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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial

机译:基于互联网的跨诊断疗法治疗情绪障碍的疗效,具有解决积极影响的特定成分:随机对照试验的研究方案

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BackgroundEmotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internet-based treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients’ acceptance) of using a self-applied Internet-based program. This paper presents the study protocol.MethodsThe study is a randomized controlled trial. 207 participants will be randomly assigned to: a)Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants’ treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month follow-ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed.DiscussionTo the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED.Trial registrationClinicalTrial.gov: NCT02578758. Registered 15 October 2015.
机译:背景情绪障碍(ED)是最普遍的精神障碍之一。但是,只有不到50%的ED患者得到了适当的治疗。这种情况导致基于透诊断的观点提出了新的干预建议,试图解决急诊科常见的潜在过程。这些程序大多数主要集中在下调负面情感上,而不是增加力量和上调积极情感上。数据表明在这些疾病中存在积极情感障碍,因此迫切需要针对这些问题的新干预措施。向所有需要帮助的人提供帮助也很重要。信息和通信技术可能非常有用。这项研究旨在评估社区样本中基于ED的经互联网诊断的治疗的功效。该协议包括传统的CBT组件,以及解决积极影响的特定组件。我们打算与等待列表控制组一起测试此协议,包括或不包括此特定组件。此外,我们旨在测试该特定组件的差异效果,并研究使用基于互联网的自我应用程序的有效性(就患者的接受度而言)。本文介绍了研究方案。方法研究是一项随机对照试验。 207名参与者将被随机分配到:a)基于Internet的跨诊断协议(TIBP),b)基于Internet的跨诊断协议+积极影响成分(TIBP + PA),或c)等候名单对照组(WL)。主要结果指标将是BDI-II,BAI和PANAS。次要结果将包括针对特定疾病的特定诊断措施。参与者的治疗接受度也将进行衡量。将在治疗前,治疗后以及3个月和12个月的随访中对参与者进行评估。将根据意向性处理原则分析数据。根据协议的规定,还将进行分析。讨论据我们所知,这是对基于互联网的ED治疗进行首次诊断的研究,该治疗具有上调积极情感的特定成分。这项干预措施可能有助于提高当前ED治疗计划的效率和效力,促进EBT的传播,并有助于降低ED的高流行。试验注册ClinicalTrial.gov:NCT02578758。 2015年10月15日注册。

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