Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2019年5月2日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
52
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02459
- VA Boston Healthcare System
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
大体时间：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
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Karen E. Krinsley, Ph.D.、VA Boston Healthcare System
- 首席研究员：Lisa M Najavits, PhD、VA Boston Healthcare System
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2011年1月10日
首先提交符合 QC 标准的
2011年1月10日
首次发布 (估计)
2011年1月11日
研究记录更新
最后更新发布 (实际的)
2019年5月3日
上次提交的符合 QC 标准的更新
2019年5月2日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
物质使用障碍的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阳性 | 结外 NK/T 细胞淋巴瘤，鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国
Seeking Safety (SS)的临床试验
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University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University; University of Utah 和其他合作者招聘中
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel完全的气道管理 | 喉罩气道 | 光纤插管
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China Medical University HospitalChina Medical University, China; Chang Gung Memorial Hospital; National Research Program for Biopharmaceuticals...未知
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Chang Gung Memorial HospitalChina Medical University, China; China Medical University Hospital; National Science Council,... 和其他合作者未知
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Children's Hospital of PhiladelphiaFriedreich's Ataxia Research Alliance; Stealth BioTherapeutics Inc.主动，不招人