Administrative information
Title {1} | “Digital psychosocial intervention for depression among older adults in socioeconomically deprived areas in Brazil (PRODIGITAL-D): protocol for an individually randomised controlled trial” |
Trial registration {2a and 2b}. | Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. |
Protocol version {4} | Version 5.0, 16 March 2022. |
Funding {4} | This study was funded by São Paulo Research Foundation (FAPESP, process number 2017/50094-2) and the Joint Global Health Trials initiative jointly funded by Medical Research Council, Wellcome Trust, and the UK Department for International Development (MRC, process number MR/R006229/1). |
Author details {5a} | (1) Departamento de Psiquiatria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil (2) Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (3) Debasé Audiovisual, Sao Paulo, Brazil (4) Faculdade de Arquitetura e Urbanismo FAU, Universidade de Sao Paulo, Sao Paulo, Brazil (5) Department of Population Health Sciences, King’s College London, London, UK (6) Health Research Institute, University of Limerick, Limerick, Ireland (7) Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK (8) Health Economics Bristol, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK (9) Population Health Sciences, Bristol Medical School, and Bristol Dental School, University of Bristol, Bristol, UK |
Name and contact information for the trial sponsor {5b} | Sponsors: Universidade de Sao Paulo (USP), Brazil King’s College London (KCL), United Kingdom Principal Investigators contact: Dr Marcia Scazufca, Universidade de Sao Paulo, Brazil scazufca@usp.br Professor Ricardo Araya, King’s College London, United Kingdom ricardo.araya@kcl.ac.uk |
Role of sponsor {5c} | The sponsors and funders have no roles in the design and conduction of the study, data analysis and interpretation, or in the writing or submission of the manuscript for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
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Individuals aged 60 or over
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Individuals registered with any of the participating UBSs
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Individuals able to receive and listen to WhatsApp messages
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Individuals screening positive for depressive symptomatology on the Patient Health Questionnaire (PHQ; scores of PHQ-2 ≥ 1 and PHQ-9 ≥ 10) [11]
Exclusion criteria
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Individuals with communication issues (non-Portuguese speaking, cognitively impaired or other problem hindering communication to engage in trial assessments or intervention, such as vision or hearing problems)
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Individuals unable to engage in the study for the total period of five months (terminal illness or partner with terminal illness, other)
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Individuals presenting acute suicidal risk (i.e. reported suicidal attempt in the two weeks prior to the screening assessment, as assessed by the 9th item of the PHQ-9 and the Immediate Suicide Risk Protocol)
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Individuals living in the same household as another participant in the study
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Individuals who participated in the PROACTIVE trial