- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01949389
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Connecticut
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West Haven, Connecticut, 미국, 06516
- VA Connecticut Healthcare System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
- Above Criteria occurring every week for greater than or equal to 3 months
- At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
- Able to provide valid consent
- Willing to participate in an internet-based cognitive behavioral therapy for insomnia
- English speaking
Exclusion Criteria:
- Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
- Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
- Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
- Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Internet-based Cognitive Behavioral Therapy for Insomnia
This is an internet-based Cognitive Behavioral treatment for insomnia.
It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log.
The intervention is self administered.
|
This is an internet-based Cognitive Behavioral treatment for insomnia.
It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log.
The intervention is self administered.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index (Total), Change From Baseline to Follow-up
기간: pre-intervention, intervention completion (expected average of 7 weeks)
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Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia. |
pre-intervention, intervention completion (expected average of 7 weeks)
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Completion of All 7 Modules of the Intervention
기간: on average 7 weeks
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Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program. |
on average 7 weeks
|
공동 작업자 및 조사자
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
- 01633
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