Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
2014年1月27日 更新者：James S. Gordon, M.D.、The Center for Mind-Body Medicine
A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).
研究概览
详细说明
The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program.
Both groups will also continue their medical treatment as usual.
The mind-body skills group intervention consists of groups of 8-10 participants.
Two formats will be offered.
(1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon.
The groups will be run for a total of 5 Saturday sessions.
Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.
研究类型
介入性
注册 (实际的)
108
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
-
-
Louisiana
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New Orleans、Louisiana、美国、70112
- Southeast Louisiana Veterans 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 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
- comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.
Exclusion Criteria:
- current uncontrolled psychotic or bipolar disorder
- significant cognitive impairment
- moderate or severe TBI
- substance dependence
- suicidal or homicidal ideation
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 |
|---|---|
|
有源比较器：标准治疗
|
May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e.
unrelated to mindfulness) psychotherapy as well as medication management.
Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.
|
|
实验性的：身心技能组
|
The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback.
These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.
|
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 |
|---|---|---|
|
PTSD checklist - military version
大体时间：Baseline; 12 weeks; 20 weeks
|
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD.
Past month symptom severity is indicated using a 5 point scale.
|
Baseline; 12 weeks; 20 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
State-Trait Anger Expression Inventory-2
大体时间：Baseline;12 weeks; 20 weeks
|
This is a 57 item consisting of a 4 point scale that measures the intensity of anger as an emotional state at a particular time (State Anger) and how often angry feelings are experienced over time as a personality trait (Trait Anger).
There are 4 additional subscales which measure the outward expression of anger (Anger Expression-Out), holding or suppressing angry feelings (Anger Expression-In); controlling angry feelings by preventing the outward expression of anger (Anger Control-Out); and controlling anger feeling by calming down (Anger Control-In)
|
Baseline;12 weeks; 20 weeks
|
|
The Pittsburgh Sleep Quality Index
大体时间：Baseline;12 weeks; 20 weeks
|
This 9 item questionnaire using a 4 point scale measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual seep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
|
Baseline;12 weeks; 20 weeks
|
|
The Patient Health Questionnaire-9
大体时间：Baseline;12 weeks; 20 weeks
|
The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.
|
Baseline;12 weeks; 20 weeks
|
|
State-Trait Anxiety Inventory
大体时间：Baseline; 12 weeks; 20 weeks
|
The State anxiety subscale will be used.
It has 20 questions and uses a 4 point scale.
|
Baseline; 12 weeks; 20 weeks
|
|
The Posttraumatic Growth Inventory
大体时间：Baseline;12 weeks; 20 weeks
|
The Posttraumatic Growth Inventory measures positive change that people can experience when they have been in a traumatic situation.
It is a 21 item self report scale that includes five subscales: relating to others, new possibilities, personal strength, spiritual challenge, and appreciation of life.
|
Baseline;12 weeks; 20 weeks
|
|
The Medical Outcomes Study Short Form SF-36
大体时间：Baseline; 12 weeks; 20 weeks
|
The SF-36 has 36 questions and measures functional status in eight dimensions: physical functioning, social functioning, role functioning-physical, role functioning-emotional, vitality, mental health, bodily pain, and general health perception.
|
Baseline; 12 weeks; 20 weeks
|
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The Inventory of Functional Impairment
大体时间：Baseline;12 weeks; 20 weeks
|
The Inventory of Functional Impairment is an 87-item self-report measure designed to assess multiple dimensions of functional impairment experienced by active duty service members and veterans.
|
Baseline;12 weeks; 20 weeks
|
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。
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
2010年9月1日
初级完成 (实际的)
2013年9月1日
研究完成 (实际的)
2013年9月1日
研究注册日期
首次提交
2010年3月24日
首先提交符合 QC 标准的
2010年3月24日
首次发布 (估计)
2010年3月25日
研究记录更新
最后更新发布 (估计)
2014年1月29日
上次提交的符合 QC 标准的更新
2014年1月27日
最后验证
2014年1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.