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Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (SBIRT-PTSD)

2020年1月10日 更新者:VA Office of Research and Development

Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims

Veterans can apply for compensation and pension (C & P) benefits for a disability related to military service. The application exam for these benefits provides an opportunity for Veterans returning from service to access VA care. The investigators will recruit Veterans applying for C & P to participate in this study. All enrolled participants will complete questionnaires around the time of their C & P exam related to substance abuse, PTSD, service use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment over time, and examine whether C & P award, substance use, and beliefs about benefits are related to treatment attendance. Some enrolled participants will be assigned to one of two study groups: a treatment group and a no-additional-treatment group. People assigned to these groups will complete the same substance abuse, PTSD, service use, and attitudes questionnaires two additional times during the study. Participants assigned to the treatment group will receive information about the relationship between substance use and PTSD and will be referred to relevant treatment. The investigators will test whether Veterans who receive no-additional-treatment have different symptoms over time and attend less treatment sessions (mental health or substance abuse) than people assigned to treatment.

研究概览

详细说明

The Compensation examination that determines if a Veteran is entitled to any disability payments related to military service is a crucial gateway to accessing VA care for returning OEF/OIF Veterans. However, researchers and oversight agencies have noted that examiners typically do not have guidelines for evaluating comorbid conditions like substance abuse and for referring patients to treatment.

In the Evaluative Component of this study, OEF/OIF Veterans presenting for Compensation evaluations for PTSD will be approached to undergo a paid battery of confidential substance use, PTSD, service use and attitude assessments prior to their scheduled Compensation examinations. The batteries will be collected again twice, four and twelve weeks after the Compensation examinations. Long-term follow-up data will be extracted from VA databases including diagnoses, the results of the Veterans' Compensation evaluations, award determination, use of VA services and attendance at mental health and/or substance abuse treatment.

In the Clinical Trial Component of this study, one hundred sixty Veterans identified during the baseline evaluation as having a substance use disorder will be randomly assigned to a session of Screening, Brief Intervention and Referral to Treatment (SBIRT) or to No-Additional-Treatment. SBIRT is an approach to identifying and treating patients with substance abuse issues who are presenting for purposes other than substance abuse treatment. It involves Motivational Interviewing, which has been a consistently effective approach to facilitating engagement in substance abuse treatment in Veterans (Davis, Baer et al. 2003) and other populations. The study will examine factors associated with attendance at treatment including substance use, Veterans' beliefs about benefits, and compensation award. Group comparisons will be conducted on rates of treatment attendance, alcohol use, and PTSD symptoms.

研究类型

介入性

注册 (实际的)

346

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

    • Connecticut
      • West Haven、Connecticut、美国、06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Tennessee
      • Nashville、Tennessee、美国、37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

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

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Veteran of OEF or OIF,
  • Not currently receiving VBA Compensation for PTSD,
  • Able to participate psychologically and physically, able to give informed consent and complete, assessments, and participate in study procedures
  • Between the ages of 18-65 years old.

Exclusion Criteria:

  • Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move

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:SBIRT

The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.

Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.

SBIRT Therapy overview-

  1. Therapist explains purpose of the therapy.
  2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
  3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
  4. Discuss treatment needs, administer screening, provide feedback.
无干预:No additional treatment
Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.

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
Treatment Attendance by Treatment Group Over Time
大体时间:4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks

次要结果测量

结果测量
措施说明
大体时间
Substance Use by Treatment Group Over Time
大体时间:4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean days self-reported risky drug or alcohol use
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean PTSD Severity Score
大体时间:12 weeks
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
12 weeks

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。

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。

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 (实际的)

2013年3月18日

初级完成 (实际的)

2017年9月30日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2012年5月10日

首先提交符合 QC 标准的

2012年5月11日

首次发布 (估计)

2012年5月14日

研究记录更新

最后更新发布 (实际的)

2020年1月27日

上次提交的符合 QC 标准的更新

2020年1月10日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • IIR 11-091

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

Attendance at Treatment的临床试验

SBIRT的临床试验

3
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