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Research has consistently shown that Veterans with PTSD are more likely to experience higher levels of anger and commit aggressive acts compared to Veterans without PTSD. Given the significant negative impact that anger and aggression can have on the lives of Veterans, their families, and society at large, there is a great need to examine novel interventions that could decrease anger and aggression risk with this population. Mindfulness may be one such technique, given its effectiveness in assisting individuals in regulating difficult emotions and in decreasing physiological reactivity, which have both been implicated in PTSD and aggression perpetration. Findings showing that a mindfulness intervention is effective in reducing anger and aggressive behavior would be relevant for Veterans with PTSD experiencing such difficulties and would help prevent the detrimental consequences that can come from anger and aggression among these individuals.
Military Veterans suffering from posttraumatic stress disorder (PTSD) have been shown to exhibit increases in aggressive urges, difficulties managing anger, and difficulties controlling violent behavior. Dysregulated anger and aggression can create fear and distress in spouses, family members, and friends resulting in strained and deteriorated relationships, and can have a detrimental impact on Veterans' social, occupational and other important areas of functioning. In addition, more severe forms of aggression and violent behavior (i.e., homicide) in the community have been observed among Veterans with PTSD, as recently reported in several news media outlets. The seriousness of this problem is underscored by the high rates of alcohol use observed among Veterans with PTSD which further increases anger and the risk of aggressive behavior.
Current therapeutic interventions may not be effective in reducing anger and aggressive behavior among Veterans with PTSD due to the lack of techniques that directly target symptoms most strongly associated with aggression, particularly hyperarousal and physiological reactivity. Furthermore, existing interventions may not be effective in assisting individuals achieve awareness and insight into their anger states, necessary for the effective management of anger and aggression. Mindfulness is rooted in Eastern meditation practices and has been successfully used to decrease stress, pain, anxiety, and depression. In civilian samples, mindfulness interventions have been found to be effective in reducing anger and aggression. To date, mindfulness for anger and aggression has not been examined in Veterans with PTSD.
The primary objective of the proposed investigation is to conduct a pilot randomized control trial to examine the initial efficacy of an established mindfulness intervention, Mindfulness Based Stress Reduction (MBSR) in decreasing anger and aggression in Veterans with PTSD. The proposed investigation also seeks to examine potential mechanisms of action that account for its effects. Sixty Veterans with PTSD experiencing problems with anger and aggression will be recruited. These individuals will complete a baseline assessment to assess self-reported levels of anger and aggression. They will then be randomly assigned to participate in an online (i.e., virtual) PTSD psychoeducational course or MBSR. After completing treatment, all participants will complete a post-treatment assessment to assess changes in anger and aggression.
At a later date and time, participants will also be asked to attend an in-person laboratory session where they will engage in a trauma-imagery procedure followed by a task designed to assess provoked aggression. In addition to examining whether participation in MBSR decreases self-reported levels of anger and aggression, this study will examine whether MBSR decreases aggression in participants after being exposed to trauma reminders in vivo. Potential mechanisms of action of MBSR and its effects on additional outcomes also will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. |
|
| Trauma Recovery Education Class | Active Comparator | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. |
| Measure | Description | Time Frame |
|---|---|---|
| State Anger Scale | Self-report measure of overall state anger using the State-Trait Anger Expression Inventory-2. Score range: 15-60; higher scores indicate greater state anger. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Trait Anger Scale | Self-report measure of trait anger using the State-Trait Anger Expression Inventory-2. Score range: 10-40; higher scores indicate greater trait anger. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Anger Expression In | Self-report measure of anger expression inward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of experiencing anger but not expressing (i.e., suppressing) anger. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Anger Expression Out | Self-report measure of anger expression outward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of expressing anger verbally or physically. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Anger Control In |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin Conductance Levels | Changes in skin conductance levels during the trauma narrative portion of the lab session. | within 8 weeks following the completion of either of the two treatments |
| Heart Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorig Kachadourian, PhD MA | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Based Stress Reduction | Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. |
| FG001 | Trauma Recovery Education Class | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. Trauma Recovery Education Class: Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Based Stress Reduction | Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | State Anger Scale | Self-report measure of overall state anger using the State-Trait Anger Expression Inventory-2. Score range: 15-60; higher scores indicate greater state anger. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
|
Adverse event data were collected from the time of study entry until the end of study participation, approximately 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Based Stress Reduction | Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
The project was delayed in 2017 due to a hiring freeze. Also, due to the COVID-19 pandemic: 1) In 2020 the study was suspended for one year, 2) procedures had to be modified-all research sessions had to be conducted virtually (as opposed to in-person), and 3) the in-person laboratory session was either not conducted or delayed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorig Kachadourian | VA CONNECTICUT HEALTHCARE SYSTEM | 203-932-5711 | 7064, 5036 | lorig.kachadourian@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2016 | Mar 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2016 | Mar 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000374 | Aggression |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| Trauma Recovery Education Class | Behavioral | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. |
|
|
Self-report measure of anger control inward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of attempting to control anger feelings by calming down or cooling off.
| Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Anger Control Out | Self-report measure of anger control outward using the State-Trait Anger Expression Inventory. Score range: 8-32; higher scores indicate greater frequency of controlling outward expression of angry feelings. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Anger Expression Index | Total Anger score on the STAXI-2. Score range: 0-96; higher scores indicate greater expression of anger. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Buss Perry Total Aggression Score | Self-report measure of total aggression using the Buss-Perry Aggression Questionnaire. Scores range from 29-203; greater scores indicate greater total aggression. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Buss Perry Physical Aggression | self-report measure assessing physical aggression using Buss Perry Aggression Questionnaire. Scores range from 9-63; greater scores indicate greater total physical aggression. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Buss Perry Verbal Aggression Score | self-report measure assessing verbal aggression using Buss Perry Aggression Questionnaire. Scores range from 5-35; greater scores indicate greater total verbal aggression. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Buss Perry Anger Scale | self-report measure of anger using the Buss Perry Aggression Questionnaire. Scores range from 7-49; greater scores indicate greater total anger. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Buss Perry Hostility Scale | self-report measure of hostility using the Buss Perry Aggression Questionnaire. Scores range from 8-56; greater scores indicate greater total hostility. | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
| Provoked Aggression Subscale 1 | An experimental lab-based paradigm designed to assess provoked aggression, the Taylor Reaction Time Task. This subscale determines whether participants' aggression increased, decreased, or remained the same across four blocks of trials (six trials within each block). Scores range from 0-11 within each trial, with higher scores indicating worse outcome. Each of the six trials within each block are averaged together. | within 8 weeks following the completion of either of the two treatments |
| Provoked Aggression Subscale 2 | An experimental lab-based paradigm designed to assess provoked aggression, the Taylor Reaction Time Task. This subscale determines participants' initial levels of aggression. Participants can choose from the following response options: 0, 1, 2, 3, 4, 5, 6, 7,8, 9, 10 or 20, with higher scores indicating greater initial levels of aggression. | within 8 weeks following the completion of either of the two treatments |
Changes in heart rate during the trauma narrative portion of the lab session.
| within 8 weeks following the completion of either of the two treatments |
| BG001 | Trauma Recovery Education Class | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. Trauma Recovery Education Class: Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| STAXI State Anger Scale | Score range: 15-60; higher scores indicate greater state anger | Mean | Standard Deviation | units on a scale |
|
| STAXI Trait Anger Scale | Score range: 10-40; higher scores indicate greater trait anger | Mean | Standard Deviation | units on a scale |
|
| STAXI Anger Expression In | Score range: 8-32; higher scores indicate greater frequency of experiencing anger but not expressing (i.e., suppressing) anger. | Mean | Standard Deviation | units on a scale |
|
| STAXI Anger Expression Out | Score range: 8-32; higher scores indicate greater frequency of expressing anger verbally or physically. | Mean | Standard Deviation | units on a scale |
|
| STAXI Anger Control In | Score range: 8-32; higher scores indicate greater frequency of attempting to control anger feelings by calming down or cooling off. | Mean | Standard Deviation | units on a scale |
|
| STAXI Anger Control Out | Score range: 8-32; higher scores indicate greater frequency of controlling outward expression of angry feelings. | Mean | Standard Deviation | units on a scale |
|
| STAXI Anger Expression Index | Score range: 0-96; higher scores indicate greater expression of anger. | Mean | Standard Deviation | units on a scale |
|
| Buss Perry Aggression Quest Total Score | Scores range from 29-203; greater scores indicate greater total aggression. | Mean | Standard Deviation | units on a scale |
|
| Buss Perry Aggression Quest Physical Aggression | Scores range from 9-63; greater scores indicate greater total physical aggression. | Mean | Standard Deviation | units on a scale |
|
| Buss Perry Aggression Questionnaire Verbal Aggression | Scores range from 5-35; greater scores indicate greater total verbal aggression. | Mean | Standard Deviation | units on a scale |
|
| Buss Perry Aggression Questionnaire Anger | Scores range from 7-49; greater scores indicate greater total anger. | Mean | Standard Deviation | units on a scale |
|
| Buss Perry Aggression Questionnaire Hostility | Scores range from 8-56; greater scores indicate greater total hostility. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Trauma Recovery Education Class | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. Trauma Recovery Education Class: Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. |
