A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol

Trials

Antônio Seabra¹  Renato M. Franzin¹  Maiara Garcia Henrique²  Daniele Ferreira Martins²  Ehidee Gomez La Rotta²  Carina Akemi Nakamura²  Pepijn Van de Ven³  Marcia Scazufca⁴  Ricardo Araya⁵  Tim J. Peters⁶  William Hollingworth⁶ 

[1] Departamento de Engenharia Eletrica, Escola Politecnica, Universidade de Sao Paulo;Faculdade de Medicina FMUSP, Universidade de Sao Paulo;Faculty of Science and Engeneering, University of Limerick;Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo;Institute of Psychiatry Psychology and Neurosciences, King’s College London;University of Bristol Medical School;

关键词: Depression;    Collaborative care;    Elderly;    Randomised controlled trial;    Primary healthcare;    Protocol;   

DOI  :  10.1186/s13063-020-04826-w

来源: DOAJ

【 摘 要 】

Abstract Background The elderly population has been growing in most low- and middle-income countries (LMIC), and depression is a common condition among these populations. The lack of integration between mental health and primary healthcare services and the shortage of mental health specialists in the public health system contribute to underdiagnosis and undertreatment of depression. One of the strategies to reduce this gap is task shifting and collaborative care treatments. This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil. Methods Two-arm, cluster randomised controlled trial with Basic Health Units as the clusters and a 1:1 allocation ratio. Twenty Basic Health Units have been randomly selected and randomised to control or intervention arms. We aim to recruit 1440 adults (72 per cluster) aged 60 years or over identified with depression (9-item Patient Health Questionnaire (PHQ-9) score ≥ 10). The control arm participants will receive an enhanced usual care, while the intervention arm participants will receive an enhanced usual care and a 17-week psychosocial intervention programme delivered at home by community health workers with the help of an application installed on tablet computers. The primary outcome is the proportion with depression recovery (PHQ-9 < 10) at 8 months’ follow-up. We will also assess the maintenance of any earlier clinical gains and the cost-effectiveness of the intervention at 12 months. Discussion This is the first randomised trial to investigate a collaborative care intervention to treat depression among poor elderly in LMIC/Latin America. This is a major public health problem worldwide, but in these countries, there are no locally tested, evidence-based interventions available to date. Trial registration International Standard Randomised Controlled Trial Number ISRCTN57805470 . Registered on 25 April 2019

【 授权许可】

Unknown