Treatment of Insomnia in Military Veterans:Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 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).
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age is 18 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;
- •b. Frequency of insomnia complaint >3 times per week;
- •c. Duration of insomnia complaint >1 month
- •d. 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 for re-deployment over the following eight months
- •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 traumatic 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 during entire participation
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline and Post Intervention
PSQI Addendum for PTSD (PSQIA)
时间窗: Baseline and Post Intervention
Sleep quality defined by:PIRS 20 and the ISI
时间窗: Screening, Baseline, and Post Intervention
次要结局
- PTSD symptom severity as measured by the CAPS(Screening)
- Depression: BDI(Baseline and Post Intervention)
- Anxiety: BAI(Baseline and Post Intervention)
- Medical History: MHQ, MEDHIST_2WK, MOS(Screening, Baseline, and Post Intervention)
- Trauma History: THQ,CES,PCL-C,ICG(Screening, Baseline, and Post Intervention)
- Post Sleep Self Report: PSEQ-SV and POST(Screening)
- Sleepiness: EPWORTH, BASS(Screening, Baseline, and Post Intervention)
- Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey(Baseline and Post Intervention)
研究者
Anne Germain
Associate Professor
University of Pittsburgh