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临床试验/NCT00292903
NCT00292903已完成不适用

Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Depressive symptoms

研究概览

简要总结

This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.

详细描述

Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.

Participants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Between 8 and 32 weeks of gestation at time of study entry
  • A score above 12 on the Edinburgh Postnatal Depression Scale
  • Speaks English
  • Resides in the Pittsburgh, PA, area
  • Access to a household telephone

排除标准

  • Currently receiving treatment for depression (i.e., medication or psychotherapy)
  • History of a prior manic episode
  • Alcohol or drug abuse or dependence within 6 months of study entry
  • Psychotic disorder or organic mental disorder
  • Suicidal, homicidal, or requires hospitalization
  • Severe sexual and/or physical aggression in relationship with partner or husband
  • Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease
  • Severe cognitive deficits that would prevent treatment with psychotherapy

结局指标

主要结局

Depressive symptoms

时间窗: Measured throughout treatment and at Months 2 and 6 postpartum

Treatment attendance

时间窗: Measured at Week 12

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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