Effectiveness of a multidimensional collaborative approach versus usual care in the treatment of adult depression in primary care in Chile: study protocol for a single blinded cluster randomized controlled trial.

Q2 Pharmacology, Toxicology and Pharmaceutics
F1000Research Pub Date : 2024-10-11 eCollection Date: 2022-01-01 DOI:10.12688/f1000research.75764.2
Veronica Vitriol, Alfredo Cancino, Andres Sciolla, Sergio Guiñez, Jorge Calvo, Marcela Ormazabal, Johanna Kreither, Soledad Ballesteros, Maria DE LA Luz Aylwin
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引用次数: 0

Abstract

Background: Major depression (MD) is a prevalent and disabling condition in Chile, with most cases being treated at the primary care level. In Chilean primary care, the authors have identified key factors associated with more complex presentations of MD and a poorer prognosis, such as a history of childhood trauma, suicidality, and comorbidities. These findings underscore the need for a multidimensional, trauma-informed, and interprofessional approach to the treatment of depression.

Methods: This protocol is a two-arm, single-blinded, cluster RCT to compare the effectiveness of a collaborative multidimensional approach for depression (CMAD) versus usual care to treat MD in primary care clinics in Chile. In total, 394 depressed adults from 18 to 65 years of age in twelve clinics located in Chile's Maule Region will be consented to participate in the study. Patients and care teams from each clinic will be randomized to the intervention or to the control arm.Interprofessional teams in the intervention arm will attend 27 hours of didactic and active learning sessions focused on clinical competences to effectively engage, treat and follow up patients with the factors associated to the complex presentation of MD. Team in the control arm will receive 27 didactic sessions on current clinical guidelines for MD.Patients of both arms will be blindly assessed at baseline, three months, and six months. The primary outcome will be the reduction in depressive symptoms, with secondary outcomes including improvements in anxiety symptoms, interpersonal and social functioning, and treatment adherence.

Discussion: This protocol proposes the evaluation of an intervention designed to improve depression symptoms by enhancing the clinical competencies of primary care teams. These competencies are structured around collaborative care and trauma-informed practices.

Trial registration: NCT05016388, registered on 16 August 2021 at ClinicalTrials.gov.

多维协作疗法与常规护理在智利成人抑郁症初级保健治疗中的效果对比:单盲群组随机对照试验的研究方案。
背景介绍在智利,重度抑郁症(MD)是一种常见的致残性疾病,大多数病例都在初级医疗机构接受治疗。在智利的初级保健中,作者发现了与重度抑郁症的复杂表现和较差预后相关的关键因素,如童年创伤史、自杀倾向和合并症。这些发现强调了采用多维、创伤知情和跨专业方法治疗抑郁症的必要性:本方案是一项双臂、单盲、分组 RCT 研究,旨在比较多维抑郁协作疗法(CMAD)与常规护理在智利初级保健诊所治疗抑郁症的效果。智利毛莱大区的 12 家诊所共有 394 名 18 岁至 65 岁的抑郁症成人同意参加这项研究。干预组的跨专业团队将参加 27 个小时的说教和主动学习课程,重点学习临床能力,以便有效地接触、治疗和随访与抑郁症复杂表现相关的患者。两组患者将在基线、三个月和六个月时接受盲法评估。主要结果是抑郁症状的减轻,次要结果包括焦虑症状、人际交往和社会功能以及治疗依从性的改善:本方案建议对一项干预措施进行评估,旨在通过提高初级保健团队的临床能力来改善抑郁症状。这些能力是围绕协作护理和创伤知情实践构建的:NCT05016388,2021年8月16日在ClinicalTrials.gov注册。
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来源期刊
F1000Research
F1000Research Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
5.00
自引率
0.00%
发文量
1646
审稿时长
1 weeks
期刊介绍: F1000Research publishes articles and other research outputs reporting basic scientific, scholarly, translational and clinical research across the physical and life sciences, engineering, medicine, social sciences and humanities. F1000Research is a scholarly publication platform set up for the scientific, scholarly and medical research community; each article has at least one author who is a qualified researcher, scholar or clinician actively working in their speciality and who has made a key contribution to the article. Articles must be original (not duplications). All research is suitable irrespective of the perceived level of interest or novelty; we welcome confirmatory and negative results, as well as null studies. F1000Research publishes different type of research, including clinical trials, systematic reviews, software tools, method articles, and many others. Reviews and Opinion articles providing a balanced and comprehensive overview of the latest discoveries in a particular field, or presenting a personal perspective on recent developments, are also welcome. See the full list of article types we accept for more information.
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