Department of Obstetrics, Gynecology, and Reproductive Biology, Michigan State University College of Human Medicine, Flint, Michigan, USA
Division of Public Health, Michigan State University College of Human Medicine, Flint, Michigan, USA.
BMJ Open. 2022 Apr 19;12(4):e057747. doi: 10.1136/bmjopen-2021-057747.
This protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss.
A sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode.
The trial was approved by Michigan State University's Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request.
NCT04629599.
本方案描述了一项研究，旨在测试人际心理治疗（IPT）对围产期丧失（早期和晚期胎儿死亡和早期新生儿死亡）后重度抑郁症的疗效。围产期丧失与重度抑郁症和创伤后应激障碍（PTSD）的风险增加有关。围产期丧失带来了特殊的治疗需求。该试验将是首个针对围产期丧失后任何精神障碍进行的全面效能随机试验。
密歇根州弗林特和底特律地区的 274 名经历围产期丧失后出现重度抑郁发作的女性将被随机分配到IPT 治疗组或应对抑郁的对照组。我们预计 50%的样本会同时出现 PTSD。评估在基线、治疗中期（8 周）、治疗后（16 周）和随访（28 周）时进行。临床结局包括从重度抑郁发作中恢复的时间（主要结局）、抑郁症状、PTSD 症状和从 PTSD 中恢复的时间。其他结局包括社会支持、社会角色功能（包括对有存活子女的人进行父母功能）、幸福感、悲伤（包括复杂悲伤和过失信念）和对后续妊娠的恐惧。社会支持和悲伤被假设为 IPT 对从重度抑郁发作中恢复时间的影响的中介因素。
该试验得到密歇根州立大学生物医学机构审查委员会的批准。它有一个数据和安全监测委员会，并已提交给社区组织合作伙伴社区伦理审查委员会。书面操作程序概述了保护机密性、监测和记录不良事件以及保护参与者的方法。我们将与研究和临床社区、通过我们招募的社区组织分享研究结果，并向研究参与者提供结果。通过国家心理健康研究所数据档案，将可获得去标识数据集，并根据请求提供给合格的研究人员。
NCT04629599。
