Development of Mental Health Treatment for Obstetric Fistula Patients

描述（由申请人提供）： 产科瘘管是膀胱或直肠与阴道之间的一个洞，当梗阻性分娩不能通过剖宫产缓解时，就会发生，并导致无法控制的尿液和/或粪便泄漏。产科瘘管病的唯一治疗方法是手术修复。多项研究记录了产科瘘管病的社会和心理影响，包括社会孤立、耻辱、抑郁和心理健康功能障碍。手术修复环境可以是一个机会之窗，以解决与瘘管生活积累的心理健康困扰。然而，迄今为止，还没有干预研究评估了辅助瘘管病患者心理愈合的辅助疗法。这项拟议的研究旨在通过开发和试点测试一种理论上知情的心理健康干预措施，为接受产科手术修复的妇女填补这一空白。 坦桑尼亚莫希的KCMC医院。本研究有三个具体目的：1）开发护士提供的心理健康干预，建立在应对和认知行为疗法的理论基础上，2）评估在KCMC瘘管病房实施干预的可行性和可接受性，考虑：干预保真度、患者满意度、提供者反馈和交付成本，3）通过比较30名接受实验性干预的妇女与30名接受标准护理咨询的妇女的即时和短期结果，评估干预的有效性，检查主要结果的差异（抑郁症，创伤后应激障碍和躯体症状）和次要结果（应对，感知耻辱，社会支持，社会参与，与提供者合作的功效，遵守临床建议和重返社会）。拟议的研究直接回应了NIH的具体需求，因为它扩大了“改善产科瘘管病妇女社会成果的证据基础”，并制定了补充现有当地护理的“可持续干预”（PA-11-143）。在本研究完成时，我们希望我们将有一个结构化的干预课程和支持性的初步数据，以告知R 01应用程序对干预进行多中心评估，如果 这些方法有效，可在国际上传播给瘘管修补诊所。

DESCRIPTION (provided by applicant): Obstetric fistula is a hole between the bladder or rectum and the vagina, which develops when obstructed labor is not relieved by cesarean section and results in uncontrollable leaking of urine and/or feces. The only cure for obstetric fistula is surgical repair. Multiple studies have documented the social and psychological impact of obstetric fistula, which includes social isolation, stigma, depression, and mental health dysfunction. The surgical repair setting can be a window of opportunity to address the accumulated mental health distress of living with a fistula. However, to date no intervention studies have evaluated empirically-supported therapies to assist in psychological healing among fistula patients. The proposed study aims to fill this gap by developing and pilot-testing a theoretically informed mental health intervention for women receiving surgical repair for obstetric fistula at KCMC Hospital in Moshi, Tanzania. The study has three specific aims: 1) To develop the nurse-delivered mental health intervention, built on theories of coping and cognitive behavioral therapy, 2) To assess feasibility and acceptability of implementing the intervention in the KCMC fistula ward, considering: intervention fidelity, patient satisfaction, provider feedback and cost of delivery, 3) To assess effectiveness of the intervention by comparing immediate and short term outcomes in 30 women who receive the experimental intervention with 30 women receiving the standard of care counseling, examining differences in primary outcomes (depression, PTSD and somatic symptoms) and secondary outcomes (coping, perceived stigma, social support, social participation, efficacy to engage with providers, adherence to clinical recommendations and social reintegration). The proposed research directly responds to the needs specified by NIH because it expands the "evidence base for improving social outcomes" of women with obstetric fistula and develops a "sustainable intervention" that complements existing local care (PA-11-143). At the completion of this study, it is our expectation that we will have a structured intervention curriculum and supportive preliminary data to inform an R01 application to conduct a multi-site evaluation of the intervention, which, if effective, can be disseminated to fistula repair clinics internationally.