Effectiveness of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Online and Group format in Argentina: study protocol for a randomized controlled trial (preprint)

ABSTRACT

Background 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. Methods A parallel-group, controlled, randomized trial, with a pre-post and repeated follow-up measures intergroup design will be conducted. 180 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-doc questionnaires will be used to assess patients' experiences and treatment satisfaction. Discussion 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. Trial registration ClinicalTrials.gov ID NCT05275322 Registered on 11 March 2022,