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一项针对“提前开端计划”中预防孕产妇抑郁策略的疗效:一项随机临床试验。

Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial.

作者信息

Silverstein Michael, Diaz-Linhart Yaminette, Cabral Howard, Beardslee William, Hegel Mark, Haile Winta, Sander Jenna, Patts Gregory, Feinberg Emily

机构信息

Department of Pediatrics, Boston Medical Center, Boston, Massachusetts2Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts.

Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.

出版信息

JAMA Psychiatry. 2017 Aug 1;74(8):781-789. doi: 10.1001/jamapsychiatry.2017.1001.

DOI:10.1001/jamapsychiatry.2017.1001
PMID:28614554
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5710555/
Abstract

IMPORTANCE

Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy.

OBJECTIVE

To determine the efficacy of a depression prevention strategy embedded in Head Start.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016.

INTERVENTIONS

Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119).

MAIN OUTCOMES AND MEASURES

Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders.

RESULTS

Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants compared with 0.88 (1.37) among usual service participants (aIRR, 0.39; 95% CI, 0.21-0.75). However, no difference was observed among those with higher-level baseline symptoms (mean [SD] elevations, 2.06 [1.92] for PSE and 2.00 [1.91] for usual service; aIRR, 1.10; 95% CI, 0.67-1.80). Analysis of symptom scores followed the same pattern, with an adjusted mean reduction of 1.33 (95% CI, 0.36-2.29) among participants with lower-level baseline symptoms.

CONCLUSIONS AND RELEVANCE

The PSE intervention is efficacious in preventing depressive symptom episodes and performs optimally among those with initial low-level symptoms. Additional effectiveness studies in Head Start are necessary to develop meaningful public health programs.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01298804.

摘要

重要性

低收入和少数族裔母亲患抑郁症的比例过高,且难以获得治疗服务。在可及的社区场所制定预防策略是一项潜在的重要公共卫生策略。

目的

确定在“启智计划”(Head Start)中实施的抑郁症预防策略的效果。

设计、场所和参与者:这项随机临床试验于2011年2月15日至2016年5月9日在6个为处于或低于联邦贫困水平家庭服务的“启智计划”机构进行。参与者包括有情绪低落、快感缺失或抑郁症病史但目前未处于重度抑郁发作的母亲。对参与者进行为期12个月的随访,并采用盲法进行结局评估。最终随访于2016年5月9日完成。

干预措施

参与者被随机分为问题解决教育(PSE)干预组(n = 111)或常规“启智计划”服务组(n = 119)。

主要结局和测量指标

主要结局是问题解决能力和抑郁症状。为了了解症状的慢性和严重程度,每两个月进行一次抑郁症状快速清单评估,并比较各组临床显著症状加重的发生率。其次,使用《精神疾病诊断与统计手册》第四版轴I障碍结构化临床访谈来评估重度抑郁发作的情况。

结果

在230名参与者中,152名(66.1%)为西班牙裔,平均(标准差)年龄为31.4(7.3)岁。在223名提供随访数据的参与者中进行的意向性分析发现,各组之间在问题解决能力方面没有差异。PSE干预组抑郁症状加重的平均(标准差)次数为0.84(1.39),而常规服务组为1.12(1.47)(调整后的发病率比[aIRR],0.60;95%置信区间,0.41 - 0.90)。在根据基线抑郁症状分层的分析中,PSE对基线症状较轻的参与者有预防作用,PSE干预组症状加重的平均(标准差)次数为0.39(0.84),而常规服务组为0.88(1.37)(aIRR,0.39;95%置信区间,0.21 - 0.75)。然而,在基线症状较重的参与者中未观察到差异(PSE组症状加重的平均[标准差]次数为2.06[1.92],常规服务组为2.00[1.91];aIRR,1.10;95%置信区间,0.67 - 1.80)。症状评分分析也遵循相同模式,基线症状较轻的参与者调整后的平均症状减轻为1.33(95%置信区间,0.36 - 2.29)。

结论及相关性

PSE干预在预防抑郁症状发作方面有效,且在初始症状较轻的人群中效果最佳。有必要在“启智计划”中开展更多有效性研究,以制定有意义的公共卫生项目。

试验注册

clinicaltrials.gov标识符:NCT01298804。

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