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Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 1 (BBTIMV1)

2012年6月15日 更新者:Anne Germain、University of Pittsburgh

Treatment of Insomnia in Military Veterans:Phase 1

The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).

研究概览

详细说明

Insomnia is one of the most common reasons for referral to mental health services in active duty personnel. Chronic insomnia often persists post-deployment, contributes to poor mental and physical health outcomes, and requires targeted interventions. Effective behavioral treatments of insomnia have not been adapted and tested for the treatment of chronic insomnia comorbid to combat-related mental disorders and stress reactions. In addition, effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal of this R34 Exploratory Clinical Research Grant is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions. We call this intervention the Brief Behavioral Treatment of Insomnia for Military Veterans (BBTI-MV). The proposed study includes two phases. Phase I aims at iteratively adapting and refining a treatment manual for insomnia in OIF/OEF military returnees. Outcomes of interest include self-report, diary, and actigraphic sleep measures, as well as measures of PTSD, anxiety, and depression, and perceived physical health.

研究类型

介入性

注册 (实际的)

12

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • Western Psychiatric Institute and Clinic

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age is 18 and older.
  2. Military returnees from OIF/OEF
  3. Meet diagnostic criteria for chronic insomnia as defined by:

    • a. Complaint of sleep latency >30 minutes, or wake time after sleep onset >30 minutes, or Sleep Efficiency <85%, or a complaint of non-restorative sleep;
    • b. Frequency of insomnia complaint >3 times per week;
    • c. Duration of insomnia complaint >1 month
    • d. Associated with at least one daytime consequences
  4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
  5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)

Exclusion Criteria:

  1. Active duty personnel, or reservists/national guards scheduled for re-deployment over the following eight months
  2. Untreated, current, and severe PTSD as determined on the SCID.
  3. Untreated, current, and severe Major Depressive Disorder as determined by the Structured Clinical Interview for DSM-IV and a score > 30 on the Beck Depression Inventory
  4. Psychotic or bipolar disorder
  5. Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
  6. Unstable medical condition
  7. Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
  8. Seizure disorder or traumatic brain injury.
  9. Current sleep disorders such as nightmare disorder, restless legs syndrome, or suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements.
  10. Sleep apnea revealed during the screening sleep study.
  11. Pregnancy.

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Brief Behavioral Treatment for Insomnia
Effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.
其他名称:
  • BBTI

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Pittsburgh Sleep Diary
大体时间:Weekly during entire participation
Weekly during entire participation
Pittsburgh Sleep Quality Index (PSQI)
大体时间:Baseline and Post Intervention
Baseline and Post Intervention
PSQI Addendum for PTSD (PSQIA)
大体时间:Baseline and Post Intervention
Baseline and Post Intervention
Sleep quality defined by:PIRS 20 and the ISI
大体时间:Screening, Baseline, and Post Intervention
Screening, Baseline, and Post Intervention

次要结果测量

结果测量
大体时间
PTSD symptom severity as measured by the CAPS
大体时间:Screening
Screening
Depression: BDI
大体时间:Baseline and Post Intervention
Baseline and Post Intervention
Anxiety: BAI
大体时间:Baseline and Post Intervention
Baseline and Post Intervention
Medical History: MHQ, MEDHIST_2WK, MOS
大体时间:Screening, Baseline, and Post Intervention
Screening, Baseline, and Post Intervention
Trauma History: THQ,CES,PCL-C,ICG
大体时间:Screening, Baseline, and Post Intervention
Screening, Baseline, and Post Intervention
Post Sleep Self Report: PSEQ-SV and POST
大体时间:Screening
Screening
Sleepiness: EPWORTH, BASS
大体时间:Screening, Baseline, and Post Intervention
Screening, Baseline, and Post Intervention
Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
大体时间:Baseline and Post Intervention
Baseline and Post Intervention

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:Anne Germain, PhD.、University of Pittsburgh, Department of Psychiatry

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

2008年6月1日

初级完成 (实际的)

2009年4月1日

研究完成 (实际的)

2009年4月1日

研究注册日期

首次提交

2008年5月14日

首先提交符合 QC 标准的

2008年5月15日

首次发布 (估计)

2008年5月16日

研究记录更新

最后更新发布 (估计)

2012年6月18日

上次提交的符合 QC 标准的更新

2012年6月15日

最后验证

2012年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • PRO07110063
  • NIMH: 1 R34 MH080696

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.

Brief Behavioral Treatment for Insomnia的临床试验

3
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