- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02420561
우울증 환자의 물질 사용을 줄이기 위한 동기 부여 인터뷰
2015년 6월 8일 업데이트: University of California, San Francisco
이 연구의 목표는 우울증을 동반한 위험한 음주나 약물 사용을 보고한 우울증 치료를 받고 있는 300명의 성인 샘플을 대상으로 알코올 및 약물 사용과 우울증 증상을 줄이고, 기능적 상태를 개선하고, 적절한 의료 서비스 이용을 촉진하기 위한 개입의 효과를 평가하는 것입니다. .
연구 개요
상세 설명
이 연구는 우울증을 악화시킬 수 있는 알코올 또는 약물 사용으로 서비스를 받기 위해 제시하는 정신과 환자를 식별하고 치료하는 방법에 관한 중요한 질문을 다룹니다.
조사관은 우울증 환자의 약물 및 알코올 사용을 줄이고 필요에 따라 카이저 약물 의존 회복 프로그램(CDRP) 참여를 강화하기 위한 BMI(간단한 동기 부여 개입) 연구를 제안합니다.
하위 진단 수준에서도 약물이나 알코올을 사용하는 우울증 환자는 물질 문제가 확대될 위험이 높습니다.
BMI는 약물 및 알코올 사용을 줄이고 결과를 개선할 수 있는 혁신적이고 증거 기반 접근 방식입니다.
그러나 우울증 환자들 사이에서는 테스트되지 않았습니다.
이 연구 샘플에는 Kaiser Permanente Northern California Hayward/Fremont Psychiatry에서 우울증 치료를 받는 300명의 외래 환자가 포함될 것입니다.
포함 기준은 약물 사용(모든 불법 약물 사용 및 처방약의 비처방 사용) 및 위험한 음주(즉, 여성의 경우 하루에 ≥ 3잔, 남성의 경우 하루에 ≥ 4잔)를 기반으로 하며, 중등도에서 중증 섭취시 우울증 증상.
300명의 환자가 무작위로 선택되어 섭취(개입) 6주 이내에 대면 BMI 세션 1회와 전화 BMI 세션 2회 또는 약물 및 알코올 사용 위험에 대한 브로셔(대조)를 받게 됩니다.
조사관은 3개월, 6개월 및 12개월 전화 후속 인터뷰에서 개입이 약물 사용 빈도와 위험한 음주를 줄이는 데 효과적일 것으로 예상합니다. 기분 및 기능적 결과 개선; 우울증 치료 유지 증가(Healthcare Effectiveness Data and Information Set(HEDIS) 표준에 기반한 정신과 방문 횟수); 필요한 경우 약물 의존 프로그램 치료의 환자 시작을 촉진하고 비용 효율적일 것입니다.
환자 치료 개선을 위해 정신의학에서 알코올 및 약물 개입을 통합하는 방법과 필요할 때 환자가 전문 CDRP 서비스에 액세스하도록 돕는 최선의 방법에 대한 중요한 정보를 얻을 수 있습니다.
연구 유형
중재적
등록 (실제)
307
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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California
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Union City, California, 미국, 94545
- Kaiser Permanente Medical Center Southern Alameda County
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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
포함 기준:
- 위험한 음주(즉, 여성의 경우 하루에 ≥ 3잔, 남성의 경우 하루에 ≥ 4잔)
- 약물 사용(이전 30일 동안의 모든 불법 약물 사용 및 비처방 처방약 사용 포함)
- 환자 건강 설문지(PHQ-9)에서 5점 이상을 기준으로 중등도 이상의 우울증 증상
제외 기준:
- 현재 조증 또는 정신병
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 동기 부여 인터뷰
동기 부여 인터뷰(MI) 중재는 45분간의 대면 MI 세션 1회와 15분간의 전화 "부스터" 세션 2회로 구성되었습니다.
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활성 비교기: 제어
참가자들은 알코올 및 약물 사용 위험에 대한 브로셔를 받았습니다.
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참가자들은 알코올 및 약물 사용 위험에 대한 브로셔를 받았습니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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최근 30일 동안의 유해음주(위험음주 일수 자가보고)
기간: 6 개월
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지난 30일 동안 자가 보고한 위험한 음주 일수(여성의 경우 하루 3잔 이상/남성의 경우 하루 4잔 이상).
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6 개월
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지난 30일 동안의 약물 사용(자기 보고한 약물 사용 일수)
기간: 6 개월
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이전 30일 동안 자가 보고한 약물 사용 일수(불법 약물 사용 또는 처방약 오용).
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6 개월
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최근 30일 동안의 유해음주(위험음주 일수 자가보고)
기간: 12 개월
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지난 30일 동안 자가 보고한 위험한 음주 일수(여성의 경우 하루 3잔 이상/남성의 경우 하루 4잔 이상).
장기 개입 영향을 측정하기 위해 6개월 사용과 12개월 사용 사이의 변화를 조사합니다.
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12 개월
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지난 30일 동안의 약물 사용(자기 보고한 약물 사용 일수)
기간: 12 개월
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이전 30일 동안 자가 보고한 약물 사용 일수(불법 약물 사용 또는 처방약 오용).
장기 개입 영향을 측정하기 위해 6개월에서 12개월 사이의 사용 변화를 조사합니다.
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12 개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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우울증 증상(환자 건강 설문지(PHQ-9) 점수)
기간: 12 개월
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후속 전화 인터뷰에서 측정. PHQ-9는 지난 2주 동안 9가지 유형의 문제 빈도를 평가합니다. 응답 범위는 0(전혀 아님)에서 3(거의 매일)까지입니다.
9개 중 4개 이상이 0보다 크면 항목 점수의 합계가 우울증의 심각도를 나타내는 데 사용됩니다. 1-4 최소; 5-9 약함; 10-14 보통; 15-19 중등도; 20-27 심함.
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12 개월
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적절한 정신 건강 치료(Kaiser Permanente 외래 환자 정신과에서 12주 연속 치료를 받는 참가자 수)
기간: 3 개월
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Kaiser Permanente 외래 정신과에서 12주 연속 치료를 받은 참가자 수
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3 개월
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Derek D Satre, PhD, University of California, San Francisco
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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