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

• Published in: Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 678
• Main Authors: Celleri, Milagros, Cremades, Camila F, Etchevers, Martin J, Garay, Cristian J
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 19-10-2023; BioMed Central; BMC
• Subjects: Anxiety disorders; Anxiety Disorders - therapy; Argentina; Bipolar disorder; Care and treatment; Clinical Protocols; Clinical trials; Comorbidity; Cost benefit analysis; COVID-19 - therapy; Emotional disorders; Emotions; Evidence-based medicine; Group counseling; Group therapy; Humans; Informed consent; Intervention; Laws, regulations and rules; Medical research; Medicine, Experimental; Mental illness; Mindfulness; Online; Psychotherapy; Quality of Life; Randomized Controlled Trials as Topic; Study Protocol; Telemedicine; Testing; Treatment Outcome; Unified Protocol; Argentina; Argentina; Emotional disorders; Group therapy; Unified Protocol; Online
• ISSN: 1745-6215; 1745-6215
• 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.