Effect of a low-intensity digital intervention on recovery from depression among older adults in Brazil: a randomised clinical trial

medRxiv (Cold Spring Harbor Laboratory)(2023)

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摘要
Importance: There is an urgent need to provide scalable solutions to treat depression amongst older adults in poorly resourced settings. Objective: To assess the effectiveness of the Viva Vida digital psychosocial intervention for the treatment of depression among older adults. Design: Pragmatic, two-arm, individually randomised controlled trial with a 1:1 allocation ratio. Setting: Twenty-four primary care clinics in Guarulhos, Brazil. Participants: Older adults (60+ years) registered with these clinics were contacted by phone for a screening assessment provided that an active mobile number was available from their primary care records. A two-stage screening for depressive symptomatology with the Patient Health Questionnaire (PHQ) two-items followed by PHQ 9-items was applied. Those who scored ≥ 10 on the PHQ-9 were assessed at baseline and invited to participate. A total of 603 participants were recruited between September 2021 and April 2022, and followed-up to September 2022. Interventions: The Viva Vida psychosocial programme was offered to the intervention arm (n=298). Over six weeks, participants received 48 audio and visual messages based on psychoeducation and behavioural activation sent by WhatsApp. Health professionals were not involved. The control arm received a single message with information about depression (n=305). Both groups received routine primary care. Main outcomes: The primary outcome was recovery from depression (PHQ-9 score<10) at the three-month follow-up. Depression at five months was a secondary outcome. Results: Of 603 participants (mean age, 65.1 years; 451 (74.8%) women), 527 (87.4%) completed the three-month follow-up assessment. At this follow-up, 109 of 257 (42.4%) participants in the intervention arm had recovered from depression, compared with 87 of 270 (32.2%) participants in the control arm (adjusted odds ratio: 1.56; 95% CI: 1.07, 2.27; P =.021). This benefit was not maintained at the five-month follow-up (adjusted odds ratio: 1.02; 95% CI: 0.71, 1.47; P =.892). Conclusions and relevance: These results demonstrate the usefulness in reducing depressive symptoms using a self-help intervention that can be readily integrated into primary care programmes for treating older adults with depression. More research is needed to understand how the intervention can be optimised to maintain benefits in the longer term. Trial Registration: ReBEC registration: RBR-4c94dtn (). Key points Question: Can a low-intensity digital (self-help) psychosocial intervention delivered by automated WhatsApp audio and visual messages over six weeks improve depression recovery among older adults in Brazil? Findings: In this randomised controlled trial involving 603 older adults with depressive symptomatology, the Viva Vida digital intervention substantially improved recovery from depression compared with enhanced usual care at three months (42.4% versus 32.2%; odds ratio: 1.56). However, this difference was not maintained at five months. Meaning: The Viva Vida programme is a simple and easily scalable strategy, that can be integrated as a first step in the treatment of older adults with depression in primary care. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial RBR4c94dtn ### Funding Statement This study was funded by the Sao Paulo Research Foundation (FAPESP process number 2017/500942) and the Joint Global Health Trials initiative, jointly funded by the Medical Research Council, Wellcome Trust, and the UK Department for International Development (process number MR/R006229/1). MS is supported by the CNPq-Brazil (307579/20190), CAN is supported by the Sao Paulo Research Foundation (2018/193430). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics Committee of the Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo HCFMUSP (CAPPesq, ref: 4.097.596, first approved on 10 March 2021) gave ethical approval for this work, and it was authorised by the Guarulhos Health Secretary. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
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digital intervention,depression,clinical trial,recovery,low-intensity
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