跳至主要内容
临床试验/NCT00840255
NCT00840255已完成不适用

Treatment of Insomnia in Military Veterans:Phase 2

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Pittsburgh Sleep Diary

研究概览

简要总结

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), finalizing a treatment manual.

详细描述

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 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. The specific aims of Phase II are: (1) To explore the effects of BBTI-MV on sleep and daytime symptoms of psychiatric distress. We anticipate that participants randomized to BBTI-MV will show a higher categorical response rate and remission for sleep symptoms than subjects randomized to IC. (2) To evaluate in a preliminary manner the durability of therapeutic gains and by conducting a naturalistic follow-up assessment six months post-treatment in responders. (3) To explore whether the nature of combat-related experiences, time since deployment and since, return to the US, deployment theater, medication use and change in dosage, mood and anxiety or disorders affect sleep treatment adherence and outcomes.

研究设计

研究类型
Interventional
分配方式
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

  • Age is 18 years old and older
  • Military returnees from OIF/OEF
  • 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
  • Frequency of insomnia complaint >3 times per week;
  • Duration of insomnia complaint >1 month
  • Associated with at least one daytime consequences
  • 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)
  • 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)

排除标准

  • Active duty personnel, or reservists/national guards scheduled to re-deploy if their departure date is < 2 months from the consent date
  • Untreated, current, and severe PTSD as determined on the SCID.
  • 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
  • Psychotic or bipolar disorder
  • Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
  • Unstable medical condition
  • Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
  • Seizure disorder or open skull brain injury.
  • 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.
  • Sleep apnea revealed during the screening sleep study.

结局指标

主要结局

Pittsburgh Sleep Diary

时间窗: Weekly

Pittsburgh Sleep Quality Index (PSQI)

时间窗: Baseline and Post Intervention

PSQI Addendum for PTSD (PSQIA)

时间窗: Baseline and Post

Sleep Quality defined by: PIRS-20 and ISI

时间窗: Screening,Baseline, and Post

次要结局

  • PTSD symptom severity as measured by the CAPS(Screening)
  • Depression: BDI(Baseline and Post)
  • Anxiety: BAI(Baseline and Post)
  • Medical History: MHQ, MEDHIST_2WK, MOS(Screening, Baseline, and Post)
  • Trauma History: THQ,CES,PCL-C,ICG(Screening, Baseline, and Post)
  • Post Sleep Self Report: PSEQ-SV and POST(Screening)
  • Sleepiness: EPWORTH, BASS(Screening, Baseline, and Post)
  • Mood and Behavior: BIS/BAS, SMITH, PANAS(Screening, Baseline, and Post)
  • Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey(Baseline and Post)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Germain

Associate Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验