TY - JOUR
T1 - Digital psychosocial intervention for depression among older adults in socioeconomically deprived areas in Brazil (PRODIGITAL-D)
T2 - protocol for an individually randomised controlled trial
AU - Nakamura, Carina Akemi
AU - Scazufca, Marcia
AU - Moretti, Felipe Azevedo
AU - Didone, Thiago Vinicius Nadaleto
AU - de Sá Martins, Mariana Mendes
AU - Pereira, Luara Aragoni
AU - de Souza, Caio Hudson Queiroz
AU - de Oliveira, Gabriel Macias
AU - da Costa, Marcelo Oliveira
AU - Machado, Marcelo
AU - da Silva Bitencourt, Evelyn
AU - Dos Santos, Monica Souza
AU - Murdoch, Jamie
AU - van de Ven, Pepijn
AU - Seward, Nadine
AU - Hollingworth, William
AU - Peters, Tim J.
AU - Araya, Ricardo
N1 - Funding Information:
We would like to acknowledge the staff of the UBSs in Guarulhos participating in the study, Maria de Jesus Assis Ribeiro, Marcelo Bueno da Silva, and other members of the ‘Escola SUS-Guarulhos’ and the Guarulhos Health Secretariat who have supported the conduction of the study; we also would like to thank the TSC and DMC members.
Funding Information:
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). FAPESP supported CAN (2018/19343-9), FAM (2020/02272-1), TVND (2021/04493-8), MMSM (2021/03849-3), CHQS (2020/14504-4), GMO (2021/04230-7), MOC (2020/14768-1), and MSS (2021/10148-1). MS is supported by CNPq-Brazil (307579/2019-0). For the purpose of open access, the authors have applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. The funding bodies did not have any role in the design of the study or data collection, analyses, or interpretation of the data or in writing the manuscript.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - BACKGROUND: Depression in older adults is a challenge for health systems in most low- and middle-income countries (LMICs). Digital strategies for the management of this condition have been emerging worldwide, but the effectiveness of most of them is still unclear, especially among older adults. Thus, we aim to assess the effectiveness and cost-effectiveness of a digital psychosocial intervention to treat depression among older adults living in socioeconomically deprived areas in Guarulhos, Brazil. METHODS: We will conduct a two-arm individually randomised controlled trial with 1:1 allocation ratio. Five hundred older adults aged 60 years or over with depressive symptomatology (9-item Patient Health Questionnaire score, PHQ-9 ≥ 10) and registered with one of the primary care clinics will be recruited to participate in this study. A 6-week digital psychosocial programme, named Viva Vida, will be delivered via WhatsApp to participants allocated to the intervention arm. The Viva Vida will send psychoeducational and behavioural activation audio and visual messages 4 days a week for 6 weeks. The control arm will only receive a single message with general information about depression. The primary outcome will be the proportion of depression recovery (PHQ-9 < 10) assessed at 3 months. The cost-effectiveness of the intervention will be assessed at 5 months. A detailed process evaluation will be used to explore context and important implementation outcomes. DISCUSSION: This programme was based on the PROACTIVE intervention and designed to be delivered without face-to-face contact. If effective, it could be a simple treatment option, appropriate not only when social distancing is required, but it could also be included as a regular public health programme to initiate depression treatment, particularly in LMICs where resources allocated to mental health are scarce. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).
AB - BACKGROUND: Depression in older adults is a challenge for health systems in most low- and middle-income countries (LMICs). Digital strategies for the management of this condition have been emerging worldwide, but the effectiveness of most of them is still unclear, especially among older adults. Thus, we aim to assess the effectiveness and cost-effectiveness of a digital psychosocial intervention to treat depression among older adults living in socioeconomically deprived areas in Guarulhos, Brazil. METHODS: We will conduct a two-arm individually randomised controlled trial with 1:1 allocation ratio. Five hundred older adults aged 60 years or over with depressive symptomatology (9-item Patient Health Questionnaire score, PHQ-9 ≥ 10) and registered with one of the primary care clinics will be recruited to participate in this study. A 6-week digital psychosocial programme, named Viva Vida, will be delivered via WhatsApp to participants allocated to the intervention arm. The Viva Vida will send psychoeducational and behavioural activation audio and visual messages 4 days a week for 6 weeks. The control arm will only receive a single message with general information about depression. The primary outcome will be the proportion of depression recovery (PHQ-9 < 10) assessed at 3 months. The cost-effectiveness of the intervention will be assessed at 5 months. A detailed process evaluation will be used to explore context and important implementation outcomes. DISCUSSION: This programme was based on the PROACTIVE intervention and designed to be delivered without face-to-face contact. If effective, it could be a simple treatment option, appropriate not only when social distancing is required, but it could also be included as a regular public health programme to initiate depression treatment, particularly in LMICs where resources allocated to mental health are scarce. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).
KW - Behavioural activation
KW - Brazil
KW - Depression
KW - Digital intervention
KW - Low- and middle-income countries
KW - Process evaluation
KW - Psychoeducation
KW - Psychosocial intervention
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85137461037&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06623-z
DO - 10.1186/s13063-022-06623-z
M3 - Article
C2 - 36071463
AN - SCOPUS:85137461037
SN - 1745-6215
VL - 23
SP - 761
JO - Trials
JF - Trials
IS - 1
M1 - 761
ER -
