A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis.

Itxaso González-Ortega,Ana Luengo,Jessica Fernández-Sevillano,Esther Lorente-Rovira,Enrique Echeburúa,Vicent Balanzá-Martínez,Eduard Vieta,José Manuel Crespo,Sara Barbeito,Patricia Vega,Ana González-Pinto,Carlos Matute,Ester Cerrillo,Susana Alberich

doi:10.3390/ijerph18147239

Abstract

Introduction: There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP). However, further randomised treatment clinical trials are needed. Objectives: The aim of this study was to compare the efficacy of a combined clinical treatment involving Cognitive Behavioural Therapy (CBT) as an adjunctive to treatment-as-usual (TAU) (CBT+TAU) versus TAU alone for FEP. Patients and methods: In this multicentre, single-blind, randomised controlled trial, 177 participants were randomly allocated to either CBT+TAU or TAU. The primary outcome was post-treatment patient functioning. Results: The CBT+TAU group showed a greater improvement in functioning, which was measured using the Global Assessment Functioning (GAF) and Functioning Assessment Short Test (FAST), compared to the TAU group post-treatment. The CBT+TAU participants exhibited a greater decline in depressive, negative, and general psychotic symptoms; a better awareness of the disease and treatment adherence; and a greater increase in brain-derived neurotrophic factor levels than TAU participants. Conclusions: Early intervention based on a combined clinical treatment involving CBT as an adjunctive to standard treatment may improve clinical and functional outcomes in FEP.

Highlights

There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP)
When significant variables in the simple linear regression were included in the multivariate model, the results indicated that improvements in the Clinical Global Impression Scale (CGI)-I (B = −0.693; 95% CI: −0.966 to −0.420; p ≤ 0.001), PANNS-N (B = −0.647; 95% CI: −0.985 to −0.309; p ≤ 0.001), and State-Trait Anxiety Inventory (STAI)-S (B = −0.232; 95% CI: −0.455 to −0.010)
This randomised controlled trial aimed to compare the efficacy of a Cognitive Behavioural Therapy (CBT)+TAU treatment of FEP versus TAU alone, comparing the results at baseline with post-treatment outcomes

Summary

Introduction

There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP). Further randomised treatment clinical trials are needed. Patients and methods: In this multicentre, singleblind, randomised controlled trial, 177 participants were randomly allocated to either CBT+TAU or TAU. The primary outcome was post-treatment patient functioning. First-episode psychosis (FEP) is characterised by relapses, especially if not adequately treated. This may have a negative impact on clinical and functional outcomes in the long term [1]. Factors that have been associated with poorer outcomes include a poor premorbid adjustment, comorbid substance use disorders, greater severity of negative symptoms, history of suicide attempts and suicidal ideation, longer duration of untreated psychosis (DUP), and lack of treatment adherence [2]. BDNF has been suggested to be a useful neurobiological biomarker of early-onset schizophrenia [4,5,6,7,8,9,10].

Objectives

Results

Conclusion