Sober Network IPT for Perinatal Women with comorbid substance use and depression

描述（由申请人提供）：患有共同发生的物质使用障碍和重度抑郁症（SUD-MDD）的围产期妇女是公共卫生问题，因为除了与这些疾病相关的情绪困扰、损害和不良健康影响外，她们还面临许多新生儿和产科风险。尽管在围产期女性中与SUD和MDD相关的严重发病率，尽管需要针对特定人群的治疗来解决与女性生命的这一时期相关的独特挑战，但实际上没有针对患有SUD-MDD的围产期女性的特定需求的基于外科学的治疗。在这项治疗开发补助金中，我们建议对一种新的12周个体治疗进行试点测试，用于患有SUD-MDD的围产期妇女的清醒网络IPT，其重点是在更广泛的人际心理治疗（IPT）框架内对SUD的网络支持策略;围产期MDD的治疗选择。清醒的网络支持在理论上与IPT一致，并且已被确定为许多有效SUD治疗的经验支持的变化机制。该治疗开发补助金的目的是（a）将SUD的网络支持策略整合到IPT框架中，为患有SUD-MDD的围产期女性创建清醒网络IPT，以及（B）在妊娠期间或产后3个月内符合SUD-MDD标准的50名女性样本中进行随机试点试验，以证明拟议招募方法和研究设计的可行性和可接受性，治疗师培训方法和提供清醒网络IPT治疗。我们将评估清醒网络IPT相对于增强剂量匹配治疗作为辅助治疗将导致以下结局的程度：3个月随访期间重度饮酒/药物使用天数减少，治疗后和3个月随访时抑郁症状减少（主要）以及清醒支持和社会支持改善（次要）。我们将探讨在后续试验中使用胎儿、新生儿和婴儿结局以及参与健康预防作为次要结局的可行性。作为该R34探索性研究项目的结果，我们将IPT改编为Sober Network IPT，这是一种针对患有SUD-MDD的围产期女性的新型治疗方法，测试了其可行性，可接受性和初步疗效，这将为未来的R 01临床试验奠定基础。由于我们提出的研究将在临床环境中与社区治疗师/提供者以及患有多种问题和一系列临床困难的患者合作进行，因此从长远来看，我们提出的研究计划将为患有SUD-MDD的围产期女性的临床护理提供信息，并有可能传播到治疗患有SUD-MDD的围产期女性的其他社区机构;具有重大公共卫生意义的临床问题的未得到充分服务的妇女。此外，如果发现Sober Network IPT在我们的脆弱目标人群中有效，我们预计它可能会为更异质的SUD-MDD人群带来希望。

DESCRIPTION (provided by applicant): Perinatal women with co-occurring substance use disorder and major depressive disorder (SUD-MDD) are of public health concern because they face numerous neonatal and obstetrical risks in addition to the emotional distress, impairment, and adverse health effects associated with these disorders. Despite the serious morbidity associated with both SUD and MDD in perinatal women and despite the need for population-specific treatments that address the unique set of challenges associated with this period of a women's life, there are virtually no empirically-based treatments that target the specific needs of perinatal women with SUD-MDD. In this treatment development grant, we propose to pilot test a novel 12-week individual treatment, Sober Network IPT for perinatal women with SUD-MDD, which focuses on network support strategies for SUD within a broader Interpersonal Psychotherapy (IPT) framework; the treatment of choice for perinatal MDD. Sober network support is theoretically consistent with IPT and has been identified as an empirically supported mechanism of change of many efficacious SUD treatments. The purposes of this treatment development grant are to (a) integrate network support strategies for SUD into an IPT framework to create Sober Network IPT for perinatal women with SUD-MDD, and (b) conduct a randomized pilot trial in a sample of 50 women who meet criteria for SUD-MDD during pregnancy or within 3 months postpartum to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the therapist training methods and of delivering the Sober Network IPT treatment. We will evaluate the extent to which Sober Network IPT relative to Enhanced Dose-Matched Treatment as Usual will result in the following outcomes: fewer heavy drinking/drug using days through the 3 month follow-up, reduced depressive symptoms at post-treatment and 3 month follow-up (primary) and improved sober support and social support (secondary). We will explore the feasibility of using fetal, neonatal and infant outcomes and engagement in health prevention as secondary outcomes in a subsequent trial. As a result of this R34 Exploratory Research Project, we will have adapted IPT into Sober Network IPT, a novel treatment approach for perinatal women with SUD-MDD, tested its feasibility, acceptability, and initial efficacy, which will lay the groundwork future R01 clinical trials. Because our proposed research will be conducted in a clinical setting in collaboration with community therapists/providers, and with patients with multiple problems and a range of clinical difficulties, our proposed program of research, from a longer term perspective, will inform the clinical care of perinatal women with SUD-MDD and has the potential for dissemination to other community agencies that treat perinatal women with SUD-MDD; underserved women with clinical concerns that are of great public health significance. Furthermore, if Sober Network IPT is found to be efficacious in our vulnerable target population, we anticipate that it could hold promise for a more heterogeneous SUD-MDD population.