Barbeito Sara, Vega Patricia, Ruiz de Azua Sonia, Balanza-Martinez Vicent, Colom Francesc, Lorente Esther, Luengo Ana, Cerrillo Ester, Crespo José Manuel, González Pinto Ana
Biomedical Research Centre in Mental Health Net (CIBERSAM), University Hospital of Álava (Santiago Apóstol), Osakidetza, Olaguibel Street, Vitoria, Spain.
Trials. 2014 Oct 27;15:416. doi: 10.1186/1745-6215-15-416.
The integrated treatment of first episode psychosis has been shown to improve functionality and negative symptoms in previous studies. In this paper, we describe a study of integrated treatment (individual psychoeducation complementary to pharmacotherapy) versus treatment as usual, comparing results at baseline with those at 6-month re-assessment (at the end of the study) for these patients, and online training of professionals to provide this complementary treatment, with the following objectives: 1) to compare the efficacy of individual psychoeducation as add-on treatment versus treatment as usual in improving psychotic and mood symptoms; 2) to compare adherence to medication, functioning, insight, social response, quality of life, and brain-derived neurotrophic factor, between both groups; and 3) to analyse the efficacy of online training of psychotherapists.
METHODS/DESIGN: This is a single-blind randomised clinical trial including patients with first episode psychosis from hospitals across Spain, randomly assigned to either a control group with pharmacotherapy and regular sessions with their psychiatrist (treatment as usual) or an intervention group with integrated care including treatment as usual plus a psychoeducational intervention (14 sessions). Training for professionals involved at each participating centre was provided by the coordinating centre (University Hospital of Álava) through video conferences. Patients are evaluated with an extensive battery of tests assessing clinical and sociodemographic characteristics (Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Liebowitz Social Anxiety Scale, Hamilton Rating Scale for Depression, Scale to Assess Unawareness of Mental Disorders, Strauss and Carpenter Prognostic Scale, Global Assessment of Functioning Scale, Morisky Green Adherence Scale, Functioning Assessment Short Test, World Health Organization Quality of Life instrument WHOQOL-BREF (an abbreviated version of the WHOQOL-100), and EuroQoL questionnaire), and brain-derived neurotrophic factor levels are measured in peripheral blood at baseline and at 6 months. The statistical analysis, including bivariate analysis, linear and logistic regression models, will be performed using SPSS.
This is an innovative study that includes the assessment of an integrated intervention for patients with first episode psychosis provided by professionals who are trained online, potentially making it possible to offer the intervention to more patients.
NCT01783457 clinical trials.gov. Date of registration in primary registry 23 January 2013.
既往研究表明，首发精神病的综合治疗可改善功能及阴性症状。在本文中，我们描述了一项综合治疗（药物治疗辅以个体心理教育）与常规治疗的对比研究，比较这些患者在基线时与6个月重新评估（研究结束时）的结果，以及专业人员在线培训以提供这种辅助治疗的情况，其目标如下：1）比较个体心理教育作为附加治疗与常规治疗在改善精神病性症状和情绪症状方面的疗效；2）比较两组之间的药物依从性、功能、自知力、社交反应、生活质量及脑源性神经营养因子水平；3）分析心理治疗师在线培训的效果。
方法/设计：这是一项单盲随机临床试验，纳入了来自西班牙各地医院的首发精神病患者，随机分配至对照组（接受药物治疗并定期与精神科医生会诊，即常规治疗）或干预组（接受综合治疗，包括常规治疗加心理教育干预，共14次疗程）。各参与中心的相关专业人员培训由协调中心（阿拉瓦大学医院）通过视频会议提供。患者通过一系列广泛的测试进行评估，这些测试评估临床和社会人口学特征（阳性与阴性症状量表、状态-特质焦虑量表、莱博维茨社交焦虑量表、汉密尔顿抑郁量表、精神障碍自知力评估量表、施特劳斯和卡彭特预后量表、总体功能评估量表、莫利斯基-格林依从性量表、功能评估简短测试、世界卫生组织生活质量量表WHOQOL-BREF（WHOQOL-100的简版）及欧洲五维度健康量表问卷），并在基线和6个月时测量外周血中的脑源性神经营养因子水平。统计分析，包括双变量分析、线性和逻辑回归模型，将使用SPSS进行。
这是一项创新性研究，包括对由在线培训的专业人员为首发精神病患者提供的综合干预进行评估，这有可能使更多患者能够接受该干预。
NCT01783457，clinicaltrials.gov。在主要注册机构的注册日期为2013年1月23日。
