Centre for Mental Health, Imperial College, Claybrook Road, London, W6 8LN, UK.
Centre for Mental Health, Imperial College, 7th Floor, Commonwealth Building, Hammersmith Hospital, London, W12 0NN, UK.
BMC Psychol. 2015 Nov 24;3:41. doi: 10.1186/s40359-015-0099-7.
Most patients with chest pain have nothing wrong with their cardiac function. Psychological forms of treatment for this condition are more likely to be successful than others.
METHODS/DESIGN: A two-arm parallel controlled randomized trial of standard care versus a modified form of cognitive behaviour therapy for chest pain (CBT-CP) in patients who have attended emergency hospital services. Inclusion criteria include (i) emergency attendance more than once in the previous year with chest pain when no physical pathology has been found, (ii) aged between 16 and 75, (iii) signed consent to take part in the study. Exclusion criteria are (i) under current psychiatric care, (ii) those who have had new psychotropic drugs prescribed within the last two months, (iii) are receiving or about to receive a formal psychological treatment. Those satisfying these criteria will be randomized to 4-10 sessions of CBT-CP or to continue with standard care. Participants are randomized using a remote web-based system using permuted stacked blocks stratified by study centre. Assessment is carried out at baseline by researchers subsequently masked to allocation and at 6 months and 1 year after randomization. The primary outcome is the Health Anxiety Inventory score at 6 months, and secondary outcomes are generalised anxiety and depressive symptoms, the Lucock Health Anxiety Questionnaire adapted for chest pain, visual analogue scales for chest pain and discomfort (Inskip Scale), the Schedule for Evaluating Persistent Symptoms (SEPS), health related quality of life, social functioning and medical resource usage. Intention to treat analyses will be carried out with clinical and functioning data, and a cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The data will also be linked to another parallel study in New Zealand where 126 patients with the same inclusion criteria have been treated in a similar trial; the form of analysis of the combined data has yet to be determined.
The morbidity and costs of non-cardiac chest pain are substantial and if a simple psychological treatment given by health professionals working in medical departments is beneficial it should prove to be of great value. Combining data with a similar study in New Zealand is an additional asset.
ISRCTN14711101 (registered 05/03/2015).
大多数胸痛患者的心脏功能并无异常。相较于其他治疗方法，针对此类病症的心理治疗形式更有可能取得成功。
方法/设计：一项关于标准护理与改良认知行为疗法（CBT-CP）治疗胸痛（CP）的双臂平行对照随机试验，该试验纳入了曾因胸痛而前往急诊医院就诊、但并未发现器质性病变的患者。纳入标准包括：（i）过去一年中因胸痛急诊就诊次数≥1 次；（ii）年龄 16-75 岁；（iii）签署参加研究的同意书。排除标准为：（i）正在接受精神科治疗；（ii）过去两个月内被开处新的精神药物；（iii）正在接受或即将接受正式的心理治疗。符合上述标准的患者将被随机分配至 4-10 次 CBT-CP 治疗或继续接受标准护理。参与者使用基于网络的远程系统进行随机分组，分组方式为基于研究中心的随机分层堆积块。研究者在基线时进行评估，随后对分配情况进行设盲，并在随机分组后 6 个月和 1 年时进行评估。主要结局指标为 6 个月时的健康焦虑量表（HAI）评分，次要结局指标包括广泛性焦虑和抑郁症状、改良胸痛版 Lucock 健康焦虑问卷、胸痛和不适的视觉模拟量表（Inskip 量表）、持续症状评估量表（SEPS）、健康相关生活质量、社会功能和医疗资源使用情况。将对意向治疗人群进行临床和功能数据的分析，同时使用 EQ-5D 得出的 QALYs 比较总成本和生活质量差异的效用分析。此外，还将对纳入标准相同的 126 例患者进行的新西兰平行研究的数据进行关联分析；目前尚未确定联合数据分析的形式。
非心源性胸痛的发病率和医疗费用相当高，如果一种由在医疗部门工作的健康专业人员提供的简单心理治疗方法有益，那么它将具有巨大的价值。与新西兰的一项类似研究进行数据合并是一个额外的优势。
ISRCTN80646138（于 2015 年 3 月 5 日注册）。
