Cruz-Riquelme Tatiana, Zevallos-Morales Alejandro, Carrión Ivonne, Otero-Oyague Diego, Patiño Vanessa, Lastra Dafne, Valle Rubén, Parodi José F, Pollard Suzanne L, Steinman Lesley, Gallo Joseph J, Flores-Flores Oscar
Facultad de Medicina Humana, Centro de Investigación del Envejecimiento (CIEN), Universidad de San Martin de Porres, Lima, Peru.
Asociación Benéfica PRISMA, Lima, Peru.
Pilot Feasibility Stud. 2024 Aug 22;10(1):112. doi: 10.1186/s40814-024-01540-1.
Non-pharmacological interventions have proven effective at alleviating depression and anxiety symptoms in older adults. Methodological refinement and testing of these interventions in new contexts are needed on a small scale before their effectiveness and implementation can be evaluated. The purpose of this pilot study is to assess the feasibility of a future large-scale trial comparing an adapted mental health multi-component evidence-based intervention (VIDACTIVA) versus standard care for older adults experiencing depression symptoms in urban, resource-limited settings in Lima, Peru. Furthermore, this study will explore the acceptability, feasibility, and fidelity of implementing the intervention.
We will conduct an open-label, mixed methods pilot feasibility study with two parallel groups. A total of 64 older adults, stratified by sex, will be randomized at a 1:1 ratio to either the "intervention" or "control." Participants will be followed for 22 weeks after enrollment. Those in the intervention group will receive eight VIDACTIVA sessions administered by community health workers (CHWs) over 14 weeks, with an additional eight weeks of follow-up. Participants in the control group will receive two psychoeducation sessions from a study fieldworker and will be directed to health care centers. Standard care does not involve CHWs. We will evaluate screening rates, recruitment strategies, retention rates, the acceptability of randomization, and assessments. Additionally, we will assess preliminary implementation outcomes-acceptability, feasibility, and fidelity-from the perspectives of CHWs (interventionists), older adults (main participants), older adults' relatives, and healthcare professionals.
If the findings from this feasibility trial are favorable, a fully powered randomized controlled trial will be conducted to evaluate `both the effectiveness and implementation of the intervention. This research will make a substantial contribution to the field of mental health in older adults, particularly by emphasizing a meticulous examination and documentation of the implementation process. By doing so, this study will offer valuable methodologies and metrics for adapting and assessing mental health interventions tailored to the unique needs of older adults in resource-constrained contexts and diverse cultural settings.
The current trial registration number is NCT06065020, which was registered on 26th September 2023.
非药物干预已被证明可有效缓解老年人的抑郁和焦虑症状。在评估这些干预措施的有效性和实施情况之前，需要在小规模新环境中对其进行方法改进和测试。本试点研究的目的是评估未来大规模试验的可行性，该试验将比较一种经过调整的基于证据的心理健康多成分干预措施（VIDACTIVA）与针对秘鲁利马城市资源有限环境中出现抑郁症状的老年人的标准护理。此外，本研究将探讨实施该干预措施的可接受性、可行性和保真度。
我们将进行一项开放标签、混合方法的试点可行性研究，分为两个平行组。总共64名按性别分层的老年人将以1:1的比例随机分为“干预组”或“对照组”。参与者在入组后将接受22周的随访。干预组的参与者将在14周内接受由社区卫生工作者（CHW）进行的八次VIDACTIVA课程，并额外随访八周。对照组的参与者将从研究现场工作人员那里接受两次心理教育课程，并被引导至医疗保健中心。标准护理不涉及社区卫生工作者。我们将评估筛查率、招募策略、保留率、随机化的可接受性以及评估情况。此外，我们将从社区卫生工作者（干预者）、老年人（主要参与者）、老年人亲属和医疗保健专业人员的角度评估初步实施结果——可接受性、可行性和保真度。
如果这项可行性试验的结果是有利的，将进行一项充分有力的随机对照试验，以评估该干预措施的有效性和实施情况。这项研究将对老年人心理健康领域做出重大贡献，特别是通过强调对实施过程进行细致的检查和记录。通过这样做，本研究将为适应和评估针对资源受限环境和不同文化背景下老年人独特需求的心理健康干预措施提供有价值的方法和指标。
当前试验注册号为NCT06065020，于2023年9月26日注册。
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