Aggression in Military Personnel (MERA)
Reducing Aggression in Military Personnel: A Randomized Clinical Trial
We propose to study if Manage Emotions to Reduce Aggression (MERA) is helpful in reducing anger and aggression in active duty service members by comparing it to self monitoring of one's anger and aggression. The proposed study has two treatment groups. The first group will receive MERA and then monitor their anger and aggression for 3 more weeks. The second group will be asked to monitor their anger and aggression for 3 weeks prior to receiving MERA. All service members will receive MERA and will be asked to self-monitor, but the order in which they are asked to complete these tasks will be randomized.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Shannon R Miles, PhD
- 电话号码：106728 8139-972-2000
- 邮箱：shannon.miles@va.gov
研究联系人备份
- 姓名：Michelle Gaudet
- 电话号码：813-485-2968
- 邮箱：Michelle.Gaudet@va.gov
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Active duty service member 18 years or older.
- Currently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R; Jackson et al., 2024) endorsing trauma exposure and a score of > 3 on at least 1 Cluster B, 1 Cluster C, 1 Cluster D, and 1 Cluster E symptom. Symptoms must be present for at least 1 month with clinically significant distress and/or functional impairment (items 23-25 with scores of > 2).
- Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by the 20-item Overt Aggression Scale (OAS; Yudofsky et al., 1986).
- Impulsive aggression is primary form of aggression, determined by the Impulsive Premeditated Aggression Scale (IPAS; Standford et al., 2001).
- Clinically significant anger determined by scores of >12 on the Dimensions of Anger Reactions (DAR-5; Forbes et al., 2014) scale.
Exclusion Criteria:
-
Currently suicidal or homicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
-
Unable to complete self-report measures based on clinical judgement.
-
Current manic episode as indicated on the Mood Disorder Questionnaire (MDQ; Hirschfeld et al., 2000) or experiencing psychotic symptoms as indicated on the Prodromal Questionnaire (PQ-16; Ising et al., 2012) requiring immediate stabilization or hospitalization (as determined by clinical assessment and judgment).
-
Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Service members receiving general mental health services or engaging in usual care will be allowed to participate.
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学习计划
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：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Manage Emotions to Reduce Aggression (MERA) X Self-Monitoring
MERA followed by Self-Monitoring. |
Three session treatment that teaches the adaptive value of emotions and emotion regulation skills. Three weeks of tracking anger and aggression and weekly check-ins with study team to assess for risk level. |
|
有源比较器：Self-Monitoring X Manage Emotions to Reduce Aggression (MERA)
Self-monitoring followed by MERA. |
Three session treatment that teaches the adaptive value of emotions and emotion regulation skills. Three weeks of tracking anger and aggression and weekly check-ins with study team to assess for risk level. |
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 |
|---|---|---|
|
Overt Aggression Scale - Modified (OAS-M)
大体时间：Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
Overt Aggression Scale (OAS; Yudofsky et al., 1986) is a 16-item self-report measure that assesses frequency of verbal and physical aggression against self, other, and objects. Investigators added 3 items to assess aggression while driving and in virtual communication (e.g. aggression while texting or emailing) and gave a blank for other aggressive behavior. Investigators adapted the instructions to rate aggression over the past week. There are 20 items on the OAS-M. Pilot data demonstrated that this adapted measure is sensitive to detect changes in aggression frequency during the 3 weeks of MERA (Miles, Kent, et al., 2020). Self-reported aggressive acts will be summed to create an OAS total frequency count of aggressive acts at each assessment, with greater scores indicating more acts of aggression in the past week. |
Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
|
State-Trait Anger Expression Inventory-2: State Anger (STAXI-2 S-Anger) Subscale
大体时间：Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
State-Trait Anger Expression Inventory-2 Subscale-Anger (STAXI-2 S-Anger; Spielberger, 2010) is a 15-item subscale from the STAXI-2 that measures anger. Investigators adapted the instructions to measure anger in the past week. Items in this subscale ask participants to indicate how much they are experiencing certain feelings and desires on a four-point scale ranging from 1 (not at all) to 4 (very much so). Scores are summed to assess the overall intensity of anger felt in the past week. The total score range is 15-60, with greater scores indicating higher levels of anger. |
Baseline to 4-week, 8-week, and 20-week post treatment assessments.
|
合作者和调查者
调查人员
- 首席研究员：Shannon Miles, PhD、James A. Haley Veterans' Hospital
出版物和有用的链接
一般刊物
- Yudofsky SC, Silver JM, Jackson W, Endicott J, Williams D. The Overt Aggression Scale for the objective rating of verbal and physical aggression. Am J Psychiatry. 1986 Jan;143(1):35-9. doi: 10.1176/ajp.143.1.35.
- Spielberger CD. STAXI-2: State-trait anger expression inventory - 2. 1999. Lutz, FL: Psychological Assessment Resources, Inc.
- Miles SR, Kent TA, Stanley M, Thompson KE, Sharp C, Niles BL, Young-McCaughan S, Mintz J, Roache JD, Litz BT, Hale WJ, Stanford MS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Manage Emotions to Reduce Aggression: A Pilot Study of a Brief Treatment to Help Veterans Reduce Impulsive Aggression. J Nerv Ment Dis. 2020 Nov;208(11):897-903. doi: 10.1097/NMD.0000000000001229.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- IRBnet #: 1937626
- HT94252510651 (其他赠款/资助编号：Department of War)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Sharing of the data collected in the conduct of the proposed project will be deposited into the National Institutes of Mental Health (NIMH) Data Archive (NDA) and the UT Health San Antonio Institutional Review Board (IRB)-approved STRONG STAR Repository (HSC2010-475H) for future use.
IPD 共享时间框架
One year after the end of the study.
IPD 共享访问标准
Any future research using Repository data will require a research protocol for the proposed study reviewed and approved by an authorized official responsible for protecting human subjects of research. The data protections for privacy and confidentiality described in the consent form will apply to any future use of stored data.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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