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Randomized Controlled Trial
. 2021 Jul 6;18(14):7239.
doi: 10.3390/ijerph18147239.

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

Itxaso González-Ortega  1   2   3   4 , Patricia Vega  1   2   4 , Enrique Echeburúa  1   5 , Susana Alberich  1   2   6 , Jessica Fernández-Sevillano  1   2   4 , Sara Barbeito  1   7 , Vicent Balanzá-Martínez  1   8 , Eduard Vieta  1   9 , Esther Lorente-Rovira  1   10 , Ana Luengo  10 , Ester Cerrillo  11 , José Manuel Crespo  1   11 , Carlos Matute  12   13 , Ana González-Pinto  1   2   4
Affiliations
Randomized Controlled Trial

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

Itxaso González-Ortega et al. Int J Environ Res Public Health. .

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.

Keywords: early intervention; first-episode psychosis; outcome; randomised controlled trial; treatment.

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Conflict of interest statement

Ana González-Pinto has received grants from or served as a consultant, advisor, or CME speaker for the following entities: Almirall, AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, Glaxo-Smith-Kline, Janssen-Cilag, Ferrer, Johnson & Johnson, Lundbeck, Merck, Otsuka, Pfizer, Sanofi-Aventis, Servier, Shering-Plough, Solvay, the Spanish Ministries of Science and Innovation (through CIBERSAM) and of Science (through the Carlos III Institute of Health), the Basque Government, the Stanley Medical Research Institute, and Wyeth. Eduard Vieta has received grants and served as consultant, advisor, or CME speaker for the following entities (unrelated to the present work): AB-Biotics, Abbott, Allergan, Angelini, Dainippon Sumitomo Pharma, Ferrer, Gedeon Richter, Janssen, Lundbeck, Otsuka, Sage, Sanofi-Aventis, and Takeda. Jose Manuel Crespo has received grants and served as a consultant or speaker for the following entities (unrelated to the present work): Ferrer, Janssen, Lundbeck-Otsuka and Sanofi Aventis, and the Spanish Ministries of Science and Innovation (through CIBERSAM) and of Science (through the Carlos III Institute of Health). The other authors have no other conflicts of interest to declare.

Figures

Figure 1
Figure 1
The CONSORT flow diagram.
See this image and copyright information in PMC

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