Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss.
Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss.
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DOI：
10.1136/bmjopen-2021-057747
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发表时间：
2022-04-19
期刊：
影响因子：
2.9
通讯作者：
Zlotnick, Caron
中科院分区：
文献类型：
--
作者：
Johnson, Jennifer E.;Price, Ann B.;Sikorskii, Alla;Key, Kent D.;Taylor, Brandon;Lamphere, Susan;Huff, Christine;Cinader, Morgan;Zlotnick, Caron
该方案描述了一项测试人际心理治疗(IPT)对围产期丢失(早产儿和晚产儿死亡和早期新生儿死亡)后的严重抑郁障碍的疗效的研究。围产期损失与严重抑郁障碍和创伤后应激障碍(PTSD)的风险增加有关。围产期损失传达了特定的治疗需求。这项试验将是第一个完全有效的随机试验，用于治疗围产期丢失后的精神障碍。在密歇根州弗林特和底特律地区的274名 妇女中，她们在围产期丢失后经历了严重的抑郁发作，将被随机分为围产期丢失的IPT组或应对抑郁症的组。我们预计50%的样本会同时出现创伤后应激障碍。评估在基线、治疗中期(8周)、治疗后(16周)和随访(28周)进行。临床结果包括从主要抑郁发作中恢复的时间(主要)、抑郁症状、创伤后应激障碍症状以及从创伤后应激障碍中恢复的时间。其他结果包括社会支持、社会角色功能(包括有在世子女的父母的功能)、幸福、悲伤(包括复杂的悲痛和错误信念)以及对后续怀孕的恐惧。社会支持和悲伤是IPT影响严重抑郁发作后康复时间的假说中介变量。这项试验得到了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，并已提交给以社区为基础的组织伙伴社区道德审查委员会。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分享研究结果，并将向研究参与者提供研究结果。已确定的数据集将通过国家精神卫生数据档案馆提供，并应要求提供给合格的调查人员。NCT04629599。
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.
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