揭示创伤性脑损伤后疲劳和睡眠问题的生物心理社会因素：一项多中心纵向队列研究方案
Unraveling the Biopsychosocial Factors of Fatigue and Sleep Problems After Traumatic Brain Injury: Protocol for a Multicenter Longitudinal Cohort Study.
作者信息
Bruijel Jessica, Stapert Sven Z, Vermeeren Annemiek, Ponsford Jennie L, van Heugten Caroline M
机构信息
Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, Netherlands.
Limburg Brain Injury Centre, Maastricht, Netherlands.
出版信息
JMIR Res Protoc. 2018 Oct 22;7(10):e11295. doi: 10.2196/11295.
BACKGROUND
Fatigue and sleep problems are common after a traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory, and they can drastically impact the quality of life and societal participation of the patient and their family and friends. However, the etiology and development of these symptoms are still uncertain.
OBJECTIVE
The aim of this study is to examine the development of fatigue and sleep problems following moderate to severe TBI and to explore the changes in underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors across time.
METHODS
This study is a longitudinal multicenter observational cohort study with 4 measurement points (3, 6, 12, and 18 months postinjury) including subjective questionnaires and cognitive tasks, preceded by 7 nights of actigraphy combined with a sleep diary. Recruitment of 137 moderate to severe TBI patients presenting at emergency and neurology departments or rehabilitation centers across the Netherlands is anticipated. The evolution of fatigue and sleep problems following TBI and their association with possible underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors will be examined.
RESULTS
Recruitment of participants for this longitudinal cohort study started in October 2017, and the enrollment of participants is ongoing. The first results are expected at the end of 2020.
CONCLUSIONS
To the authors' knowledge, this is the first study that examines the development of both post-TBI fatigue and sleep longitudinally within a biopsychosocial model in moderate to severe TBI using both subjective and objective measures. Identification of modifiable factors such as mood and psychosocial stressors may give direction to the development of interventions for fatigue and sleep problems post-TBI.
TRIAL REGISTRATION
Netherlands Trial Register NTR7162; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162 (Archived by WebCite at http://www.webcitation.org/6z3mvNLuy).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/11295.
背景
创伤性脑损伤（TBI）后疲劳和睡眠问题很常见，是令人极度痛苦的症状，在恢复过程中起重要作用，会严重影响患者及其家人和朋友的生活质量和社会参与度。然而，这些症状的病因和发展仍不确定。
目的
本研究旨在探讨中度至重度TBI后疲劳和睡眠问题的发展，并探究潜在的生物学（疼痛、脑损伤）、心理（情绪状态）和社会（家庭支持、参与度）因素随时间的变化。
方法
本研究是一项纵向多中心观察性队列研究，有4个测量点（受伤后3、6、12和18个月），包括主观问卷和认知任务，在此之前有7晚的活动记录仪监测并结合睡眠日记。预计招募137名在荷兰各急诊科、神经科或康复中心就诊的中度至重度TBI患者。将研究TBI后疲劳和睡眠问题的演变及其与潜在的生物学（疼痛、脑损伤）、心理（情绪状态）和社会（家庭支持、参与度）因素的关联。
结果
这项纵向队列研究的参与者招募于2017年10月开始，目前仍在进行参与者招募。预计2020年底得出首批结果。
结论
据作者所知，这是第一项在中度至重度TBI的生物心理社会模型中，使用主观和客观测量方法纵向研究TBI后疲劳和睡眠发展的研究。识别如情绪和心理社会压力源等可改变因素，可能为TBI后疲劳和睡眠问题的干预措施发展提供方向。
试验注册
荷兰试验注册库NTR7162；http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162（由WebCite存档于http://www.webcitation.org/6z3mvNLuy）。
国际注册报告识别号（IRRID）：RR1-10.2196/11295。
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