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

描述（由申请人提供）：围产期妇女同时患有物质使用障碍和重度抑郁症（SUD-MDD）是公共卫生关注的问题，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。尽管围产期妇女与SUD和MDD相关的发病率很高，尽管需要针对特定人群的治疗来解决与妇女生命中这一时期相关的独特挑战，但实际上没有基于经验的治疗方法来针对围产期患有SUD-MDD的妇女的特定需求。在这项治疗发展资助中，我们建议试点测试一种新的为期12周的个体治疗，清醒网络IPT，用于围产期患有SUD- mdd的妇女，该治疗侧重于在更广泛的人际心理治疗（IPT）框架内对SUD的网络支持策略；围产期重度抑郁症的治疗选择。清醒网络支持在理论上与IPT是一致的，并且已被确定为许多有效的SUD治疗变化的经验支持机制。这项治疗发展资助的目的是(a)将SUD的网络支持策略整合到IPT框架中，为患有SUD- mdd的围产期妇女创建清醒网络IPT，以及(b)在50名怀孕期间或产后3个月内符合SUD- mdd标准的妇女样本中进行随机试点试验，以证明拟议的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相对于常规强化剂量匹配治疗的程度：通过3个月的随访减少重度饮酒/吸毒天数，治疗后和3个月随访（主要）减轻抑郁症状，改善清醒支持和社会支持（次要）。我们将在后续试验中探讨将胎儿、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R34探索性研究项目的结果，我们将把IPT应用于醒酒网络IPT，这是一种治疗围产期女性sd - mdd的新方法，测试其可行性、可接受性和初步疗效，为未来的R01临床试验奠定基础。由于我们拟议的研究将在临床环境中与社区治疗师/提供者合作进行，并且患者有多种问题和一系列临床困难，因此我们拟议的研究计划，从长远来看，将为患有SUD-MDD的围产期妇女的临床护理提供信息，并有可能传播到治疗患有SUD-MDD的围产期妇女的其他社区机构；对公共卫生具有重大意义的临床问题的得不到充分服务的妇女。此外，如果我们发现Sober Network IPT在我们脆弱的目标人群中是有效的，我们预计它可以为更异质的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.