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Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial.
Trials ( IF 2.5 ) Pub Date : 2020-01-10 , DOI: 10.1186/s13063-019-3890-6
Stephanie S Leone 1 , Suzanne Lokman 2 , Brigitte Boon 3, 4 , Agnes van der Poel 3 , Filip Smit 1, 5 , Moniek Zijlstra-Vlasveld 6 , Odile Smeets 3
Affiliation  

BACKGROUND Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. METHODS/DESIGN The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. DISCUSSION This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. TRIAL REGISTRATION Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.

中文翻译:

对初级保健中的抑郁症患者实施针对患者的针对投诉的小型干预措施,以提高社会经济地位较低的患者的参与度:一项整群随机对照试验的设计。

背景技术抑郁症是主要的公共卫生问题。事实证明,用于预防和减少抑郁症投诉的电子医疗干预措施是有效的,并且有可能使(精神)医疗保健更容易获得和更有效。但是,这些干预措施的影响范围需要改善,尤其是在社会经济地位较低的人群中。刺激和支持在初级保健中实施电子卫生,并从全科护​​士(GP护士)提供指导可能是实现此目标的重要策略。方法/设计针对压力,睡眠和忧虑投诉的在线“投诉式小型干预”(CDMI),以自我指导的形式被认为具有(成本效益),将在初级保健机构中使用混合护理形式(即 将电子保健与面对面的课程结合起来),而GP护士提供的指导则很少。主要目的是评估与集群随机对照试验中的常规实施策略相比,SES敏感型实施策略是否提高了低SES患者在混合在线CDMI中的参与率(即达到率)。随机化将在GP护士级别进行,该研究将包括228名患者。主要结果是低社会经济地位目标群体的参与率(至少完成一次面对面会议和两次在线练习)。假设与普通组相比,在SES敏感组中该百分比会更高。次要目标是评估实施过程,监控和评估心理不适(抑郁,睡眠,压力,忧虑和焦虑)和幸福感。患者评估将在基线,基线后3个月和12个月进行。讨论本研究应为我们提供知识,以一种简短且针对特定投诉的混合方法来解决初级保健中的抑郁投诉,从而使我们能够将低SES人群覆盖。它还应该进一步了解在初级保健中实施预防抑郁的成功策略的知识。试用注册荷兰试用注册,ID:NL6595。2017年11月12日注册。它还应该进一步了解在初级保健中实施预防抑郁的成功策略的知识。试用注册荷兰试用注册,ID:NL6595。2017年11月12日注册。它还应该进一步了解在初级保健中实施预防抑郁的成功策略的知识。试用注册荷兰试用注册,ID:NL6595。2017年11月12日注册。
更新日期:2020-01-11
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