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临床试验/NCT01685294
NCT01685294已完成3 期

Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

Brown University10 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
181
试验地点
10
主要终点
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months

研究概览

简要总结

This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.

详细描述

The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
  • Expectation of at least 6 months of incarceration at baseline interview
  • Incarcerated for at least 4 weeks

排除标准

  • Lifetime:
  • Bipolar disorder
  • Psychotic disorder
  • Are imminently suicidal
  • Cannot understand English well enough to understand the consent form or assessment instruments when read aloud

结局指标

主要结局

Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months

时间窗: 3 Months from Baseline

次要结局

  • Change from Baseline in Suicidality at 6 Months(6 Months from Baseline)
  • Cost-effectiveness(6 months post-baseline)
  • Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months(6 Months from Baseline)
  • Change from Baseline in Suicidality at 3 Months(3 Months from Baseline)
  • Change from Baseline in In-Prison Functioning at 3 Months(3 Months from Baseline)
  • Change from Baseline in In-Prison Functioning at 6 Months(6 Months from Baseline)

研究者

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

Dr. Jennifer Johnson

Associate Professor (Research), Department of Psychiatry and Human Behavior

Brown University

研究点 (10)

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