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Innovative Service Delivery for Secondary Prevention of PTSD

2015年9月11日 更新者:Charleston Research Institute

Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

The purpose of this study is to determine whether therapy for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder (PTSD) symptoms can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate.

研究概览

详细说明

OIF and OEF service men and women exposed to high levels of violence are at risk for developing mental health disorders including Post-traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Even those with less severe symptoms who fail to meet diagnostic criteria for a mental health disorder may struggle to return to pre-deployment functioning. Studies suggest that a significant percentage of veterans may suffer from "subthreshold" PTSD; although their symptom presentation is less severe, these veterans experience emotional distress and reduced quality of life.

Given that Veterans Affairs (VA) mental-health service providers are faced with the important and challenging task of alleviating the emotional suffering of our service men and women while staying within budget confines, we need effective, practical, evidence-based treatments that can be delivered in an expedient and cost-effective manner. Thus, the current project has two primary objectives: 1) to develop, implement, and evaluate a treatment program (Behavioral Activation and Therapeutic Exposure, BATE) for OIF and OEF veterans with PTSD symptoms, and 2) to determine whether or not this program delivered via telepsychology will be as effective as in-person treatment. Secondary objectives include determining: 1) which treatment modality is more effective in terms of process variables (e.g., treatment satisfaction, session attendance), 2) which treatment modality is more cost-effective, and 3) whether treatment effects differ across race and gender. Study participants will be randomized to two treatment conditions, BATE delivered via telepsychology (BATE-T) and BATE delivered in-person (BATE-IP).

The current treatment protocol is based on two, research-supported therapeutic rationales, Behavioral Activation (BA) and Therapeutic Exposure (TE). Briefly, the treatment aims to increase the participant's engagement in healthy activities (i.e., activities that are naturally reinforcing and promote the participant's life values) and exposure activities (i.e., activities that target specific PTSD symptoms such as avoidance and hyperarousal). Treatment will be implemented in eight, one and half hour sessions. Although research supports the effectiveness of behavior- and exposure-based treatments for trauma-related mental health problems, a potential risk for any counseling program that targets avoidance symptoms is a temporary increase in emotional distress. Therapists will inform participants that this is a normal "side effect" of treatment. However, over the course of treatment should a participant's emotional distress rise to a level above what can be handled via outpatient counseling, the participant will be removed from the study and appropriate referrals will be made.

The anticipated duration of this study is four years. Based on results of the study, we will finalize the treatment manual. In terms of clinical applicability, we plan to present study findings at conferences and disseminate the treatment manual to VA mental health service providers in approximately four to five years. Study findings will address important gaps in the PTSD literature, yielding several contributions to the field. First, to the extent that BATE effectively reduces symptom severity, this investigational treatment may benefit individual OIF/OEF service men and women by alleviating emotional suffering and improving quality of life. Second, to the extent that BATE prevents the development of full-blown PTSD in subclinical military personnel, this investigational treatment may reduce attrition from the military due to untreated mental health problems. Third, only a small percentage of those who might benefit from counseling actually seek services due to barriers associated with traditional service delivery practices such as geographic distance from the VA hospital and stigma of psychological treatment. Thus, as telemedicine has been shown to circumvent these barriers to care, the current project has the potential to reach an otherwise underserved population: subclinical OIF and OEF service men and women who may be reluctant to seek care. Fourth, to the extent that BATE-T produces results comparable to BATE-IP, this study may potentially identify a cost-effective alternative to in-person treatment thereby reducing post-service treatment costs to VA's.

研究类型

介入性

注册 (实际的)

280

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

    • South Carolina
      • Charleston、South Carolina、美国、29403
        • Medical University of South Carolina
      • Charleston、South Carolina、美国、29403
        • Ralph H. Johnson VAMC

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

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants will be OIF/OEF military personnel,
  • age 21 and above, and
  • with symptoms of posttraumatic stress disorder (PTSD) assigned on the basis of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M).

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting criteria for substance dependence will be excluded from participation.

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:BATE-T
Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
有源比较器:BATE-IP
Behavioral Activation Therapeutic Exposure done in the therapist's office
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

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
The major objective of this study is to determine if Behavioral Activation with Therapeutic Exposure (BATE) delivered via Telemedicine is as effective as BATE In Person.
大体时间:1 year
This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.
1 year

次要结果测量

结果测量
措施说明
大体时间
贝克抑郁量表-II (BDI-II)
大体时间:基线
基线
贝克抑郁量表-II (BDI-II)
大体时间:3个月
3个月
临床医生管理的 PTSD 量表 (CAPS)
大体时间:8周
8周
Clinician Administered PTSD Scale (CAPS)
大体时间:Baseline
Baseline
Clinician Administered PTSD Scale (CAPS)
大体时间:3 months
3 months
Clinician Administered PTSD Scale (CAPS)
大体时间:1 year
1 year
The Deployment Risk and Resiliency Inventory (DRRI)
大体时间:Baseline
Baseline
PTSD Checklist-Military (PCL-M)
大体时间:Baseline
Baseline
PTSD Checklist-Military (PCL-M)
大体时间:4 weeks
4 weeks
PTSD Checklist-Military (PCL-M)
大体时间:8 weeks
8 weeks
PTSD Checklist-Military (PCL-M)
大体时间:3 months
3 months
PTSD Checklist-Military (PCL-M)
大体时间:1 year
1 year
Beck Depression Inventory-II (BDI-II)
大体时间:4 weeks
4 weeks
Beck Depression Inventory-II (BDI-II)
大体时间:8 weeks
8 weeks
Beck Depression Inventory-II (BDI-II)
大体时间:1 year
1 year
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:Baseline
Baseline
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:4 weeks
4 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:8 weeks
8 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:3 months
3 months
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:1 year
1 year
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
大体时间:8 weeks
8 weeks
Service Delivery Perceptions Questionnaire
大体时间:8 weeks
8 weeks
Prior Experience with Computer and Audiovisual Technology
大体时间:Baseline
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
Baseline

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:Ronald Acierno, PhD、VA Office of Research and Development

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3月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2010年4月12日

首先提交符合 QC 标准的

2010年8月5日

首次发布 (估计)

2010年8月9日

研究记录更新

最后更新发布 (估计)

2015年9月14日

上次提交的符合 QC 标准的更新

2015年9月11日

最后验证

2015年9月1日

更多信息

与本研究相关的术语

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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