WRITTEN-HEART 研究（表达性写作促进心脏康复）：一项针对接受住院心脏康复治疗的冠心病患者的表达性写作随机对照临床试验的原理和设计。
The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation.
机构信息
Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy.
出版信息
Health Qual Life Outcomes. 2011 Jul 8;9:51. doi: 10.1186/1477-7525-9-51.
BACKGROUND
Coronary heart disease (CHD) is typically associated with many cardiovascular risk factors (e.g., elevated blood pressure), low health-related quality of life, depression, anxiety and psychological stress. Expressive writing (EW) has shown beneficial effects on such variables in both people from the community and in patients with a variety of chronic illnesses. However, no study to date has evaluated the physical and psychological effects of the expressive writing procedure on coronary patients referred to cardiac rehabilitation (CR).
METHODS
The clinical effectiveness of a 2-week disease-related expressive writing procedure (writing about one's deepest thoughts and feelings regarding the experience with heart disease) compared with the standard writing task (writing about one's deepest thoughts and feelings about the most traumatic or negative event experienced in the life), a neutral writing condition (writing about the facts regarding heart disease and its treatment) and an empty control condition will be evaluated in a randomized controlled clinical trial (RCT) with repeated follow-up measurements at 3, 6 and 12 months after discharge from CR. The primary outcome is health-related quality of life (SF-12). Secondary outcome measures are depression (BDI-II), anxiety (BAI) and post-traumatic growth (PTGI). Furthermore, the study will explore the moderating effects of coping styles, type D personality, perceived emotional support and participants' evaluative ratings of the writing interventions on the main experimental effects in order to identify sub-groups of patients showing different results.
DISCUSSION
The WRITTEN-HEART study aims to explore and expand the frontiers of the expressive writing research enterprise by investigating the feasibility, safety and clinical efficacy of brief and cost-effective expressive writing interventions in patients with CHD referred to CR.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01253486.
背景
冠心病（CHD）通常与许多心血管危险因素（如血压升高）、较低的健康相关生活质量、抑郁、焦虑和心理压力有关。表达性写作（EW）已显示出对社区人群和各种慢性疾病患者的这些变量有益的影响。然而，迄今为止，没有研究评估表达性写作程序对被转介到心脏康复（CR）的冠心病患者的身体和心理影响。
方法
将为期 2 周的与疾病相关的表达性写作程序（撰写关于对心脏病体验的最深切的想法和感受）与标准写作任务（撰写关于一生中经历的最创伤或最负面的事件的最深切的想法和感受）、中性写作条件（撰写有关心脏病及其治疗的事实）和空白对照条件进行比较，将在一项随机对照临床试验（RCT）中评估其临床效果，在从 CR 出院后 3、6 和 12 个月进行重复随访测量。主要结果是健康相关生活质量（SF-12）。次要结果指标是抑郁（BDI-II）、焦虑（BAI）和创伤后成长（PTGI）。此外，该研究将探索应对方式、D 型人格、感知情感支持和参与者对写作干预的评价对主要实验效果的调节作用，以确定表现出不同结果的患者亚组。
讨论
WRITTEN-HEART 研究旨在通过调查简短且具有成本效益的表达性写作干预措施对被转介到 CR 的 CHD 患者的可行性、安全性和临床疗效，探索和扩展表达性写作研究的前沿。
试验注册
ClinicalTrials.gov NCT01253486。
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