- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01597856
Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (SBIRT-PTSD)
Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
연구 개요
상태
개입 / 치료
상세 설명
The Compensation examination that determines if a Veteran is entitled to any disability payments related to military service is a crucial gateway to accessing VA care for returning OEF/OIF Veterans. However, researchers and oversight agencies have noted that examiners typically do not have guidelines for evaluating comorbid conditions like substance abuse and for referring patients to treatment.
In the Evaluative Component of this study, OEF/OIF Veterans presenting for Compensation evaluations for PTSD will be approached to undergo a paid battery of confidential substance use, PTSD, service use and attitude assessments prior to their scheduled Compensation examinations. The batteries will be collected again twice, four and twelve weeks after the Compensation examinations. Long-term follow-up data will be extracted from VA databases including diagnoses, the results of the Veterans' Compensation evaluations, award determination, use of VA services and attendance at mental health and/or substance abuse treatment.
In the Clinical Trial Component of this study, one hundred sixty Veterans identified during the baseline evaluation as having a substance use disorder will be randomly assigned to a session of Screening, Brief Intervention and Referral to Treatment (SBIRT) or to No-Additional-Treatment. SBIRT is an approach to identifying and treating patients with substance abuse issues who are presenting for purposes other than substance abuse treatment. It involves Motivational Interviewing, which has been a consistently effective approach to facilitating engagement in substance abuse treatment in Veterans (Davis, Baer et al. 2003) and other populations. The study will examine factors associated with attendance at treatment including substance use, Veterans' beliefs about benefits, and compensation award. Group comparisons will be conducted on rates of treatment attendance, alcohol use, and PTSD symptoms.
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 West Haven Campus, West Haven, CT
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Tennessee
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Nashville, Tennessee, 미국, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Veteran of OEF or OIF,
- Not currently receiving VBA Compensation for PTSD,
- Able to participate psychologically and physically, able to give informed consent and complete, assessments, and participate in study procedures
- Between the ages of 18-65 years old.
Exclusion Criteria:
- Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move
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 |
---|---|
실험적: SBIRT
The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver. Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing. |
SBIRT Therapy overview-
|
간섭 없음: No additional treatment
Veterans assigned to the control condition will not receive any study-related therapy.
A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Treatment Attendance by Treatment Group Over Time
기간: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
|
Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time
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4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Substance Use by Treatment Group Over Time
기간: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
|
Mean days self-reported risky drug or alcohol use
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4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
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Mean PTSD Severity Score
기간: 12 weeks
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Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
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12 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Jankowski RL, Black AC, Lazar CM, Brummett BR, Rosen MI. Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims. PLoS One. 2019 Feb 6;14(2):e0210938. doi: 10.1371/journal.pone.0210938. eCollection 2019.
- Black AC, Meshberg-Cohen S, Perez-Ortiz AC, Thornhill TA, Rosen MI. Veterans' compensation claims beliefs predict timing of PTSD treatment use relative to compensation and pension exam. PLoS One. 2018 Dec 27;13(12):e0209488. doi: 10.1371/journal.pone.0209488. eCollection 2018.
- Meshberg-Cohen S, Kachadourian L, Black AC, Rosen MI. Relationship between substance use and attitudes towards seeking professional psychological help among veterans filing PTSD claims. Addict Behav. 2017 Nov;74:9-12. doi: 10.1016/j.addbeh.2017.05.024. Epub 2017 May 23.
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
- IIR 11-091
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
Attendance at Treatment에 대한 임상 시험
-
University of Helsinki완전한
-
Aclaris Therapeutics, Inc.완전한
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Institute of Child HealthGreat Ormond Street Hospital for Children NHS Foundation Trust완전한
-
Masonic Cancer Center, University of Minnesota완전한연조직 육종 | 수모세포종 | 망막모세포종 | 횡문근육종 | 간모세포종 | 원발성 악성 뇌 신생물 | CNS 종양 | 생식 세포 종양 | 유잉의 가족 종양 | 신장 종양 | 천막상부 원시신경외배엽종양(PNET) | 비정형 기형/횡문근 종양(AT/RT)미국
SBIRT에 대한 임상 시험
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Treatment Research InstitutePennsylvania Department of Health완전한
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University of Colorado, DenverNational Institute of Mental Health (NIMH); Washington State University; University of New...모병
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University of Central FloridaFlorida International University모집하지 않고 적극적으로
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Yale UniversityNational Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; National Center...완전한
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Yale UniversityNational Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; National Center...모집하지 않고 적극적으로
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Chestnut Health SystemsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한
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Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)완전한
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Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Environmental Health Sciences (NIEHS)완전한