Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

Alberto González-Robles,Francisco Traver,Rosa Baños,Azucena García-Palacios,José Enrique Romeu,Gonzalo Haro,Cristina Botella,Guillem Lera,Vicente Palop,Antonio Riera,Ginés Llorca

doi:10.1186/s13063-015-1024-3

Abstract

BackgroundEmotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied.Methods/DesignThe study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed.DiscussionAlthough the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed.Trial registrationClinicalTrials.gov NCT02345668. Registered 27 July 2015.

Highlights

IntroductionEmotional disorders (depression and anxiety disorders) are highly prevalent mental health problems
Emotional disorders are highly prevalent mental health problems
Discussion: the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low

Summary

Introduction

Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. The medical care costs and production losses associated with these mental health problems in Europe are huge [2] These data strongly suggest that efficacious and efficient treatments are needed to address this important health problem [5,6,7,8]. Despite these alarming data, evidence exists indicating that most people with depression and anxiety disorders (less than 50 %) do not receive treatment. To reduce the burden of mental illness, some authors have emphasized the need for an approach that goes beyond the dominant face-to-face treatment approach in order to provide help to people in need of evidence-based treatments, and this approach includes the use of the media, self-help interventions, the use of special settings and information and communication technologies (ICT) [10]

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