scholarly journals 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

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e054286
Author(s):  
J Osma ◽  
Laura Martínez-García ◽  
Óscar Peris-Baquero ◽  
María Vicenta Navarro-Haro ◽  
Alberto González-Pérez ◽  
...  

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.

2020 ◽  
Vol 24 (3) ◽  
pp. 197 ◽  
Author(s):  
Bonifacio Sandín ◽  
Rosa M. Valiente ◽  
Julia García-Escalera ◽  
David Pineda ◽  
Victoria Espinosa ◽  
...  

Abstract: Internet-delivered unified protocol for transdiagnostic treatment of emotional disorders in adolescents (iUP-A): Web application and study protocol for a randomized controlled trial. A characteristic of transdiagnostic treatment is that it targets simultaneously the core symptoms and underlying vulnerabilities of several disorders. The UP-A is a new empirically supported cognitive-behavioral therapy (CBT) protocol developed by Ehrenreich-May’s group for the transdiagnostic treatment approach of emotional disorders (i.e., depression, anxiety and related disorders) in adolescents (Ehrenreich-May et al., 2018), to be applied in a face-to-face format. Internet-delivered psychological treatments represent an emerging model to improve access to evidence-based CBT. A first aim of this study is to describe the development of a web application named Aprende a Manejar Tus Emociones (AMTE; Learn to Manage Your Emotions), designed to implement the UP-A in order to be delivered via internet (iUP-A). A second objective is to test the efficacy of the iUP-A for the treatment of depression and anxiety disorders compared to waiting list, in a randomized controlled trial. We investigated changes in a broad range of primary, secondary and transdiagnostic outcome measures.Keywords: Transdiagnostic; UP-A; iUP-A; internet-delivered CBT; AMTE; anxiety; depression.Resumen: Una característica del tratamiento transdiagnóstico consiste en que aborda simultáneamente los síntomas principales y las vulnerabilidades que subyacen a varios trastornos. El UP-A es un nuevo protocolo de terapia cognitivo-conductual (TCC) basada en la evidencia desarrollado por el grupo de Ehrenreich-May para un tratamiento transdiagnóstico de los trastornos emocionales (i.e., depresión, ansiedad y trastornos relacionados) en adolescentes (Ehrenreich-May et al., 2018), para ser aplicado en un formato cara-a-cara. Los tratamientos psicológicos dispensados a través de internet representan un modelo emergente para mejorar el acceso a la TCC basada en la evidencia. Un primer objetivo del presente estudio consiste en describir el desarrollo de una aplicación web denominada Aprende a Manejar Tus Emociones (AMTE), diseñada para implementar el UP-A con objeto de ser dispensado a través de internet (iUP-A). Un segundo objetivo es probar la eficacia del iUP-A para el tratamiento de la depresión y los trastornos de ansiedad en comparación con una lista de espera, en un ensayo controlado aleatorizado. Se investigan los cambios en un amplio rango de medidas de resultado primarias, secundarias y transdiagnósticas.Palabras clave: Transdiagnóstico; UP-A; iUP-A; TCC por internet; AMTE; ansiedad; depresión. 


2017 ◽  
Vol 41 (4) ◽  
pp. 529-557 ◽  
Author(s):  
Kate H. Bentley ◽  
Shannon Sauer-Zavala ◽  
Clair F. Cassiello-Robbins ◽  
Laren R. Conklin ◽  
Stephanie Vento ◽  
...  

We provide a theoretical rationale for applying a transdiagnostic, shared mechanism treatment (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders [UP]) to suicidal thoughts and behaviors. We also present results from a proof of concept study examining the feasibility and acceptability of adding a modified UP to treatment as usual (TAU) in an inpatient setting for individuals reporting a recent suicide attempt or active suicidal ideation. Participants ( N = 12) were randomly assigned to receive UP + TAU or TAU alone. Findings indicate good feasibility and acceptability of the adjunctive intervention. Among participants who were responsive to contact attempts postdischarge ( n = 6), there were no observable differences in suicidal thoughts or behaviors during a 6-month follow-up. This application represents a promising initial extension of a cognitive-behavioral, emotion-focused treatment to suicidal individuals within an inpatient setting. Future studies adequately powered to speak to efficacy of the modified UP intervention are warranted.


