Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial,The Lancet Public Health

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Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial
The Lancet Public Health ( IF 25.4 ) Pub Date : 2024-01-02 , DOI: 10.1016/s2468-2667(23)00268-2
Nancy Byatt ₁ , Linda Brenckle ₂ , Padma Sankaran ₂ , Julie Flahive ₃ , Jean Y Ko ₄ , Cheryl L Robbins ₅ , Martha Zimmermann ₂ , Jeroan Allison ₃ , Sharina Person ₃ , Tiffany A Moore Simas ₆

Affiliation

Department of Psychiatry, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Obstetrics and Gynecology, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Psychiatry, UMass Memorial Health, Worcester, MA, USA; Department of Obstetrics and Gynecology, UMass Memorial Health, Worcester, MA, USA.
Department of Psychiatry, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Centers for Disease Control and Prevention, Atlanta, GA, USA; US Public Health Service, Commissioned Corps, Rockville, MD, USA.
Centers for Disease Control and Prevention, Atlanta, GA, USA.
Department of Psychiatry, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Obstetrics and Gynecology, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA; Department of Psychiatry, UMass Memorial Health, Worcester, MA, USA; Department of Obstetrics and Gynecology, UMass Memorial Health, Worcester, MA, USA.

Background

Perinatal depression is a common and undertreated condition, with potential deleterious effects on maternal, obstetric, infant, and child outcomes. We aimed to compare the effectiveness of two systems-level interventions in the obstetric setting—the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the PRogram In Support of Moms (PRISM)—in improving depression symptoms and participation in mental health treatment among women with perinatal depression.

Methods

In this cluster-randomised, active-controlled trial, obstetric practices across Massachusetts (USA) were allocated (1:1) via covariate adaptive randomisation to either continue participating in the MCPAP for Moms intervention, a state-wide, population-based programme, or to participate in the PRISM intervention, which involved MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. English-speaking women (aged ≥18 years) who screened positive for depression (Edinburgh Postnatal Depression Scale [EPDS] score ≥10) were recruited from the practices. Patients were followed up at 4–25 weeks of gestation, 32–40 weeks of gestation, 0–3 months postpartum, 5–7 months postpartum, and 11–13 months postpartum via telephone interview. Participants were masked to the intervention; investigators were not masked. The primary outcome was change in depression symptoms (EPDS score) between baseline assessment and 11–13 months postpartum. Analysis was done by intention to treat, fitting generalised linear mixed models adjusting for age, insurance status, education, and race, and accounting for clustering of patients within practices. This trial is registered with ClinicalTrials.gov, NCT02760004.

Findings

Between July 29, 2015, and Sept 20, 2021, ten obstetric practices were recruited and retained; five (50%) practices were randomly allocated to MCPAP for Moms and five (50%) to PRISM. 1265 participants were assessed for eligibility and 312 (24·7%) were recruited, of whom 162 (51·9%) were enrolled in MCPAP for Moms practices and 150 (48·1%) in PRISM practices. Comparing baseline to 11–13 months postpartum, EPDS scores decreased by 4·2 (SD 5·2; p<0·0001) among participants in MCPAP for Moms practices and by 4·3 (SD 4.5; p<0·0001) among those in PRISM practices (estimated difference between groups 0·1 [95% CI –1·2 to 1·4]; p=0·87).

Interpretation

Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms. This finding is important because the 4-point decrease in EPDS score is clinically significant, and MCPAP for Moms has a lower intensity and greater population-based reach than does PRISM.

Funding

US Centers for Disease Control and Prevention.

中文翻译：

两种系统级干预措施在产科环境中解决围产期抑郁症的有效性（PRISM）：主动对照整群随机试验

背景

围产期抑郁症是一种常见且治疗不足的疾病，对孕产妇、产科、婴儿和儿童结局具有潜在的有害影响。我们的目的是比较产科环境中两种系统级干预措施（针对妈妈的马萨诸塞州儿童精神病学准入计划 (MCPAP) 和妈妈支持计划 (PRISM)）在改善抑郁症状和参与心理健康治疗方面的有效性。患有围产期抑郁症的妇女。

方法

在这项整群随机、主动对照试验中，马萨诸塞州（美国）的产科实践通过协变量自适应随机化被分配（1:1），要么继续参加 MCPAP for Moms 干预，这是一项全州范围内的、以人群为基础的计划，或者参加 PRISM 干预措施，其中包括针对妈妈的 MCPAP 加上主动、多方面的产科实践水平干预措施以及密集的实施支持。从诊所招募了抑郁症筛查呈阳性（爱丁堡产后抑郁量表 [EPDS] 评分≥10）的英语女性（年龄≥18岁）。患者在孕4-25周、孕32-40周、产后0-3个月、产后5-7个月、产后11-13个月通过电话随访进行随访。参与者对干预措施不知情；调查人员没有蒙面。主要结局是基线评估和产后 11-13 个月之间抑郁症状（EPDS 评分）的变化。通过意向治疗、调整年龄、保险状况、教育和种族的广义线性混合模型以及考虑实践中患者的聚类来进行分析。该试验已在ClinicalTrials.gov注册， NCT02760004 。

发现

2015年7月29日至2021年9月20日期间，招募并保留了10名产科医师；五个 (50%) 诊所被随机分配给针对妈妈的 MCPAP，五个 (50%) 诊所被随机分配给 PRISM。 1265 名参与者接受了资格评估，并招募了 312 名 (24·7%) 参与者，其中 162 名 (51·9%) 参加了针对妈妈的 MCPAP 实践，150 名 (48·1%) 参加了 PRISM 实践。与产后 11-13 个月的基线相比，MCPAP 妈妈实践参与者的 EPDS 评分下降了 4·2 (SD 5·2; p<0·0001)，降低了 4·3 (SD 4.5; p<0·0001) PRISM 实践中的差异（0·1 组之间的估计差异 [95% CI –1·2 至 1·4]；p=0·87）。