Centro de Salud Dr Mendiguchia, Leganés, Madrid, Spain.
BMC Fam Pract. 2012 May 2;13:35. doi: 10.1186/1471-2296-13-35.
Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.
METHODS/DESIGN: This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.
This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.
The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].
在初级保健中，无法用医学解释的症状是一个重要的心理健康问题，在卫生服务中造成了很高的成本。认知行为疗法和心理动力学疗法已被证明对这些患者有效。然而，初级保健的心理社会干预的有效性研究很少。该项目旨在确定对患有无法用医学解释的症状的患者进行认知行为小组干预是否比常规临床实践更有效，以改善 SF-12 问卷在 12 个月时测量的生活质量。
方法/设计：这是一项在马德里（西班牙）的初级保健中心进行的基于社区的集群随机试验。需要的患者人数为 242 人（每组 121 人），所有患者年龄在 18 至 65 岁之间，在过去一年中至少因无法用医学解释的症状在初级保健中寻求过 10 次以上的医疗服务。主要结局变量是 SF-12 问卷对心理健康护理的生活质量测量。次要结局变量包括咨询次数、药物（处方）数量和病假天数以及其他预后和描述性变量。主要疗效将通过比较干预组和对照组在 12 个月时 SF-12 问卷改善至少 4 分的患者百分比来分析。所有统计检验均采用意向治疗进行。将使用具有随机效应的逻辑回归来调整预后因素。在分析中，将考虑混杂因素或可能改变记录效果的因素。
本研究旨在从定量方法为解决初级保健中高度普遍存在的无法用医学解释的症状提供更多的见解。它涉及由经过培训的护理人员进行的干预组，以减少症状的慢性化进展、提高生活质量和减少医疗咨询的频率。
该试验在 ClinicalTrials.gov 注册，编号为 NCT01484223 [http://ClinicalTrials.gov]。
