的随访期延长至6个月，并确定神经心理测试的表现改善是否有助于改善日常生活中的神经认知功能。本研究的具体目的是：(1)评价MAPSS-MS认知康复干预对改善多发性硬化症患者日常生活活动中的整体神经认知能力的有效性，包括言语记忆能力、补偿性认知策略的使用和认知相关的日常生活工具活动(IADL)的表现；(2)评价MAPSS-MS干预对提高多发性硬化症患者的自我效能感及其相关认知表现(非言语学习/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)的有效性；以及(3)确定在干预后三个月和六个月达到并维持其自我确定的认知目标的干预参与者的数量。干预措施的效果 结果变量将使用随机对照试验设计进行评估，对照组接受常规护理电脑游戏。研究变量的测量将在基线、MAPSS-MS干预后立即以及干预完成后三个月和六个月进行。统计分析将包括描述性统计 和HLM分析，以说明嵌套设计。将使用意向治疗方法。