Protocol to evaluate the effectiveness of the implementation of transdiagnostic cognitive behavioural therapy for emotional disorders in primary care and its mechanisms of change: a randomized step-wedge clinical trial (PsicAP-CV)

Abstract

Introduction Emotional disorders (ED) are highly prevalent worldwide. The PsicAP trial, conducted in Spain, demonstrated the benefits of adding transdiagnostic cognitive behavioural therapy (TD-CBT) to treatment as usual (TAU) for the attention of these disorders in primary care (PC). Here we describe the design of a stepped wedge randomized controlled trial (RCT), inspired by the PsicAP project. This RCT has two main aims: 1) to test the implementation of the PsicAP protocol in a real clinical setting, further evaluating possible mechanisms of change underlying the efficacy of TD-CBT (emotional regulation, alliance, and therapist experience and training), and 2) to assess the impact of psychotropic medication use on neuropsychological function and treatment outcomes. Methods A single-blind multicentre RCT with a stepped wedge design will be conducted. Participants (N=320) will be randomly assigned to an experimental group (EG1) or to a waiting list group (WG). The EG1 will receive immediate treatment and the WG will remain on the waiting list for 3 months. After this time, the WG will become a second experimental group (EG2) that will receive the same treatment as EG1 (PsicAP protocol). Patients will be assessed at post-treatment, at 3 and 9 months. Before starting treatment, a random subsample of patients (n=90) will undergo a neuropsychological assessment. These patients will be assigned to three groups based on their use of psychotropic medication at the time of randomization: no psychotropic medication, short-term use (< 3 months) and long-term use (≥ 3 months). All 90 participants will undergo the same neuropsychological assessment at one year. The RCT is expected to run from 01/05/23 to 01/10/25. Discussion The results of this trial are expected to provide further support for the efficacy of the PsicAP TD-CBT protocol, as well as insight into the mechanisms of change that lead to the positive therapeutic outcomes of this protocol. In addition, this study will help determine the effects of short- and long-term psychotropic use on neuropsychological function and therapeutic outcomes. In short, it is hoped that this RCT will help to better understand how to implement evidence-based psychological treatment in the PC setting. Trial registration EURADICT 2013-001955-11/ ISRCTN58437086.