MARI 随机临床试验 (MARI)
退伍军人移动愤怒减少干预的随机对照试验
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.
研究概览
地位
详细说明
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). In Veterans, problematic anger is associated with numerous negative psychosocial outcomes, including poor functional outcomes (both social and occupational), family discord, aggression, road rage, and suicide risk. Anger can also impede successful outcomes from PTSD treatment. Given the high prevalence of anger problems among Veterans with PTSD and the associated functional impairments, there is a clear need to develop innovative and effective anger interventions to improve functional outcomes. Use of mobile health (mHealth) technology could provide a low-cost method to increase the reach of anger management treatments to this high-need group of Veterans.
One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias, i.e., a tendency to interpret ambiguous interpersonal situations as hostile. By reducing hostile interpretation bias, the investigators can reduce problematic anger and aggression and improve functional outcomes. A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted. The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD.
A randomized controlled trial (RCT) will be conducted, in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention (MARI) or a health education condition (HED). The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.
The proposed research project will address the following Specific Aims: Aim 1: To evaluate the efficacy of MARI on anger outcomes (e.g., hostile interpretation bias, problematic anger) measured at post-treatment, 3-months, and 6-months post treatment; Aim 2: To evaluate the efficacy of MARI on functional improvements (i.e., psychosocial functioning, quality of life) and self-harm measured at post-treatment, 3-months, and 6-months post treatment; and Exploratory Aim: To explore whether changes in hostile interpretation bias (proposed treatment mechanism) mediate functional improvements.
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：Kirsten H Dillon, PhD
- 电话号码：(919) 286-0411
- 邮箱：Kirsten.Dillon@va.gov
研究联系人备份
- 姓名：Angela C Kirby, MS
- 电话号码：7456 (919) 286-0411
- 邮箱：angela.kirby@va.gov
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27705-3875
- 招聘中
- Durham VA Medical Center, Durham, NC
-
接触：
- Kirsten H Dillon, PhD
- 电话号码：(919) 286-0411
- 邮箱：Kirsten.Dillon@va.gov
-
首席研究员：
- Kirsten H Dillon, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Veterans diagnosed with Post-traumatic stress disorder (PTSD), established via chart review and a score of greater than or equal to 33 on the PTSD Checklist for DSM-5 (PCL-5)
- Reporting a score of greater than or equal to 12 on the 5-item Dimensions of Anger Reactions Scale
- Have not had any changes to type or dose of psychiatric medications for 3 months, with no plans to make adjustments in the next 6 months
- Able to read at least 6th grade level material
Exclusion Criteria:
- Currently in a period of active psychosis or mania
- Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
- Have used the Mobile Anger Reduction Intervention (MARI) application before as part of another research study
- Receiving (or plan to receive) other anger management psychotherapy or trauma-focused therapy for PTSD (i.e., prolonged exposure, cognitive processing therapy during the course of the study
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Mobile Anger Reduction Intervention (MARI)
Participants in this arm will download the MARI application (app) on their own smart phone device and will use the app for a period of 4 weeks. |
This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will download the MARI app and be instructed to complete at least 5 treatment sessions each week for a period of 4 weeks. Each session takes approximately 10 minutes. The app also includes a Nightly Diary to track symptoms, a calendar to program session reminders, and a My Progress feature to track use and performance. |
|
有源比较器：Health Education Condition (HED)
Participants in this arm will download the HED application (app) on their own smart phone device and will use the app for a period of 4 weeks. |
This is a mobile application that delivers videos with psychoeducation about healthy habits and selfcare for general wellness. Participants will download the HED app and be instructed to use it at least 5 times a week for a period of 4 weeks. |
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 |
|---|---|---|
|
number of participants below the clinical cut off for problematic anger
大体时间：Post-treatment (approx. one month after baseline assessment)
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
Post-treatment (approx. one month after baseline assessment)
|
|
number of participants below the clinical cut off for problematic anger
大体时间：6-month follow-up
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
6-month follow-up
|
|
number of participants below the clinical cut off for problematic anger
大体时间：3-month follow-up
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
3-month follow-up
|
|
number of participants with decreased hostile interpretation bias scores
大体时间：from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with decreased hostile interpretation bias scores
大体时间：from baseline to 3-month follow-up
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with decreased hostile interpretation bias scores
大体时间：from baseline to 6-month follow-up
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to 6-month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
number of participants with decreased psychosocial impairment scores
大体时间：from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with decreased psychosocial impairment scores
大体时间：from baseline to 3-month follow-up
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with decreased psychosocial impairment scores
大体时间：from baseline to 6-month follow-up
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to 6-month follow-up
|
|
number of participants with improved quality of life
大体时间：from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with improved quality of life
大体时间：from baseline to 3-month follow-up
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with improved quality of life
大体时间：from baseline to 6-month follow-up
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to 6-month follow-up
|
|
number of participants with reduced suicidal ideation
大体时间：from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with reduced suicidal ideation
大体时间：from baseline to 3-month follow-up
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with reduced suicidal ideation
大体时间：from baseline to 6-month follow-up
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to 6-month follow-up
|
合作者和调查者
调查人员
- 首席研究员：Kirsten H Dillon, PhD、Durham VA Medical Center, Durham, NC
研究记录日期
研究主要日期
学习开始 (实际的)
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
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.