背景: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之前,需要在新的背景下对这些干预措施进行小规模的方法改进和测试。这项初步研究的目的是评估未来大规模试验的可行性,该试验将适应的心理健康多组分循证干预(VIDACTIVA)与标准护理进行比较,以治疗城市中出现抑郁症状的老年人。利马的资源有限的设置,秘鲁。此外,这项研究将探讨可接受性,可行性,和实施干预的保真度。
方法:我们将进行开放标签,混合方法试点可行性研究与两个平行组。共有64名老年人,按性别分层,将以1:1的比例随机分配给“干预”或“对照”。“参与者将在注册后接受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)管理的八次VIDACTIVA会议,再进行8周的随访。对照组的参与者将接受来自研究现场工作者的两次心理教育课程,并将被引导到医疗保健中心。标准护理不涉及CHW。我们将评估筛查率,招聘策略,保留率,随机化的可接受性,和评估。此外,我们将评估初步实施结果-可接受性,可行性,和忠诚-从CHW(干预主义者)的角度来看,老年人(主要参与者),老年人亲属,和医疗保健专业人员。
结论:如果这项可行性试验的结果是有利的,将进行一项完全有效的随机对照试验,以评估干预措施的有效性和实施情况。这项研究将为老年人的心理健康领域做出重大贡献,特别是强调对实施过程进行细致的检查和记录。通过这样做,这项研究将提供有价值的方法和指标,以适应和评估在资源有限的环境和不同的文化背景下适合老年人独特需求的心理健康干预措施.
背景:当前的试用注册号为NCT06065020,于2023年9月26日注册。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: The current trial registration number is NCT06065020, which was registered on 26th September 2023.