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| Primary | Trait Anger Scale | Self-report measure of trait anger using the State-Trait Anger Expression Inventory-2. Score range: 10-40; higher scores indicate greater trait anger. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Anger Expression In | Self-report measure of anger expression inward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of experiencing anger but not expressing (i.e., suppressing) anger. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Anger Expression Out | Self-report measure of anger expression outward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of expressing anger verbally or physically. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Anger Control In | Self-report measure of anger control inward using the State-Trait Anger Expression Inventory-2. Score range: 8-32; higher scores indicate greater frequency of attempting to control anger feelings by calming down or cooling off. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Anger Control Out | Self-report measure of anger control outward using the State-Trait Anger Expression Inventory. Score range: 8-32; higher scores indicate greater frequency of controlling outward expression of angry feelings. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Anger Expression Index | Total Anger score on the STAXI-2. Score range: 0-96; higher scores indicate greater expression of anger. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Buss Perry Total Aggression Score | Self-report measure of total aggression using the Buss-Perry Aggression Questionnaire. Scores range from 29-203; greater scores indicate greater total aggression. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Buss Perry Physical Aggression | self-report measure assessing physical aggression using Buss Perry Aggression Questionnaire. Scores range from 9-63; greater scores indicate greater total physical aggression. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Buss Perry Verbal Aggression Score | self-report measure assessing verbal aggression using Buss Perry Aggression Questionnaire. Scores range from 5-35; greater scores indicate greater total verbal aggression. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Buss Perry Anger Scale | self-report measure of anger using the Buss Perry Aggression Questionnaire. Scores range from 7-49; greater scores indicate greater total anger. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Buss Perry Hostility Scale | self-report measure of hostility using the Buss Perry Aggression Questionnaire. Scores range from 8-56; greater scores indicate greater total hostility. | Not all participants completed assessments at all time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3 weeks of treatment, after 6 weeks of treatment, within 8 weeks following the completion of either of the two treatments (i.e., post-treatment), and within 5 months after completing the post-treatment assessment |
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| Primary | Provoked Aggression Subscale 1 | An experimental lab-based paradigm designed to assess provoked aggression, the Taylor Reaction Time Task. This subscale determines whether participants' aggression increased, decreased, or remained the same across four blocks of trials (six trials within each block). Scores range from 0-11 within each trial, with higher scores indicating worse outcome. Each of the six trials within each block are averaged together. | Number of participants analyzed is smaller than the total number of participants reported in Participant Flow as not all participants were able to/agreed to attend the in-person lab assessment (and therefore complete the Taylor Reaction Time task) due to COVID-19 restrictions | Posted | Mean | Standard Deviation | units on a scale | within 8 weeks following the completion of either of the two treatments |
|
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| Primary | Provoked Aggression Subscale 2 | An experimental lab-based paradigm designed to assess provoked aggression, the Taylor Reaction Time Task. This subscale determines participants' initial levels of aggression. Participants can choose from the following response options: 0, 1, 2, 3, 4, 5, 6, 7,8, 9, 10 or 20, with higher scores indicating greater initial levels of aggression. | Number of participants analyzed is smaller than the total number of participants reported in Participant Flow as not all participants were able to/agreed to attend the in-person lab assessment (and therefore complete the Taylor Reaction Time task) due to COVID-19 restrictions | Posted | Median | Inter-Quartile Range | units on a scale | within 8 weeks following the completion of either of the two treatments |
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| Other Pre-specified | Skin Conductance Levels | Changes in skin conductance levels during the trauma narrative portion of the lab session. | Not Posted | within 8 weeks following the completion of either of the two treatments | Participants |
| Other Pre-specified | Heart Rate | Changes in heart rate during the trauma narrative portion of the lab session. | Not Posted | within 8 weeks following the completion of either of the two treatments | Participants |
| 0 |
| 35 |
| 2 |
| 35 |
| 0 |
| 35 |
| EG001 | Trauma Recovery Education Class | Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. Trauma Recovery Education Class: Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually. | 0 | 26 | 1 | 26 | 0 | 26 |
| Self-injury | Psychiatric disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D004191 |
| Behavioral Disciplines and Activities |
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