Implementing the protocol of a pilot randomized controlled trial for the recovery-oriented intervention to people with psychoses in two Latin American cities.

Franco Mascayano,Eric Tapia,Sarah Conover,Catarina Magalhães Dahl,Graciela Rojas,Eliecer Valencia,Lawrence H Yang,Kim Fader,Giovanni Marcos Lovisi,Joy Noel Baumgartner,Sara Schilling,Sandro Galea,Keli Rodrigues Sarução,Prakash Gorroochurn,Charissa Pratt,Howard Andrews ,Maria Restrepo-Toro ,Peter Šťastný ,Rubén Alvarado ,Flávia Mitkiewicz De Souza ,María Soledad Burrone ,María Tavares Cavalcanti ,Robert A Rosenheck ,Jacqueline Fernandes De Cintra ,María José Jorquera ,Ezra Süsser

doi:10.1590/0102-311x00108018

Abstract

Several Latin American countries have made remarkable strides towards offering community mental health care for people with psychoses. Nonetheless, mental health clinics generally have a very limited outreach in the community, tending to have weaker links to primary health care; rarely engaging patients in providing care; and usually not providing recovery-oriented services. This paper describes a pilot randomized controlled trial (RCT) of Critical Time Intervention-Task Shifting (CTI-TS) aimed at addressing such limitations. The pilot RCT was conducted in Santiago (Chile) and Rio de Janeiro (Brazil). We included 110 people with psychosis in the study, who were recruited at the time of entry into community mental health clinics. Trial participants were randomly divided into CTI-TS intervention and usual care. Those allocated to the intervention group received usual care and, in addition, CTI-TS services over a 9-month period. Primary outcomes include quality of life (WHO Quality of Life Scale - Brief Version) and unmet needs (Camberwell Assessment of Needs) at the 18-month follow-up. Primary outcomes at 18 months will be analyzed by Generalized Estimating Equations (GEE), with observations clustered within sites. We will use three-level multilevel models to examine time trends on the primary outcomes. Similar procedures will be used for analyzing secondary outcomes. Our hope is that this trial provides a foundation for planning a large-scale multi-site RCT to establish the efficacy of recovery-oriented interventions such as CTI-TS in Latin America.

Highlights

IntroductionIn 1990, the Caracas Declaration marked the beginning of a new era in mental health care in Latin America 1
Community care for people with psychoses in Latin AmericaIn 1990, the Caracas Declaration marked the beginning of a new era in mental health care in Latin America 1
We describe here a pilot randomized clinical trial (RCT) (Registration number: NCT01995864) of a recovery-oriented, task-shifting intervention for individuals with psychosis, which was conducted at Community Mental Health Centers (CMHCs) in two Latin American cities: Rio de Janeiro (Brazil) and Santiago (Chile)

Summary

Introduction

In 1990, the Caracas Declaration marked the beginning of a new era in mental health care in Latin America 1. This Declaration put forth a multifaceted progressive agenda, within which one of the key goals was to shift the major locus of care for people with psychoses and other severe mental disorders from psychiatric hospitals to community settings. Several Latin American countries have developed broad societal legislation and made remarkable strides towards offering care in the community. This progress, has been uneven across countries [2,3]. By describing what we planned to do and what was implemented, we hope to shed some light on the difficulties such endeavors often face

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