Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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District of Columbia
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Washington、District of Columbia、美国、20422
- Washington DC VA Medical Center, Washington, DC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:True Group Auricular Acupuncture
Received true group auricular acupuncture twice weekly for a period of two months.
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Received true group auricular acupuncture
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假比较器:Sham Group Auricular Acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
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Received sham auricular acupuncture.
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其他:Wait-List Control Group
Served as wait list control.
Did not receive any acupuncture during the study period.
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Received conventional care only.
Eligible to receive true group auricular acupuncture once study period completed.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Perceived Sleep Quality
大体时间:t=2 months
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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. |
t=2 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
大体时间:t=2 months
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Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime).
Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.
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t=2 months
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Hypnotic Medication Use
大体时间:t=2 months
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Amount of sleep medication taken by study participants.
Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
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t=2 months
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Attrition Rates
大体时间:t=2 months
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Examined attendance rates in attending group sessions to examine attrition rates.
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t=2 months
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Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
大体时间:t= 2 months
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t= 2 months
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Fragmented Sleep Patterns-Sleep Efficiency
大体时间:t=2 months
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Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE).
Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.
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t=2 months
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合作者和调查者
调查人员
- 首席研究员:Michelle Kennedy Prisco, MSN BC-ANP、Washington DC VA Medical Center, Washington, DC
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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