Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial (WEST)
2026년 8월 20일 업데이트: Rebecca Schacht, Potomac Health Foundations
Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST)
The purpose of the current research study is to evaluate the efficacy of the refined Written Exposure in Substance Treatment (WEST) for PTSD among residential SUD patients through a randomized controlled trial.
All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research.
Participants will be randomly assigned to WEST + treatment as usual (TAU) or TAU only.
The primary outcome is change in PTSD symptoms from pre-intervention to post-intervention.
The secondary outcome will be change in SUD outcomes (e.g., treatment completion, reduced opioid and other drug use) and change in non-PTSD mental health outcomes (e.g., depression) from pre-intervention to post-intervention.
연구 개요
연구 유형
중재적
등록 (추정된)
400
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kevin Wenzel, PhD
- 전화번호: 410-233-1400
- 이메일: kwenzel@marylandtreatment.org
연구 연락처 백업
- 이름: Rebecca Schacht, PhD
- 전화번호: 410-455-5626
- 이메일: rschacht@umbc.edu
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21229
- Maryland Treatment Centers
-
연락하다:
- Kevin Wenzel, PhD
- 전화번호: 410-233-1400
- 이메일: kwenzel@marylandtreatment.org
-
연락하다:
- Marc Fishman, MD
- 전화번호: 410-233-1400
- 이메일: mfishman@marylandtreatment.org
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- be enrolled in residential SUD treatment at MTC
- meet criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5
- be 18 years of age or older
- have sufficient memory of the index trauma to write about it
- be sufficiently able to speak, read, and write in the English language to complete WEST therapy and study assessments.
Exclusion Criteria:
- Inability to give informed consent for any reason (e.g., cognitive impairment)
- Presence of acute psychosis that would interfere with study participation
- Suicide attempt within the past 3 months
- History of psychiatric hospitalization within the past month
- Presence of any other psychiatric instability or suicidality that would interfere with study participation
- Planning to leave residential treatment before WEST could realistically be completed as determined by the investigator
- Lack of access to a mobile phone after treatment discharge
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tau + 적응 된 필기 노출 요법 (습식)
이 상태의 참가자는 Tau에 포함 된 모든 것을 치료사가 전달한 습식 세션에 5 개의 개별 세션을받습니다.
WET는 전문가 피드백에 따라 주거용 SUD 환경에서 배달을 위해 조정되었습니다.
세션은 평균 60 분 미만이며 주로 치료사가 안내하는 외상 경험에 대한 글쓰기를 포함합니다.
|
서면 노출 요법은 PTSD에 대한 간단하고 입증 된 기반 중재입니다.
WET는 일반적으로 치료사가 작문 연습을 통해 환자를 안내하는 5 개의 세션에서 개별적으로 전달됩니다.
노출 세션에 걸쳐 참가자들은 습관화를 경험하여 치료가 끝날 때 증상이 감소합니다.
WET는 PTSD에 대한 일반적인 외래 환자 심리 치료에 대한 확립 된 증거 기반을 가지고 있지만 주거용 SUD 치료 환경에서는 적응하거나 테스트되지 않았습니다.
또한, 연구자들은 이해 관계자와 전문가 피드백을 기반 으로이 환경에 대해 습식을 조정했습니다.
|
|
활성 비교기: TAU
Treatment as Usual will include a variety of standard care services offered in short term residential treatment.
|
평소와 같이 치료에는 단기 주거 치료에서 제공되는 다양한 표준 치료 서비스가 포함됩니다.
예를 들어, TAU를받는 참가자는 약물 사용 장애 및 그 결과에 중점을 둔 개별 사례 관리/일반 상담 세션, 그룹 기반 심리 교육 세션, 그룹 기반 상담 세션 (예 : 재발 예방 계획), 의료 서비스 제공자 및 약학 요법 (예 : 철회, 재발 예방 또는 코링 조건)에 중점을 둔 개별 사례 관리/일반 상담 세션에 참여할 것입니다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PTSD symptom reduction
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
PTSD symptom reduction pre/post intervention by treatment arm as measured by he PTSD Checklist for DSM-5 (PCL-5) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS).
The PCL-5 is a 20-item self-report questionnaire that yields a total symptom scores ranging from 0-80 with higher scores indicating greater symptomology.
The CAPS is a 30-item structured interview that yields a diagnosis of PTSD, a total PTSD symptom severity score, and a severity score for each symptom cluster.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Days of Substance Use
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Timeline Follow-back (TLFB) will assess opioid and other substance use in the 30 days prior to residential treatment admission and at all follow-ups.
Participants will be shown a reference sheet that describes standard drinks (see attached) to help them more easily recall how many standard drinks they have consumed in the past month.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Substance Use Exposure
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Kreek-McHugh-Schuluger-Kellogg scale (KMSK) will assess participants' lifetime and past 30-day exposure to specific substances.
The KMSK items assessing past 30-day usage will be administered during all follow up appointments.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Anxiety Symptoms
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Depressive Symptoms
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Recovery Capital
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Brief Assessment of Recovery Capital (BARC-10) will assess participant-reported areas of recovery capital. Multidimensional Inventory of Recovery Capital (MIRC): designed to assess the resources a person uses to resolve alcohol or drug problems. |
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Treatment Outcomes
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Treatment Utilization Self-Report Form: an investigator-created form will collect data on ongoing engagement in SUD treatment, mental health, and hospital services. Medication Continuity assessment (see participant information document): will track adherence with medications prescribed during treatment, including addiction-related and other psychotropic medications. |
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Moral Injury
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Emotion Regulation
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Self Efficacy
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Discharge related outcomes
기간: Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)
|
Discharge Chart Abstraction (see attached): An investigator-created form will gather information on inpatient treatment completion status, successful initiation on relapse prevention medications for opioid use disorder and alcohol use disorder, and continuing care referrals made by the inpatient treatment team.
|
Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)
|
|
Barriers to Treatment
기간: This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.
|
Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.
|
This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.
|
|
Adverse Events
기간: 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Adverse Events Reporting Form (see participant information document): An investigator- created form used to solicit reporting of any adverse events, additional traumatic exposures, and drug/alcohol overdoses since the last research contact; the traumatic exposure item is taken from the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
|
4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
|
Physical Pain
기간: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.
|
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2030년 5월 31일
연구 완료 (추정된)
2030년 5월 31일
연구 등록 날짜
최초 제출
2026년 8월 12일
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- WEST 3.0 RCT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .