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Multidisciplinary Model of Nurse Midwife

2015年8月5日 更新者：Barbara Posmontier、Drexel University

Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression

HYPOTHESES:

The hypotheses are that:

  1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
  2. women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners
  3. women with postpartum depression will be more satisfied with their care than women in the group that was referred to a mental health center.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:

  1. The (a) feasibility, (b) acceptability and (c) safety of a psychological intervention (Interpersonal Psychotherapy [IPT]) provided by nurse midwives in collaboration with a mental health team (psychiatrist team leader and a licensed social worker) for treatment of PPD in a pilot two-armed non-randomized clinical trial.
  2. The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner

  3. The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in

    1. Improving the general level of maternal functioning
    2. Specific improvement in marital adjustment
    3. Increase in maternal infant bonding

This pilot study is the first step in developing an intervention to decrease depressive symptoms, improve functioning, improve interpersonal relationships between mother and spouse and infant, improve access to care, and improve treatment engagement among postpartum women diagnosed with PPD. The intervention will be cost-effective, brief and acceptable to both patients and nurse midwives for incorporation into current midwifery practice. If the IPT program is found to be feasible, acceptable and safe with preliminary evidence of efficacy, a postpartum IPT manual for advanced practice nurses will be finalized in order to test whether other advanced practice nurses such as pediatric nurse practitioners and family nurse practitioners can also safely and effectively administer IPT in a full-scale randomized clinical trial

研究类型

介入性

注册 (实际的)

61

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Pennsylvania
      • Phila、Pennsylvania、美国、19102
        • Drexel University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 45年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 6 to 24 weeks postpartum
  • 16 years and older
  • English-speaking
  • Have access to a telephone
  • Consents to enter the trial
  • Postpartum onset of postpartum depression
  • Current use of antidepressant medication as long as dose does not have to be adjusted by subject's healthcare provider during clinical trial

Exclusion Criteria:

  • Infant complications requiring medical care beyond 6 weeks postpartum
  • Infant birth defects
  • Infant being placed for adoption by 6 weeks postpartum
  • Maternal mental retardation
  • Current use of antidepressant medication that requires dosage adjustment by subject's healthcare provider during clinical trial
  • Diagnosis of depression prior to postpartum period
  • Active substance or alcohol abuse or dependence
  • Active suicidality, homicidality, or current psychosis as assessed by the MINI
  • Disabling pain that interferes with the ability to carry out activities of daily living
  • Concurrent serious medical co-morbidities (e.g. active lupus, multiple sclerosis, severe cardiac disease severe hypertension, cancer, etc).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
行为的：CNM Interpersonal Psychotherapy
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
有源比较器：Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
行为的：Treatment as Usual
Treatment as Usual is psychotherapy provided by a mental health provider

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hamilton Rating Scale for depression
大体时间：12 weeks
Measure of depression severity
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Global Assessment of functioning
大体时间：12 weeks
Measure of functional status
12 weeks
Dyadic Adjustment Scale
大体时间：12 weeks
Measure of dyadic adjustment of marital couple
12 weeks
Social Support Questionnaire
大体时间：12 weeks
Measure of improvement in social support
12 weeks
Client Satisfaction Questionnaire
大体时间：12 weeks
Measure of client satisfaction with midwife counseling
12 weeks
Edinburgh Postnatal Depression Scale
大体时间：12 weeks
Measure of severity of postpartum depression
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Drexel University

调查人员

  • 首席研究员：Barbara E Posmontier, PHD、Drexel University
  • 首席研究员：Richard Neugebauer, PhD、Columbia University
  • 首席研究员：Rita Shaughnessy, PhD, MD、Drexel University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年7月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2010年5月24日

首先提交符合 QC 标准的

2013年8月30日

首次发布 (估计)

2013年9月5日

研究记录更新

最后更新发布 (估计)

2015年8月7日

上次提交的符合 QC 标准的更新

2015年8月5日

最后验证

2015年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 18981

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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