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马拉维成年人重度抑郁症综合慢性病管理的效果、成本效益和正外部性(IC3D):一项阶梯式、整群随机、对照试验。

Effectiveness, cost-effectiveness, and positive externalities of integrated chronic care for adults with major depressive disorder in Malawi (IC3D): a stepped-wedge, cluster-randomised, controlled trial.

机构信息

Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; RAND, Santa Monica, CA, USA.

Partners In Health, Neno, Malawi.

出版信息

Lancet. 2024 Nov 9;404(10465):1823-1834. doi: 10.1016/S0140-6736(24)01809-9. Epub 2024 Oct 30.

DOI:10.1016/S0140-6736(24)01809-9
PMID:39488229
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11840673/
Abstract

BACKGROUND

In low-income and middle-income countries, individuals with major depressive disorder often do not receive screening and treatment. We assessed effectiveness and cost-effectiveness of an integrated care model for treating major depressive disorder in Malawi, accounting for two sets of positive externalities: household benefits and improvements in comorbidities.

METHODS

In this stepped-wedge, cluster-randomised, controlled trial, 14 health facilities in Neno District, Malawi, introduced screening, diagnosis, and treatment for people with major depressive disorder, using a stepped-care model of group Problem Management Plus and antidepressant therapy. Adults (ie, aged ≥18 years) residing in facility catchment areas, newly diagnosed with major depressive disorder, and actively enrolled in an integrated chronic care clinic were eligible for inclusion. People identified with high suicidal risk or psychotic symptoms were excluded. Health facilities were categorised into two strata (ie, health centres or secondary hospitals) and randomly allocated to one of five trial sequences, with intervention initiation staggered across sequences in 3-month periods. Participants were masked to trial sequence, data collectors were masked to treatment assignment, and the chief statistician was masked to treatment assignment until analysis. Services were delivered by counsellors and clinical officers at integrated chronic care clinics, and assessments took place at 3-month intervals over 27 months. Primary outcomes were changes in depressive symptom severity (measured with the Patient Health Questionnaire-9 [PHQ-9]), current depressive episode (PHQ-9 score of >10), and functioning (measured with the WHO Disability Assessment Schedule 2.0) over the 27-month period. Longitudinal mixed-effects regression analyses assessed outcomes from an intention-to-treat perspective. The trial was registered with ClinicalTrials.gov (NCT04777006) and is completed.

FINDINGS

Between Sept 1, 2021, and April 28, 2022, we conducted 15 562 screenings, resulting in 506 (3%) adults identified with major depressive disorder and 487 (3%) enrolled (395 [81%] women and 92 [19%] men). Assignment to IC3D corresponded to a 2·60-point (95% CI -3·35 to -1·86; d -0·61) reduction in depressive symptoms and 1·69-point (-2·73 to -0·65; -0·27) improvement in functioning, reflecting a reduced odds of depression after treatment roll-out (adjusted odds ratio 0·62, 95% CI 0·51 to 0·74).

INTERPRETATION

Integrated care for people with major depressive disorder and chronic health conditions is effective at reducing depressive symptoms, improving functioning, and reducing the odds of depression, and facilitates expansion of services through existing infrastructure.

FUNDING

National Institute of Mental Health.

摘要

背景

在低收入和中等收入国家,患有重度抑郁症的人往往得不到筛查和治疗。我们评估了马拉维一种综合护理模式治疗重度抑郁症的效果和成本效益,该模式考虑了两种正外部性:家庭效益和改善合并症。

方法

在这项阶梯式、整群随机对照试验中,马拉维恩诺区的 14 家卫生机构采用团体问题管理加抗抑郁治疗的阶梯式护理模式,对重度抑郁症患者进行筛查、诊断和治疗。有资格入组的是居住在设施覆盖范围内、新诊断出患有重度抑郁症且积极参加综合慢性护理诊所的成年人(即年龄≥18 岁)。有高自杀风险或精神病症状的人被排除在外。卫生机构分为两个层次(即卫生中心或二级医院),并随机分为五个试验序列之一,每隔 3 个月分期启动干预。参与者对试验序列不知情,数据收集者对治疗分配不知情,首席统计师在分析前对治疗分配不知情。服务由综合慢性护理诊所的顾问和临床医生提供,评估在 27 个月内每 3 个月进行一次。主要结局是在 27 个月期间抑郁症状严重程度(用患者健康问卷-9 [PHQ-9] 衡量)、当前抑郁发作(PHQ-9 评分>10)和功能(用世界卫生组织残疾评估量表 2.0 衡量)的变化。纵向混合效应回归分析从意向治疗的角度评估结果。该试验在 ClinicalTrials.gov(NCT04777006)注册,现已完成。

结果

在 2021 年 9 月 1 日至 2022 年 4 月 28 日期间,我们进行了 15562 次筛查,结果发现 506 名(3%)成年人患有重度抑郁症,487 名(3%)入组(395 名[81%]为女性,92 名[19%]为男性)。IC3D 的分配对应于抑郁症状降低 2.60 分(95%CI -3.35 至 -1.86;d=-0.61)和功能改善 1.69 分(-2.73 至 -0.65;-0.27),反映出治疗开展后抑郁的可能性降低(调整后的比值比 0.62,95%CI 0.51 至 0.74)。

解释

针对患有重度抑郁症和慢性健康状况的人的综合护理在降低抑郁症状、改善功能和降低抑郁可能性方面是有效的,并通过现有基础设施促进服务扩展。

资金来源

美国国立精神卫生研究所。

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