Fleming Jennifer, Ownsworth Tamara, Doig Emmah, Hutton Lauren, Griffin Janelle, Kendall Melissa, Shum David H K
School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, 4072, QLD, Australia.
Occupational Therapy Department, Princess Alexandra Hospital, Brisbane, Australia.
Trials. 2017 Jan 5;18(1):3. doi: 10.1186/s13063-016-1758-6.
Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI.
METHODS/DESIGN: This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups.
This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies.
New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement.
创伤性脑损伤（TBI）后前瞻性记忆（PM）受损很常见，且对独立生活有负面影响。已发现针对PM康复的补偿方法可将TBI成年患者PM损伤的影响降至最低；然而，TBI后的自我意识差是补偿策略在日常生活中推广的主要障碍。元认知技能训练（MST）是一种认知康复方法，旨在促进TBI成年患者自我意识的发展。本文描述了一项研究方案，旨在评估MST方法对补偿性PM康复的疗效，以改善TBI后的日常PM表现和心理社会结局。
方法/设计：这项随机对照试验有三个治疗组：补偿训练加元认知技能训练（COMP-MST）、仅补偿训练（COMP）和等待名单对照组。COMP-MST组和COMP组的参与者将完成为期6周的干预，包括每周6次、每次2小时的训练课程。每次1.5小时的课程将包括补偿策略训练，0.5小时将纳入MST（COMP-MST组）或填充活动作为积极对照（COMP组）。等待名单组的参与者接受6周的常规护理，随后接受COMP-MST干预。根据样本量估计，90名中重度TBI患者将采用分层抽样方法随机分为三组。主要结局包括日常生活中PM表现的测量指标和心理社会重新融入水平。次要结局包括心理测量测试中PM功能的测量指标、策略使用、自我意识以及TBI后支持需求水平。将在干预前后以及3个月和6个月随访时进行盲法评估。
本研究旨在确定COMP-MST对改善和维持中重度TBI成年患者日常PM表现和心理社会融合水平的疗效。研究结果将推进对自我意识在补偿性PM康复和技能推广中作用的理论理解。COMP-MST有可能降低TBI后的康复和生活方式支持成本，因为该干预措施可提高PM补偿策略的推广成功率和终身应用率。
新西兰临床试验注册中心，ACTRN12615000996561。于2015年9月23日注册；开始2个月后追溯注册。
