The Effect of Acupuncture on PTSD-Related Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Perceived Sleep Quality
研究概览
简要总结
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.
详细描述
Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia. However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia. Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.
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
- Single
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
- •Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- •Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- •Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- •Diagnosis of insomnia made after PTSD diagnosis; and
- •If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
排除标准
- •Does not speak English;
- •Not competent to sign informed consent;
- •History of moderate or severe traumatic brain injury
- •Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- •Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- •History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above).
- •Received acupuncture during past 3 months.
- •On Coumadin, Heparin, or Lovenox
结局指标
主要结局
Perceived Sleep Quality
时间窗: t=2 months
Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings. ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of \> 8 is indicative of probable insomnia. The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality.
次要结局
- Hypnotic Medication Use(t=2 months)
- Attrition Rates(t=2 months)
- Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture(t= 2 months)
- Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps(t=2 months)
- Fragmented Sleep Patterns-Sleep Efficiency(t=2 months)