Departamento de Psiquiatria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Trials. 2022 Sep 7;23(1):761. doi: 10.1186/s13063-022-06623-z.
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.
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.
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.
Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).
在大多数中低收入国家（LMICs），老年人的抑郁症是对卫生系统的挑战。数字策略已在全球范围内出现，用于管理这种疾病，但大多数数字策略的有效性仍不清楚，尤其是在老年人中。因此，我们旨在评估一种数字心理社会干预措施在巴西瓜鲁柳斯（Guarulhos）社会经济贫困地区治疗老年人抑郁症的效果和成本效益。
我们将开展一项 1:1 随机分组的双臂对照试验。将招募 500 名年龄在 60 岁及以上、有抑郁症状（9 项患者健康问卷评分，PHQ-9≥10）且在其中一个初级保健诊所登记的老年人参与本研究。分配到干预组的参与者将接受为期 6 周的数字心理社会方案 Viva Vida。Viva Vida 将通过 WhatsApp 每周 4 天发送心理教育和行为激活的音频和视频信息，共 6 周。对照组将只收到一条关于抑郁症的一般信息。主要结局是 3 个月时评估的抑郁缓解率（PHQ-9<10）。干预的成本效益将在 5 个月时进行评估。将进行详细的过程评估，以探索背景和重要的实施结果。
该方案基于 PROACTIVE 干预措施，旨在无需面对面接触即可实施。如果有效，它可能是一种简单的治疗选择，不仅在需要保持社交距离时适用，而且还可以作为常规公共卫生计划纳入其中，以启动抑郁症治疗，特别是在资源分配给精神健康的资源稀缺的 LMICs。
巴西临床试验注册处（ReBEC），RBR-4c94dtn。于 2021 年 10 月 22 日注册（于 2021 年 8 月 3 日提交）。
