Centre for Mental Health, Imperial College, UK.
BMC Psychiatry. 2011 Jun 14;11:99. doi: 10.1186/1471-244X-11-99.
Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT) in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population.
METHOD/DESIGN: The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out) to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years.
This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also whether the cost of treatment is offset by savings from reduced use of other health services in comparison to the control group.Cognitive behaviour therapy for Health Anxiety in Medical Patients (CHAMP) TRIAL REGISTRATION: Current Controlled Trials ISRCTN14565822.
异常健康焦虑,也称为疑病症,已通过认知行为疗法(CBT)在从初级保健招募的患者中成功治疗,但仅在二级医疗诊所进行了一项试点试验,在这些诊所中,健康焦虑可能更为常见,并对服务产生更大的影响。CHAMP 研究扩展了这项工作,以检查 CBT 在这一人群中的临床和成本效益。
方法/设计:该研究是一项随机对照试验,有两个平行组,将 466 名符合条件的患者(假设 20%的脱落率)随机分为积极治疗组(5-10 次认知行为疗法)和对照组。在基线时,即完成所有评估但在随机分组之前,目标是向所有参与者提供关于健康焦虑本质的标准简单解释。随后,对照组将接受诊所中通常可能提供的任何护理,通常是临床评估、适当的测试和保证的组合。分配到积极治疗组的患者计划接受基于 Salkovskis/Warwick 模型的适应性认知行为疗法,其中选择了一系列治疗策略,旨在帮助患者了解驱动和维持健康焦虑的因素。该疗法计划由研究生研究人员、护士或其他受过这种干预培训的卫生专业人员提供,在治疗过程中还将对他们的能力进行独立评估。主要结局是一年后健康焦虑症状的减少,主要次要结局是两年后护理的成本。
这是首次针对健康焦虑症的适应性认知行为疗法进行的试验,规模足够大,可以不仅检验治疗的临床效益,还可以检验与对照组相比,治疗成本是否可以通过减少对其他卫生服务的使用来抵消。
医疗患者健康焦虑认知行为疗法(CHAMP)试验注册:当前对照试验 ISRCTN69415129。