- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01625416
Trauma Survivors Outcomes and Support Study IV (TSOS IV)
Integrating Information Technology Advancements Into Early PTSD Interventions
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.
Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98104
- Harborview Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Score ≥3 on PTSD automated screening algorithm
- Score ≥35 on PTSD checklist (PCL-C)
Exclusion Criteria:
- Non-English speaking
- Under 14 years of age
- Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)
- Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
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 |
|---|---|
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실험적: Stepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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간섭 없음: Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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부상 후 6개월 동안 우울증 증상의 변화
기간: 연구자들은 기준선, 1개월, 3개월 및 6개월에 평가했습니다.
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조사관은 환자 건강 설문지(PHQ-9)를 1에서 27까지의 점수 범위로 연속 측정으로 사용했습니다.
높은 점수는 더 나쁜 결과를 나타냅니다.
하위 척도는 사용되지 않았습니다.
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연구자들은 기준선, 1개월, 3개월 및 6개월에 평가했습니다.
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Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
기간: The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure.
The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome.
No subscales were used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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Technology Use
기간: Baseline to 6 months
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The investigators used laptop tracking software to determine technology usage.
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Baseline to 6 months
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Feasibility/Acceptability of Intervention
기간: Baseline to 6 months
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The investigators used laptop tracking software to assess number of patients using laptops.
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Baseline to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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알코올 사용 문제
기간: 연구자들은 기준선, 1개월, 3개월 및 6개월에 평가했습니다.
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조사관은 알코올 사용 장애 식별 테스트(AUDIT)를 연속 측정으로 사용했습니다.
10개 항목 척도 점수의 범위는 0~40이며 값이 높을수록 결과가 좋지 않음을 나타냅니다.
하위 척도는 사용되지 않았습니다.
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연구자들은 기준선, 1개월, 3개월 및 6개월에 평가했습니다.
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Physical Functioning
기간: The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function.
The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
No other subscales will be used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Douglas Zatzick, M.D., University of Washington
간행물 및 유용한 링크
일반 간행물
- Zatzick D, O'Connor SS, Russo J, Wang J, Bush N, Love J, Peterson R, Ingraham L, Darnell D, Whiteside L, Van Eaton E. Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. J Trauma Stress. 2015 Oct;28(5):391-400. doi: 10.1002/jts.22041.
- Kelly CM, Van Eaton EG, Russo JE, Kelly VC, Jurkovich GJ, Darnell DA, Whiteside LK, Wang J, Parker LE, Payne TH, Mooney SD, Bush N, Zatzick DF. Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder. Psychiatry. 2017 Fall;80(3):279-285. doi: 10.1080/00332747.2016.1271162.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00001473
- 1R01AA016102-01 (미국 NIH 보조금/계약)
- 1K24MH086814-01 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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