2012 ◽  
Vol 43 (3) ◽  
pp. 666-678 ◽  
Author(s):  
Todd J. Farchione ◽  
Christopher P. Fairholme ◽  
Kristen K. Ellard ◽  
Christina L. Boisseau ◽  
Johanna Thompson-Hollands ◽  
...  

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Nabi Nazari ◽  
Akram Aligholipour ◽  
Masoud Sadeghi

Abstract Background Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated. Objective This study aimed to examine the efficacy of a group format of the Unified Protocol (UP) for the Transdiagnostic treatment of depression and anxiety disorders in females with MS. Methods In the present study, Sixty-four adult females diagnosed with MS were randomized to either the UP (n = 32) or treatment-as-usual conditions. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity. Results Repeated measure analysis of variance (ANOVA) revealed that the UP significantly improved depression scores [Cohen’s d = − 2.11, 95% CI (− 2.72, − 1.50)], anxiety scores [Cohen’s d = − 3.34, 95% CI (− 4.01, − 2.58)], positive and negative affect scale (PANAS)-positive affect scores [Cohen’s d = 1.46, 95% CI (1.46, 2.01)], PANAS-negative affect scores [Coen’s d = − 2.21, 95% CI (− 2.84, − 1.60)], difficulties emotion regulation scale scores [Cohen’s d = 1.40, 95% CI (− 0.87, − 0.03)], and Worry scale scores [Cohen’s d = − 0.45, 95% CI (− 0.95, − 0.04)] at the end of treatment relative to compared to the control condition. Also, treatment gains were maintained at the three-month follow-up (p < 0.001). Conclusion The findings provide the support that the UP could be an additional efficient psychological treatment for females with MS. ISRCTN Number: ISRCTN95459505.


2022 ◽  
pp. 1-12
Author(s):  
Masaya Ito ◽  
Masaru Horikoshi ◽  
Noriko Kato ◽  
Yuki Oe ◽  
Hiroko Fujisato ◽  
...  

Abstract Background The efficacy of the unified protocol of the transdiagnostic treatment for emotional disorders (UP) has been poorly studied in patients with depressive disorders. This study aimed to examine the efficacy of UP for improving depressive symptoms in patients with depressive and/or anxiety-related disorders. Methods This assessor-blinded, randomized, 20-week, parallel-group, superiority study compared the efficacy of the UP with treatment-as-usual (UP-TAU) v. wait-list with treatment-as-usual (WL-TAU). Patients diagnosed with depressive and/or anxiety disorders and with depressive symptoms participated. The primary outcome was depressive symptoms assessed by GRID-Hamilton depression rating scale (GRID-HAMD) at 21 weeks. The secondary outcomes included assessor-rated anxiety symptoms, severity and improvement of clinical global impression, responder and remission status, and loss of principal diagnosis. Results In total, 104 patients participated and were subjected to intention-to-treat analysis [mean age = 37.4, s.d. = 11.5, 63 female (61%), 54 (51.9%) with a principal diagnosis of depressive disorders]. The mean GRID-HAMD scores in the UP-TAU and WL-TAU groups were 16.15 (s.d. = 4.90) and 17.06 (s.d. = 6.46) at baseline and 12.14 (s.d. = 5.47) and 17.34 (s.d. = 5.78) at 21 weeks, with a significant adjusted mean change difference of −3.99 (95% CI −6.10 to −1.87). Patients in the UP-TAU group showed significant superiority in anxiety and clinical global impressions. The improvement in the UP-TAU group was maintained in all outcomes at 43 weeks. No serious adverse events were observed in the UP-TAU group. Conclusions The UP is an effective approach for patients with depressive and/or anxiety disorders.


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