Facultad de Psicología, Universidad de Buenos Aires, Buenos Aires, Argentina.
Trials. 2023 Oct 19;24(1):678. doi: 10.1186/s13063-023-07428-4.
The Unified Protocol (UP) is a transdiagnostic intervention based on emotional regulation for the treatment of emotional disorders. Its application in individual and group formats has been studied worldwide, obtaining similar results to specific protocols but with a lower drop-out rate and improving the cost-benefit ratio, since a larger number of patients can benefit from it. Moreover, the inclusion of digital technologies in psychotherapy aims to improve the accessibility of treatments, especially since the pandemic of COVID-19 that forced the implementation of treatments through teletherapy increasing its use. To date, no studies have been carried out in Argentina on the application of the UP in a group format and through teletherapy. The aim of the present study is to evaluate the efficacy of the UP in a group format and through teletherapy in the Argentine population.
A parallel-group, controlled, randomized trial, with pre-post and repeated follow-up measures intergroup design will be conducted. One hundred eighty patients will be randomized to one of the following conditions: an online, group-based UP intervention or a waiting list. The Beck Depression Inventory-II and the Beck Anxiety Inventory will be used to compare primary outcomes and the Beck Hopelessness Scale, Difficulties in Emotion Regulation Scale, Positive Affect and Negative Affect Scale, and Multicultural Quality of Life Index will be administered for secondary outcomes at baseline, post-intervention, and 3 months follow-up. Ad-hoc questionnaires will be used to assess patients' experiences and treatment satisfaction.
The purpose of this trial is to evaluate the efficacy of the online and group application of the UP in the Argentine population, as well as to evaluate the patient's experience and satisfaction with the treatment. It is expected that the findings of this study will be useful in reducing anxious and depressive symptomatology, will allow us to adapt the UP to our culture, and will improve accessibility to treatment.
ClinicalTrials.gov NCT05275322. Registered on 11 March 2022.
统一方案（UP）是一种基于情绪调节的跨诊断干预措施，用于治疗情绪障碍。它在个体和团体形式中的应用已在全球范围内进行了研究，与特定方案相比，其结果相似，但脱落率更低，提高了成本效益，因为更多的患者可以从中受益。此外，将数字技术纳入心理治疗旨在提高治疗的可及性，特别是自 COVID-19 大流行以来，远程治疗迫使治疗方式的实施增加了其使用率。迄今为止，阿根廷尚未开展关于 UP 在团体形式和通过远程治疗中的应用的研究。本研究旨在评估 UP 在阿根廷人群中的团体形式和通过远程治疗的疗效。
将进行一项平行组、对照、随机试验，采用组间前后和重复随访设计。将 180 名患者随机分为以下两种情况之一：在线、基于团体的 UP 干预或等待名单。将使用贝克抑郁量表-II 和贝克焦虑量表来比较主要结果，在基线、干预后和 3 个月随访时使用贝克绝望量表、情绪调节困难量表、积极和消极情绪量表以及多元文化生活质量指数来评估次要结果。将使用专门的问卷评估患者的体验和治疗满意度。
本试验的目的是评估 UP 的在线和团体应用在阿根廷人群中的疗效，以及评估患者对治疗的体验和满意度。预计该研究的结果将有助于减轻焦虑和抑郁症状，使我们能够适应当地文化，提高治疗的可及性。
ClinicalTrials.gov NCT05275322。于 2022 年 3 月 11 日注册。
