González-Ortega Itxaso, Ugarte Amaia, Ruiz de Azúa Sonia, Núñez Nuria, Zubia Marta, Ponce Sara, Casla Patricia, Llano Josu Xabier, Faria Ángel, González-Pinto Ana
Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
Centro de Investigación en Cronicidad-Kronikgune, Barakaldo, Spain.
BMC Psychiatry. 2016 Dec 22;16(1):452. doi: 10.1186/s12888-016-1159-0.
Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used.
This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment.
This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients.
NCT02924415 . Retrospectively registered 27 September 2016.
双相情感障碍患者经常出现复发发作，且常伴有亚综合征症状、认知障碍和功能障碍，生活质量低下，疾病复发且反复住院。早期诊断和适当干预可能有助于预防该疾病的神经进展。新技术为利用基于互联网的工具开发标准化心理治疗提供了契机，这些工具克服了面对面治疗的一些局限性，因为它们易于获取，治疗时间可根据用户需求和可用性进行调整。然而，尽管通过网络和移动设备为双相情感障碍提供了许多心理治疗方案，但由于所采用的测量方法和方法论差异很大，缺乏关于其疗效和有效性的高质量证据。
本临床试验是一项欧洲项目中的单盲随机试验，旨在比较基于互联网的干预与常规治疗。纳入双相情感障碍患者并随机分为两组：1）实验组（远程护理支持）和2）对照组。两组参与者将在基线（治疗前）和治疗后进行评估。
本研究描述了一项基于心理教育干预的临床试验设计，该设计可能对双相情感障碍的预后和治疗产生重大影响。具体而言，通过整合不同服务（服务聚合），希望所提出的方法将显著提高信息通信技术对治疗可及性和依从性、服务质量、患者安全、患者和专业人员满意度以及患者生活质量的影响。
NCT02924415。于2016年9月27日进行回顾性注册。
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