- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00868517
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20422
- Washington DC VA Medical Center, Washington, DC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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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가짜 비교기: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Perceived Sleep Quality
기간: 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. |
t=2 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
기간: 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
기간: t=2 months
|
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
기간: 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
기간: t= 2 months
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t= 2 months
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Fragmented Sleep Patterns-Sleep Efficiency
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Michelle Kennedy Prisco, MSN BC-ANP, Washington DC VA Medical Center, Washington, DC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NRI 08-121
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