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临床试验/NCT00843700
NCT00843700已完成2 期

Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center

University of Rochester2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
162
试验地点
2
主要终点
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module

研究概览

简要总结

The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

详细描述

Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.

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

  • Age 18 or older
  • Current Major Depression
  • History of sexual abuse prior to age 18

排除标准

  • Bipolar disorder
  • Psychosis or schizophrenia
  • Active alcohol or substance abuse

结局指标

主要结局

Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module

时间窗: 20 months

次要结局

  • Beck Depression Inventory(20 months)
  • Hamilton Rating Scale for Depression(20 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Talbot

Associate Professor, Department of Psychiatry

University of Rochester

研究点 (2)

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