Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial

Abstract

BackgroundEmotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internet-based treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients’ acceptance) of using a self-applied Internet-based program. This paper presents the study protocol.MethodsThe study is a randomized controlled trial. 207 participants will be randomly assigned to: a)Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants’ treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month follow-ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed.DiscussionTo the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED.Trial registrationClinicalTrial.gov: NCT02578758. Registered 15 October 2015.

A brief online transdiagnostic measure: Psychometric properties of the Overall Anxiety Severity and Impairment Scale (OASIS) among Spanish patients with emotional disorders

“…Two subsamples were used for the analysis of sensitivity to change. Subsample 1 consisted of 24 patients who completed an Internet-based treatment for depression [ 52 ], and subsample 2 was made up of 68 patients who underwent a transdiagnostic Internet-based treatment for anxiety and depressive disorders [ 53 , 54 ]. To examine potential floor and ceiling effects for the OASIS scores, the frequency and percentage of minimum (0) and maximum (20) scores was tabulated for subsamples 1 and 2 on the pretest.…”

“…Part of the total sample completed the OASIS before and immediately after receiving an Internet-based treatment. Thus, 24 patients received Smiling is Fun [ 52 ] (hereinafter subsample 1 ), and 68 patients received Emotion Regulation [ 53 , 54 ] (hereinafter subsample 2 ). Smiling is Fun is an 8-module Internet-based treatment for depression that includes components of evidence-based treatments.…”

Dropping out of a transdiagnostic online intervention: A qualitative analysis of client's experiences

“…The other RCT seeks to study the differential efficacy of a transdiagnostic IBT that includes a treatment component to enhance positive affectivity in a community sample. In this protocol, the contents are organized in 16 modules ( Díaz-García et al, 2017 ). These two studies have three important characteristics in common: 1) Both treatments target ED, namely, major depressive disorder, dysthymic disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, and not otherwise specified mood and anxiety disorders; 2) Both treatments are based on the transdiagnostic approach to the treatment of ED ( Barlow et al, 2004 ) for which several studies have shown its the efficacy and effectiveness in improving symptomatology, functionality, quality of life, and emotion regulation skills of patients with emotional disorders in both naturalistic and randomized controlled trials (RCTs) ( Dear et al, 2011 , Farchione et al, 2012 , Johnston et al, 2011 , Titov et al, 2013 ); and 3) Both treatment protocols are web-based, self-administered treatments with minimum contact/support from a therapist that consists in a weekly phone call lasting 5 to 10 min to each participant.…”

Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders

“…Sample 1 included participants with a diagnosis of anxiety and/or depressive disorder that received a transdiagnostic Internet-based protocol for emotional disorders; sample 2 included participants with a diagnosis of adjustment disorder that participated in an Internet-based protocol for the treatment of these disorders; and sample 3 included participants with a diagnosis of depression that received a brief online depression protocol. A full description of the treatments can be found elsewhere [35][36][37]. All the participants were assessed with a structured diagnostic interview.…”