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临床试验/NCT01624935
NCT01624935已完成不适用

Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年7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
1
主要终点
Clinician Administered PTSD Scale (CAPS)

研究概览

简要总结

The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.

Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.

Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.

详细描述

Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.

研究设计

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

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

  • Age greater than 18 years;
  • diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
  • Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
  • Ability to give verbal informed consent

排除标准

  • Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
  • Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
  • drug and alcohol dependence

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS)

时间窗: baseline through week 24

CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

次要结局

  • Standard Clinical Interview for DSM IV Diagnosis (SCID)(baseline through week 24)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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