Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase (MITT)
Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
研究概览
详细说明
This research project consists of two phases that are designed, in sequence, to adapt standard collaborative care depression treatment to the unique needs of low-income depressed postpartum women and to the pediatric setting where women will receive the treatment. These adaptations, in turn, are designed to improve maternal engagement in and adherence to depression treatment, the primary outcomes at this early stage of intervention development. Phase I is the initial pilot project in which the model will be developed. We will 1) adapt standard collaborative care depression models into the Mother-Infant Treatment Team (MITT) intervention and develop a procedure manual based on maternal and provider input, 2) pilot the MITT intervention with 10 depressed mothers to test the feasibility of implementing the model, and 3) evaluate the experiences of participating mothers and providers to revise and finalize MITT processes and procedures.
Phase II will be an open label trial of MITT to determine whether MITT is associated with improved maternal engagement and adherence to depression treatment.
We will pilot MITT with 10 mothers to determine the feasibility of implementing MITT. We will collect recruitment and logistical feasibility measures. We will also determine engagement and adherence rates to treatment as well as the effort required to engage women in treatment.
We will determine mothers' and providers' perceptions of their experiences with MITT and will use all of this information to revise the MITT protocol in preparation for Phase II.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Rochester、New York、美国、14642
- University of Rochester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Mothers of infants 12 months of age or younger who present to the Pediatric Practice at Golisano Children's Hospital
- Women who are 18 years of age or older
- Mothers who understand and speak English sufficiently to participate in therapy with an English speaking provider
- Have a current score of > 10 on the EPDS
- Provide written informed consent
- Meet criteria for unipolar major depressive disorder.
Exclusion Criteria:
Women who:
- do not speak or understand English well enough to participate in the therapy with an English speaking provider
- are under 18 years of age
- children are not cared for at the Pediatric Practice at the Golisano Children's Hospital
- are actively psychotic, suicidal or homicidal,
- require treatment (including additional psychotropic medications) not provided by MITT,
- in the judgment of the MITT psychiatric provider require a higher level of psychiatric care (i.e. partial hospitalization, hospitalization, intensive case management),
- are in active counseling or psychotherapy,
- are under the care of a psychiatric provider and/or are receiving active treatment for depression including light therapy, ECT, or antidepressants
- are receiving psychotropic medications not allowed in this study,
- previously participated in and/or were terminated from the study,
- have a diagnosis of bipolar disorder, schizophrenia, other psychotic disorder or alcohol/substance use disorder, and/or
- have a medical condition or are taking medications that are contraindicated for sertraline
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MITT
Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach.
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This is a treatment team approach that allows for outreach.
The clinical team will be a nurse practitioner of psychiatry and a social worker.
The nurse practitioner will provide either interpersonal psychotherapy, sertraline or both as indicated.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Treatment Engagement
大体时间：6 weeks
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6 weeks
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Treatment Adherence
大体时间：18 weeks
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18 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Treatment Response
大体时间：12 weeks
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12 weeks
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Treatment Remission
大体时间：12 weeks
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12 weeks
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Maternal functional assessment
大体时间：12 weeks
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12 weeks
|
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Maternal healthcare utilization
大体时间：18 weeks
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18 weeks
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Infant healthcare utilization
大体时间：18 weeks
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18 weeks
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合作者和调查者
调查人员
- 首席研究员：Linda H Chaudron, MD, MS、University of Rochester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.