Effectiveness of a blended group transdiagnostic treatment for emotional disorders: Study protocol for a randomized controlled trial.

Introduction: Emotional disorders (ED) (mood and anxiety disorders) are very prevalent and disabling, and often appear in comorbid presentations. Although there are effective treatments for these disorders, there is still a large gap between the number of people who need them and those who actually receive them. The combination of three strategies may help in this regard, facilitating the dissemination and accessibility of treatment: the transdiagnostic perspective of ED, the group format, and the use of technologies in a blended format (i.e., the combination of online and face-to-face therapy elements). This study intends to compare the efficacy of a new ED intervention, a transdiagnostic group treatment protocol administered in a blended format, with that of a face-to-face treatment. This article describes the study protocol for the randomized controlled trial.

Method And Analyses: A two-arm, parallel-group, randomized controlled clinical trial (RCT) will be conducted. Participants ( = 144) will be adult volunteers suffering from DSM-5 anxiety and/or depressive disorders and will be randomly assigned to one of two conditions: Face-to-face Group Transdiagnostic Protocol or Blended Group Transdiagnostic Protocol. The face-to-face condition will consist of a total of 16 weekly face-to-face group sessions, while the blended condition will consist of 8 biweekly face-to-face group sessions in combination with self-applied work through a web platform. Clinical and acceptability measures will be included in both groups. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-, 6- and 12-month follow-ups. This study received the approval of the Ethics Committee of Universitat Jaume I in October 2021 (CD/91/2021). Intention-to-treat analyses will be performed. Statistical analyses will be carried out using SPSS version 28.0. The results will be reported in accordance with CONSORT recommendations.

Discussion: This is the first RCT to compare the effectiveness of an ED treatment protocol based on the transdiagnostic perspective and applied in group and blended format. It will offer relevant data to continue moving forward towards treatment alternatives that are cost-effective and more accessible, so that all patients with ED who require them can benefit.

Trial Registration: ClinicalTrials.gov Identifier: NCT05569018. Registered 06 October 2022, https://clinicaltrials.gov/study/NCT05569018.