Implementation, efficacy and cost effectiveness of the unified protocol in a blended format for the transdiagnostic treatment of emotional disorders: a study protocol for a multicentre, randomised, superiority controlled trial in the Spanish National Health System

• Published in: BMJ open 2021-12, Vol.11 (12), p.e054286
• Main Authors: Osma, J, Martínez-García, Laura, Peris-Baquero, Óscar, Navarro-Haro, María Vicenta, González-Pérez, Alberto, Suso-Ribera, Carlos
• Format: Article
• Language: English
• Subjects: Anxiety disorders; Cognitive Behavioral Therapy - methods; Cost-Benefit Analysis; depression & mood disorders; Emotional disorders; Emotional regulation; Emotions; Feasibility studies; Health Care Costs; Humans; Intervention; Mental depression; Mental disorders; Mental health; Mood Disorders; Patients; Public Health; Quality of Life; Questionnaires; School dropouts; Smartphones; Treatment Outcome
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-054286

IntroductionEmotional disorders (EDs) have become the most prevalent psychological disorders in the general population, which has boosted the economic burden associated with their management. Approximately half of the individuals do not receive adequate treatment. Consequently, finding solutions to deliver cost-effective treatments for EDs has become a key goal of today’s clinical psychology. Blended treatments, a combination of face-to-face and online interventions, have emerged as a potential solution to the previous. The Unified Protocol for the Transdiagnostic Treatment of EDs (UP) might serve this purpose, as it can be applied to a variety of disorders simultaneously and its manualised format makes it suitable for blended interventions.Methods and analysisThe study is a multicentre, randomised, superiority, clinical trial. Participants will be 310 individuals with a diagnosis of an ED. They will be randomised to a treatment as usual (individual cognitive behavioural therapy) or a UP condition in a blended format (face-to-face individual UP +online, app-based UP). Primary outcomes will be ED diagnostic criteria and depression and anxiety symptoms. Cost efficiency of the intervention, app usability, as well as opinion and confidence in the treatment will also be evaluated. Assessment points will include baseline and 3 months, 6 months and 12 months after UP treatment.Ethics and disseminationThe study has received approvals by the Ethics Research Committee of Navarra, Castellón, Euskadi, Castilla y León, Extremadura, Lleida and Aragón. The study is currently under an approval process by the Ethics Research Committees of all the remaining collaborating centres. Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.Trial registration numberNCT04304911.