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Treatment of Depression in Mothers in Home Visitation (MIDIS)

This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted evidence-based treatment for depressed mothers participating in home visitation, with typical home visitation in which treatment may be obtained in the community. Mothers will be identified using a two step process consisting of administration of a screen and subsequent diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and control conditions. A comprehensive assessment of depression and related areas of functioning will be administered at pre-treatment, post-treatment, and 3 month follow-up. It is hypothesized that IH-CBT will lead to broad and durable gains in mood and social support relative to those in typical home visitation.

研究概览

详细说明

This study involves the development and preliminarily testing of In-Home Cognitive Behavioral Therapy (IH-CBT), a psychological treatment grounded in the cognitive model but adapted for administration in conjunction with home visitation. IH-CBT is designed to (1) use the techniques and approaches of CBT which have received strong empirical support, (2) be implemented in the home setting, (3) meet the needs of young postpartum mothers in their first year of home visitation, and (4) be seamlessly integrated with home visitation to maximize the likelihood of recovery from depression, prevent relapse, and increase of the benefits of home visitation. IH-CBT will be delivered by trained therapist who will provide 15 treatment sessions followed by a 1 month booster session. A small-scale randomized clinical trial will be conducted contrasting IH-CBT delivered in conjunction with home visitation and home visitation alone ("typical home visitation"-THV). Mothers in the THV condition will be able to obtain treatment in the community if they choose.

Mothers will be identified based on obtaining a score of ≥12 on the Edinburgh Perinatal Depression Screen administered by home visitors at 3 months postpartum. Final eligibility will be determined based on subsequently obtaining a diagnosis of Major Depressive Disorder (MDD) using the SCID. A comprehensive assessment of depression, other psychiatric symptoms, social support and network, and parenting and child adjustment will be administered at pre-treatment, post-treatment, and 3 month follow-up. Ratings of MDD at post-treatment and follow-up will be conducted by clinicians blind to condition.

The following hypotheses will be tested:

Hypothesis 1. Mothers in IH-CBT will report greater reductions in self-reported and clinician-rated depression at post-treatment and follow up relative to THV.

Hypothesis 2. Mothers in IH-CBT will report improvements in overall functioning, social support, social network, and general psychiatric symptomatology at post-treatment and follow up relative to IH-CBT.

Hypothesis 3. Mothers who recover from depression at post-treatment will report improvements in parenting and child adjustment relative to those who do not recover.

研究类型

介入性

注册 (实际的)

93

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

    • Ohio
      • Cincinnati、Ohio、美国、45229
        • Cincinnati Children's Hospital Medical Center

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:

  • first-time mother participating in home visitation program
  • enrolled in home visitation program for at least 2 months
  • 16 years of age or older
  • score of 12 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
  • diagnosis of Major Depressive Disorder using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders
  • English speaking

Exclusion Criteria:

  • lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder
  • history of psychosis
  • current substance dependence
  • current antidepressant use or other mood altering medications and/or current involvement in psychotherapy

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:In-Home Cognitive Behavioral Therapy
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation. IH-CBT is delivered by a masters level therapist. It consists of 15 weekly sessions and 1 booster session provided 1 month after the 15th session.
其他名称:
  • IH-CBT
无干预:typical home visitation
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.

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
maternal depression
大体时间:8 months
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
8 months

次要结果测量

结果测量
措施说明
大体时间
parenting and child social/emotional functioning
大体时间:8 months
Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
8 months

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。

调查人员

  • 首席研究员:Robert T. Ammerman, Ph.D.、Children's Hospital Medical Center, Cincinnati

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2006年10月1日

初级完成 (实际的)

2010年10月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2010年10月14日

首先提交符合 QC 标准的

2010年10月14日

首次发布 (估计)

2010年10月15日

研究记录更新

最后更新发布 (估计)

2013年3月18日

上次提交的符合 QC 标准的更新

2013年3月15日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R34MH073867 (美国 NIH 拨款/合同)

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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