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Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans

2014年2月20日 更新者:Diane T. Castillo, Ph.D.、New Mexico VA Healthcare System

Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD

The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of evidence-based therapies in comparison to a wait-list control and evaluate the relative contribution of exposure, cognitive, and skills blocks of treatment in a 16-session manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1: Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD symptoms than the skills component. Significant results will establish the efficacy of a group format for evidence-based treatments for all veterans with a PTSD diagnosis. An ancillary part of the study is to examine initial neuropsychological presentation in this population and possible changes that may occur as the result of treatment.

研究概览

地位

完全的

详细说明

OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the relative contribution of each of three treatment components in a manualized treatment group in a sample of OIF/OEF female PTSD veterans. HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD veterans will show reductions in PTSD symptoms and improvement in general functioning after participation in a structured group treatment compared to a wait-list control group. Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD symptoms than the skills component. RESEARCH DESIGN/BACKGROUND: Based on studies with male combat veterans, female civilian rape victims, and female veterans, therapies most effective for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive restructuring (4), with less improvement found in other treatments, such as relaxation and assertiveness training (5). Most examinations of PTSD treatments have been conducted in an individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital PTSD programs are conducted in a group format (6). It is critical to determine if these therapies work in a group setting, as only one study (7) found no differences in exposure therapy compared to a support group. In a comprehensive manualized group treatment protocol (8) exposure therapy provided in a group was found effective (9). The aim of the present study is to establish the effectiveness of exposure therapy, among other evidence-based therapies, in a well designed randomized study. METHODOLOGY: Castillo's (8) manualized group treatment protocol for female veterans with PTSD will be modified into a 16-week treatment group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks. Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which will be reassessed and offered the study treatment. Oversampling will result in 72 subjects in the active treatment arm. Subjects will be reassessed upon completion of treatment or wait-list, at 3, and 6 months following treatment. All treatment groups will include three female OIF/OEF veterans positive for PTSD. The treatment blocks will be varied into six possible orders to control for order effects and the PTSD Symptom Checklist will be administered after each treatment block. Data will be collected for three years. CLINICAL RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based treatments in a manualized treatment group for all veterans with a PTSD diagnosis. FINDINGS: Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a group setting.

研究类型

介入性

注册 (实际的)

86

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Mexico
      • Albuquerque、New Mexico、美国、87108
        • New Mexico VA Health Care System

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Diagnosis of PTSD
  • Iraq or Afghanistan female Veteran
  • Psychiatry stability (no suicide, homicide)
  • One clear memory of a trauma
  • Stability on psychiatric medications for 1 month

Exclusion Criteria:

  • Active substance use/abuse (or in remission less than 3 mo)
  • Psychotic symptoms or diagnosis
  • Bipolar disorder diagnosis
  • Cognitive impairment
  • Involvement in a violent relationship
  • Self mutilation within past 6 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:16-Week Group Treatment
The 16-week treatment group will contain 3 blocks of treatment (exposure, cognitive, skills) with order randomized within the treatment. The first and last group session are considered inactive treatment sessions. The group treatment will be provided weekly.
Within the 16-week group treatment, the cognitive block will contain 5 sessions, the exposure block will contain 5 sessions, and the skills block will contain 4 sessions.
其他名称:
  • Cognitive treatment
  • Exposure treatment
  • Skills treatment
  • Group treatment
无干预:Wait List Control
The Wait List Control group will receive minimal attention, as they will meet bi-monthly for supportive sessions with the study psychologist. The study psychologist will not introduce any active treatment in the individual sessions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.
大体时间:Baseline, post-treatment, 3 months follow up, 6 months follow up.
Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).
Baseline, post-treatment, 3 months follow up, 6 months follow up.

次要结果测量

结果测量
措施说明
大体时间
Change in mental and physical functioning from baseline on the Health Related Quality of Life (SF36) to post-treatment, 3 months, and 6 months later.
大体时间:Baseline, post-treatment, 3-month follow up, 6-month follow up
Self-report questionnaire measures 8 life-functioning scales summarized by two content scales--Mental and Physical functioning.
Baseline, post-treatment, 3-month follow up, 6-month follow up
Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.
大体时间:Baseline, post-treatment, 3-month follow up, 6-month follow up
QOLI is a self-report questionnaire measuring overall quality of life across 16 domains.
Baseline, post-treatment, 3-month follow up, 6-month follow up
Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).
大体时间:Baseline, after each treatment block (every 5 weeks), post-treatment
The PCL is a self-report questionnaire measuring 17 PTSD symptoms.
Baseline, after each treatment block (every 5 weeks), post-treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Diane T Castillo, Ph.D.、New Mexico VA Healthcare System

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2014年2月14日

首先提交符合 QC 标准的

2014年2月20日

首次发布 (估计)

2014年2月24日

研究记录更新

最后更新发布 (估计)

2014年2月24日

上次提交的符合 QC 标准的更新

2014年2月20日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • W81XWH-08-2-0022
  • PT074309 (其他赠款/资助编号:Department of Defense)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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