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临床试验/NCT00348036
NCT00348036已完成不适用

Trauma Interventions for Low-income Women in Primary Care

Georgetown University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2008年9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
27
试验地点
2
主要终点
PTSD checklist

研究概览

简要总结

This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.

详细描述

The aim of this study is to assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder (PTSD) following interpersonal trauma exposure. Group participants will be recruited from public sector/safety net primary care clinics. Study participants will be randomized to immediate or delayed treatment. Participants in both conditions will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. Participants will be free to attend any of the sessions they missed during the first group when the group repeats. Participants in the delayed condition will be able to attend the groups after a 12-week waiting period. Assessments of PTSD, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. Gift cards will be sent to the women for completing each of the assessments.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Exposure to an interpersonal traumatic event
  • Diagnosis of depression or PTSD (threshold or subthreshold)
  • Functional literacy

排除标准

  • Apparent incoherence or disorientation
  • Apparent intoxication at recruitment
  • Hearing impairment

结局指标

主要结局

PTSD checklist

时间窗: Measured at baseline, Week 12, and Month 6

Hamilton Depression Inventory

时间窗: Measured at baseline, Week 12, and Month 6

次要结局

  • Inventory of Interpersonal Problems(Measured at baseline, Week 12, and Month 6)
  • Health care utilization(Measured at baseline, Week 12, and Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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