Identification and Therapy of Postpartum Depression
研究概览
详细说明
Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
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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:
- 4-6 weeks postpartum
- English-speaking
- Score of at least 10 on the Edinburgh Postnatal Depression Scale
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder or psychotic episode
- Active substance abuse within 6 months prior to study entry
- Has not received obstetrical care
- History of a suicide attempt within 6 months of study entry
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:塔乌
参与者将照常接受治疗
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Participants receive treatment as usual for postpartum depression.
Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum.
At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms.
Women are also given phone contact numbers for the research program.
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实验性的:DCM
Participants will receive care management for postpartum depression
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Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care.
In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available.
Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well.
Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum.
They also receive information about community and health plan resources available for women with depression.
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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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Depressive symptoms, social functioning, and health
大体时间:Measured at Months 3, 6, and 12 postpartum
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Measured at Months 3, 6, and 12 postpartum
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Preferences for depression treatment
大体时间:Measured at baseline and Month 12
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Measured at baseline and Month 12
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合作者和调查者
调查人员
- 首席研究员:Katherine L. Wisner, MD, RN、University of Pittsburgh
出版物和有用的链接
一般刊物
- Wisner KL, Sit DKY, McShea M, Luther JF, Eng HF, Dills JL, Moses-Kolko EL, Wisniewski SR. Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Nov-Dec;78(9):1369-1375. doi: 10.4088/JCP.15m10563.
- Clark CT, Sit DK, Driscoll K, Eng HF, Confer AL, Luther JF, Wisniewski SR, Wisner KL. DOES SCREENING WITH THE MDQ AND EPDS IMPROVE IDENTIFICATION OF BIPOLAR DISORDER IN AN OBSTETRICAL SAMPLE? Depress Anxiety. 2015 Jul;32(7):518-26. doi: 10.1002/da.22373. Epub 2015 Jun 8.
- Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
- Sit D, Seltman H, Wisner KL. Seasonal effects on depression risk and suicidal symptoms in postpartum women. Depress Anxiety. 2011 May;28(5):400-5. doi: 10.1002/da.20807. Epub 2011 Mar 4.
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.
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