- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01655797
Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)
2012년 7월 30일 업데이트: Uppsala University
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach.
The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL).
Following an active treatment-control period, the control group were re-assigned to CBT.
The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group.
Primary outcome measure was a brief self-report screening form, Insomnia severity index.
연구 개요
연구 유형
중재적
등록 (실제)
66
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Uppsala, 스웨덴, 75105
- Uppsala University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Fulfilled research criteria for chronic insomnia
Exclusion Criteria:
- other untreated sleep disturbance
- pregnancy
- shift work
- concurrent medical or psychiatric condition that could be negatively affected by the treatment
- drug abuse
- severe depression
- dementia
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CBT
The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel.
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
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Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
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간섭 없음: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in the Insomnia severity index (ISI)
기간: After 9 weeks
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A brief self-report screening form
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After 9 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in sleep-onset latency (SOL)
기간: 9 weeks
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Time to fall asleep, measured with sleep diary
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9 weeks
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Change from baseline in wake time after sleep onset (WASO)
기간: After 9 weeks
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Time awake during the night, measured with sleep diary
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After 9 weeks
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Change from baseline in number of awakenings during the night (NWAK)
기간: After 9 weeks
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Measured with sleep diary
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After 9 weeks
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Change from baseline in Sleep efficiency (SE)
기간: After 9 weeks
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Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
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After 9 weeks
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Change from baseline in time in bed (TIB)
기간: After 9 weeks
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Measured with sleep diary
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After 9 weeks
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Change from baseline in total sleep time (TST)
기간: After 9 weeks
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Measured with sleep diary
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After 9 weeks
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Change from baseline in sleep quality (SQ)
기간: After 9 weeks
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Subjective sleep quality (likert scale)
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After 9 weeks
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Change from baseline in the fatigue severity scale (FSS)
기간: After 9 weeks
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Self-report questionnaire
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After 9 weeks
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Change from baseline in the MOS 36-item short-form health survey, SF-36
기간: After 9 weeks
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Questionnaire assessing physical and mental health
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After 9 weeks
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Change from baseline in the Hospital anxiety and depression scale, HADS
기간: After 9 weeks
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Self-report questionnaire measuring depression and anxiety
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After 9 weeks
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Change from baseline in the Epworth sleepiness scale, ESS
기간: After 9 weeks
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Self-report questionnaire assessing daytime sleepiness
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After 9 weeks
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Change form baseline in the Pittsburgh sleep quality index (PSQI)
기간: After 9 weeks
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Self-report form assessing sleep quality
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After 9 weeks
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Change from baseline in the Minimal insomnia severity scale, MISS
기간: After 9 weeks
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Ultra short screening questionnaire for insomnia
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After 9 weeks
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Change from baseline in the Insomnia acceptance questionnaire, IQA
기간: After 9 weeks
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A questionnaire intended to assess acceptance of insomnia
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After 9 weeks
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Change from baseline in Body mass index
기간: After 9 weeks
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After 9 weeks
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Change from baseline in sagittal abdominal diameter
기간: After 9 weeks
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Abdominal height (cm)
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After 9 weeks
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Change from baseline in waist-hip ratio
기간: After 9 weeks
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A ratio of the circumference of the waist to the hips
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After 9 weeks
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Change from baseline in blood pressure
기간: After 9 weeks
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After 9 weeks
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Change from baseline in heart rate
기간: After 9 weeks
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After 9 weeks
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Change from baseline in ALAT
기간: After 9 weeks
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Liver function
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After 9 weeks
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Change from baseline in HbA 1c
기간: After 9 weeks
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Glycated hemoglobin
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After 9 weeks
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Change from baseline in blood glucose
기간: After 9 weeks
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After 9 weeks
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Change from baseline in triglycerides
기간: After 9 weeks
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A type of fat found in the blood
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After 9 weeks
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Change from baseline in cholesterol (LDL/HDL)
기간: After 9 weeks
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After 9 weeks
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Change from baseline in sleep-onset latency (SOL)
기간: After 18 months
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Time to fall asleep, measured with sleep diary
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After 18 months
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Change from baseline in wake time after sleep onset (WASO)
기간: After 18 months
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Time awake during the night, measured with sleep diary
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After 18 months
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Change from baseline in number of awakenings during the night (NWAK)
기간: After 18 months
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Measured with sleep diary
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After 18 months
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Change from baseline in Sleep efficiency (SE)
기간: After 18 months
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Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
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After 18 months
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Change from baseline in time in bed (TIB)
기간: After 18 months
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Measured with sleep diary
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After 18 months
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Change from baseline in total sleep time (TST)
기간: After 18 months
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Measured with sleep diary
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After 18 months
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Change from baseline in sleep quality (SQ)
기간: After 18 months
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Subjective sleep quality (likert scale)
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After 18 months
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Change from baseline in the fatigue severity scale (FSS)
기간: After 18 months
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Self-report questionnaire
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After 18 months
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Change from baseline in the MOS 36-item short-form health survey, SF-36
기간: After 18 months
|
Questionnaire assessing physical and mental health
|
After 18 months
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Change from baseline in the Hospital anxiety and depression scale, HADS
기간: After 18 months
|
Self-report questionnaire measuring depression and anxiety
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After 18 months
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Change from baseline in the Epworth sleepiness scale, ESS
기간: After 18 moths
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Self-report questionnaire assessing daytime sleepiness
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After 18 moths
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Change form baseline in the Pittsburgh sleep quality index (PSQI)
기간: After 18 months
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Self-report form assessing sleep quality
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After 18 months
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Change from baseline in the Minimal insomnia severity scale, MISS
기간: After 18 months
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Ultra short screening questionnaire for insomnia
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After 18 months
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Change from baseline in the Insomnia acceptance questionnaire, IQA
기간: After 18 months
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A questionnaire intended to assess acceptance of insomnia
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After 18 months
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Change from baseline in Body mass index
기간: After 18 months
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After 18 months
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Change from baseline in sagittal abdominal diameter
기간: After 18 months
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Abdominal height (cm)
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After 18 months
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Change from baseline in waist-hip ratio
기간: After 18 months
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A ratio of the circumference of the waist to the hips
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After 18 months
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Change from baseline in blood pressure
기간: After 18 months
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After 18 months
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Change from baseline in heart rate
기간: After 18 months
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After 18 months
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Change from baseline in ALAT
기간: After 18 months
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Liver function
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After 18 months
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Change from baseline in HbA 1c
기간: After 18 months
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Glycated hemoglobin
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After 18 months
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Change from baseline in blood glucose
기간: After 18 months
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After 18 months
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Change from baseline in triglycerides
기간: After 18 months
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A type of fat found in the blood
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After 18 months
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Change from baseline in cholesterol (LDL/HDL)
기간: After 18 months
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After 18 months
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Change from baseline in the Insomnia severity index (ISI)
기간: After 18 months
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A brief self-report screening form
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After 18 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jan-Erik Broman, PhD, Uppsala University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.
- Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 5월 1일
기본 완료 (실제)
2011년 9월 1일
연구 완료 (실제)
2011년 9월 1일
연구 등록 날짜
최초 제출
2012년 7월 4일
QC 기준을 충족하는 최초 제출
2012년 7월 30일
처음 게시됨 (추정)
2012년 8월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 8월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 7월 30일
마지막으로 확인됨
2012년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Cognitive behavior therapy for insomnia에 대한 임상 시험
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