Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2019년 5월 2일 업데이트: Karen Krinsley, VA Boston Healthcare System
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.
연구 개요
상세 설명
This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD.
CC helps clients explore the past as a step in their recovery process.
It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings.
It has particular relevance for VA in that many veterans suffer from PTSD and SUD.
The new model demonstrated positive results in two pilot studies.
연구 유형
중재적
등록 (실제)
52
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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Massachusetts
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Boston, Massachusetts, 미국, 02459
- VA Boston Healthcare System
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
- Have used a substance in the 60 days prior to intake
- Outpatient
- Plan to stay in Boston for the next 6 months
- If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
- Have a stable mailing address and live nearby enough to come to VA Boston for treatment
- Able to sign informed consent
- Willing to participate in all assessments and urine testing
- Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns
Exclusion Criteria:
- Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
- Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
- Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
- Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
- The patient is mandated to treatment
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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활성 비교기: Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
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Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD.
It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders.
In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
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실험적: Creating Change (CC)
17 sessions of past-focused Creating Change
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Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD.
It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format.
The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD symptoms assessed via self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD diagnosis as assessed by a trained interviewer
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Alcohol use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Drug use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
Urinanlysis/breathalyzer will be obtained to verify ASI self-report.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
기간: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Karen E. Krinsley, Ph.D., VA Boston Healthcare System
- 수석 연구원: Lisa M Najavits, PhD, VA Boston Healthcare System
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
2011년 1월 1일
기본 완료 (실제)
2015년 3월 1일
연구 완료 (실제)
2015년 3월 1일
연구 등록 날짜
최초 제출
2011년 1월 10일
QC 기준을 충족하는 최초 제출
2011년 1월 10일
처음 게시됨 (추정)
2011년 1월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 2일
마지막으로 확인됨
2019년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SPLA-CX000308-01 (VA CSRD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .
Seeking Safety (SS)에 대한 임상 시험
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Treatment InnovationsNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)완전한
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VA Office of Research and Development완전한
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University of California, Los AngelesDuke University모병
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M.D. Anderson Cancer Center모병
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China Medical University HospitalChina Medical University, China; Chang Gung Memorial Hospital; National Research Program...알려지지 않은
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Chang Gung Memorial HospitalChina Medical University, China; China Medical University Hospital; National Science Council... 그리고 다른 협력자들알려지지 않은
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University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University; University... 그리고 다른 협력자들모병