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临床试验/NCT03933059
NCT03933059已完成不适用

Suicide and Trauma Reduction Initiative Among VEterans

University of Utah2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale

研究概览

简要总结

The present study is a pragmatic clinical trial that will examine the effectiveness of Cognitive Processing Therapy (CPT) in reducing PTSD symptom severity, depression symptoms, and suicidal thoughts among military personnel and veterans with PTSD when delivered in three different formats: (1)12 sessions delivered once per week in an office/clinic setting; (2) 12 sessions delivered once per day in an office/clinic setting; and (3) 12 sessions delivered once per day in a recreational setting.

详细描述

Cognitive behavioral treatments tend to be the most highly efficacious treatments for posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was among the most effective treatments for PTSD (Watts et al., 2013). Despite its efficacy, many military personnel and veterans with PTSD will not receive CPT (or other recommended treatments) for a variety of reasons. It is possible that adapting CPT from its traditional weekly or biweekly format might both enhance the provision of CPT and reduce barriers to treatment. Specifically, treatment that is compressed into a relatively shorter window may be easier for service members and veterans to complete.

In light of these possibilities, the National Center for Veterans Studies (NCVS) at The University of Utah created the R&R program, an intensive, two-week treatment program for service members and veterans diagnosed with PTSD in partnership with the National Ability Center (NAC), a nonprofit recreational and adaptive sports center located in Park City, Utah. The R&R Program provides CPT in a format designed to circumvent logistical barriers to care and to maximize treatment completion. Preliminary results from 20 service members or veterans who have completed the program show that approximately 70% no longer met criteria for PTSD after completing the program, and suicide ideation decreased significantly (Bryan et al., 2018). Treatment gains during R&R were superior to those found in CPT randomized trials.

The present study seeks to build and broaden current research on CPT. First, it will directly compare the effectiveness of traditional 12-session weekly outpatient CPT against intensive, daily delivery of CPT over 12 days. Second, it will test whether the use of recreational activities improves intensive care by comparing intensive treatment at the NAC with recreational activities against intensive treatment in Salt Lake City without recreational activities. Finally, it will provide important data on the long-term effects of treatment, by assessing PTSD, depression, and suicidal thoughts and behaviors at posttreatment, and 6, 12, and 24 months posttreatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • 18 years of age or older;
  • Current or prior service in the U.S. military;
  • Currently meet criteria for a diagnosis of posttraumatic stress disorder (as determined by the CAPS-5);
  • Be able to complete the informed consent process.

排除标准

  • Current substance dependence disorder;
  • Severe suicide ideation during the past two weeks (as determined by the BSSI and clinical interview) warranting hospitalization;
  • Suicide attempt during the previous three months;
  • Impaired mental status that precludes ability to provide informed consent (e.g., intoxication, psychosis, mania).

结局指标

主要结局

Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale

时间窗: Past week symptoms, assessed the last day of treatment for those completing the two week treatment retreats

Interviewer administered measure to determine the severity of PTSD. Items are summed to create a total score (Range: 0-80) where higher scores indicate greater symptom severity.

次要结局

  • Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation(Past week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment)
  • Change in depression symptom severity since baseline measured by the Patient Health Questionnaire(Past two week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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