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临床试验/NCT00607815
NCT00607815已完成不适用

A Comparison of CPT vs PCT for Veterans

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2009年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
2
主要终点
Clinician Administered PTSD Scale

研究概览

简要总结

The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.

详细描述

The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.

CPT has been shown to be effective in treating trauma survivors in several treatment outcome studies, but utility with Veterans has only been examined with male Veterans in one small pilot study. In addition CPT has never been compared to a treatment as usual or supportive psychotherapy condition to control for the specific and nonspecific elements of treatment. Although Cognitive Processing Therapy is one of the main treatment modalities at several VA's, including Cincinnati, it has never been compared to PCT, nor has it been used in a large, randomized study of male OEF/OIF Veterans. It is hypothesized that individual receiving CPT will show a larger reduction in posttraumatic stress disorder and related symptoms than those individuals receiving PCT.

All male OEF/OIF Veterans will be screened for their appropriateness for the study by phone screen and then by an assessment technician. The Veteran will be assessed at pre, post, 3-month, and 1-year follow-up. The assessment technicians will be blind to the participant's condition. CPT is a 12 week long individual psychotherapy treatment shown to be effective at reducing PTSD and related symptoms for survivors of various types of traumas, including combat. PCT is a supportive counseling treatment that has been utilized as an alternative to waitlist control in VA cooperative studies of PTSD.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • memory of the trauma;
  • able to read/write;
  • must be stable on medication for 3 months

排除标准

  • Psychosis;
  • suicidal/homicidal intent;
  • alcohol/substance dependence;
  • no memory of the trauma

研究组 & 干预措施

Cognitive Processing Therapy

Active Comparator

Cognitive Processing Therapy

干预措施: Cognitive Processing Therapy (Behavioral)

Present Centered Therapy

Active Comparator

Present Centered Therapy

干预措施: Present Centered Therapy (Behavioral)

结局指标

主要结局

Clinician Administered PTSD Scale

时间窗: Post-treatment, at 3 months and 1 year

Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.

PTSD Checklist (PCL)

时间窗: post-treatment, at 3 months and 1 year

17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed

次要结局

  • Beck Depression Inventory - II (BDI-II)(post-treatment, at 3 months and 1 year)
  • State-Trait Anger Scale (STAXI)(post-treatment, at 3 months and 1 year)
  • State-Trait Anxiety Scale(post-treatment, at 3 months and 1 year)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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