Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD
2016年9月6日 更新者：VA Office of Research and Development
Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD
The purpose of this study is to examine whether tobacco affects recovery from PTSD.
There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to explore how tobacco use and tobacco withdrawal symptoms change during PTSD treatment.
研究概览
详细说明
The proposed research aims to examine the effect of tobacco on PTSD symptoms and PTSD recovery as well as the effect of PTSD recovery on tobacco use.
This study has 3 aims: (1) to evaluate whether tobacco use interferes with recovery from PTSD during empirically based, trauma focused PTSD treatment.
(2) To gather preliminary data about whether tobacco use alleviates PTSD symptoms among continued tobacco users vs. recent quitters.
(3) To explore the impact of recovery from PTSD treatment on tobacco use quantity and frequency, tobacco withdrawal symptoms, and craving for tobacco.
To test these aims, the investigators propose a randomized two group design where 75 participants are assigned to receive either tobacco treatment (Contingency Management plus Cognitive Behavioral Therapy) or control treatment (Health Education) before completing Cognitive Processing Therapy (CPT) for PTSD.
Study outcome variables will be PTSD symptom severity following CPT, PTSD symptom severity during tobacco cessation treatment, and tobacco use and tobacco withdrawal during CPT.
研究类型
介入性
注册 (实际的)
19
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
-
-
Massachusetts
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Boston、Massachusetts、美国、02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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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 及以上 (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:
- current tobacco use (a urine cotinine level 200ng/ml),
- motivation to quit (measured by the 7 on the Biener Contemplation ladder)
- and a current diagnosis of PTSD [as diagnosed by the Clinician Administered PTSD Scale for DSM-5]
Exclusion Criteria:
- Exclusion criteria will include current participation in another research study, history of bipolar I disorder,
- schizophreniform disorders except for psychosis NOS due to presence of trauma-related sensory hallucinations,
- cognitive impairment (<25 of the Mini Mental State Exam),
- current suicidality/homicidality requiring clinical intervention or a suicide attempt in the past year,
- inability to provide reliable study data (e.g., provide an adulterated urine sample,
- provide misinformation to study staff including stating differing information to two or more staff members,
- attempt to misrepresent self in order to avoid being excluded from the study,
- inability to answer study questions which are used to determine eligibility),
- current non-tobacco substance use disorder (abuse or dependence or a positive drug screen; participants who have been abstinent for greater than 3 months will be allowed to participate),
- participation within the past 6 months in trauma-focused therapy (e.g., Prolonged Exposure, Cognitive Processing Therapy),
- current use of tobacco cessation pharmacotherapy (i.e., nicotine replacement therapy or varenicline),
- current use of benzodiazepines
- serious or uncontrolled medical condition precluding unaided tobacco cessation attempts,
- pregnancy,
- a recent change in psychiatric medications (change occurred <2 months prior to entering the study),
- current participation in another research study.
- In addition, participants must agree to keep psychiatric medication doses stable for the duration of the study (except for dose adjustments for changes in medication blood levels due to tobacco cessation), unless there is a concern for participant safety.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：tobacco treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
|
|
假比较器：health education treatment
Participants will be provided education on a variety of health topics and will set health goals around each topic
|
Participants will be provided education on a variety of health topics and will set health goals around each topic
|
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 |
|---|---|---|
|
Clinician Administered PTSD Scale
大体时间：end of 6 week PTSD treatment
|
posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
|
end of 6 week PTSD treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Abstinent From Tobacco Use
大体时间：end of treatment
|
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
|
end of treatment
|
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：Sandra Japuntich, PhD、VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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
2014年12月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2013年9月26日
首先提交符合 QC 标准的
2013年12月9日
首次发布 (估计)
2013年12月16日
研究记录更新
最后更新发布 (估计)
2016年10月27日
上次提交的符合 QC 标准的更新
2016年9月6日
最后验证
2016年9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.