기술 강화 청소년 정신 건강(TEAM) (TEAM)
2025년 8월 13일 업데이트: University of Notre Dame
매우 취약한 청소년의 자해 및 약물 남용 위험을 줄이기 위해 바이오마커 및 신기술 활용
청소년 비자살적 자해(NSSI) 및 알코올 남용은 단독으로 특히 조합하여 성인기에 상당한 기능 장애(예: 관계 기능 장애, 우울증, 자살 경향)를 예고합니다.
NSSI 및 물질 사용에 대한 심리사회적 개입이 일부에게는 효과적이지만 비용이 많이 들고 고도로 훈련된 임상의가 필요합니다.
따라서 불우한 청소년과 시골에 사는 사람들은 종종 치료를 받을 수 없습니다.
따라서 저렴한 대체 치료법이 필요합니다.
우리는 우울증에 효과적인 치료법인 비침습적 경피적 미주 신경 자극(tVNS)이 취약한 청소년들 사이에서 NSSI 및 물질 남용의 위험을 줄이는 효능을 평가할 것입니다.
연구 개요
상세 설명
제안된 프로젝트의 가장 중요한 목표는 세 가지입니다. 목표 1: 취약한 청소년들 사이에서 NSSI 및 알코올 남용을 줄이는 데 있어 tVNS의 임상적 효능을 평가합니다. 우리는 25분 세션에서 제공되는 자가 관리 tVNS가 자가 보고 NSSI 및 알코올 사용을 줄이고, 청소년의 자가 보고 감정 조절을 개선하고, 감정 조절 및 취약성에 대한 교감 및 부교감 신경계 마커의 개선을 가져올 것이라는 가설을 세웁니다. NSSI 및 알코올 남용. 목표 2: 비슷한 기간의 전통적인 심리사회적 개입과 비교하여 치료 순응도를 평가합니다. 우리는 청소년이 비슷한 기간의 전통적인 심리사회적 개입에서 관찰된 것보다 더 큰 치료 순응도를 보여줄 것이며 tVNS를 허용 가능하고 눈에 거슬리지 않으며 대면 치료에 유리한 것으로 평가할 것이라고 가정합니다. 목표 3: tVNS에 대한 학대 효과를 평가합니다. 우리는 tVNS가 학대 이력이 있는 사람들에게 효과적일 것이라는 가설을 세웁니다.
지금까지 청소년들 사이에서는 거의 사용되지 않았지만 tVNS는 슬픈 자극에 대한 신경 및 정서적 반응을 변경하고 성인들 사이에서 최대 5년 후까지 자살 위험을 줄입니다. 현재 NIH가 지원하는 임상 시험에서 알코올 남용 치료제로 평가되고 있습니다. 이는 NSSI, 알코올 남용, 외상 후 스트레스 증상(PTSS) 및 기타 감정 조절 장애 장애를 치료할 가능성을 시사합니다. 위에서 설명한 바와 같이 NSSI 및 알코올 남용에 대한 행동, 감정 및 자율신경계 위험을 변경하는 데 있어 tVNS의 효능을 테스트하고, 청소년 사이에서 tVNS의 순응도 및 수용성을 평가하고, 학대 이력이 치료 반응을 완화하는지 판단합니다.
연구 유형
중재적
등록 (실제)
30
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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Indiana
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South Bend, Indiana, 미국, 46617
- University of Notre Dame
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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
13년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 술을 마신 적이 있다
- 지난 6개월 동안 NSSI의 3회 이상 또는 평생 5회 이상(이 5회 중 1회는 지난 1년 내에 있어야 함)
- 스마트폰 소유(iPhone 또는 Android)
제외 기준:
- 자폐성
- 정신 분열증
- 심장 박동기, 이식형 제세동기 또는 이식형 또는 금속 전자 장치가 있는 경우
- 임신 또는 모유 수유
- 발작이나 간질 병력이 있는 경우
- 악관절 장애
- 벨 마비
- 뇌신경 기능 장애 또는 안면 통증
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: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 치료군
참가자는 tVNS 장치를 받게 됩니다.
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참가자는 30일 동안 매일 25분 tVNS 세션에 참여하게 됩니다.
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실험적: 무치료군
참가자는 tVNS 장치를 받지 않습니다.
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참가자는 개입을 받지 않습니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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30일차에 비자살적 자해 및 알코올 남용 행동의 기준선에서 변경
기간: 30 일
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참가자는 매일 25분 tVNS 세션에 참여하게 됩니다.
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30 일
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중재 후 3개월째 치료 효과 유지
기간: 3 개월
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참가자는 개입 후 3개월 동안 이러한 치료 효과의 유지에 대해 평가됩니다.
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3 개월
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30일째 감정 조절의 기준선에서 변경
기간: 30 일
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참가자는 행복, 슬픔, 분노와 같은 다양한 느낌과 감정에 대해 보고하는 매일 2-3분 설문 조사를 완료합니다.
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30 일
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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기준선에서 30일까지 tVNS 개입 준수
기간: 30 일
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참가자의 자가 관리 매일 25분 tVNS 세션 준수 여부는 참가자의 tVNS 전화 앱에서 측정됩니다.
그들은 또한 tVNS의 수용 가능성, 눈에 띄는 정도 및 선호도에 대해 보고합니다.
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30 일
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Theodore P Beauchaine, PhD, University of Notre Dame
- 수석 연구원: Brooke A Ammerman, PhD, University of Notre Dame
- 수석 연구원: Kristin Valentino, PhD, University of Notre Dame
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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