NCT02882802

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

July 22, 2016

Results QC Date

April 30, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

angeraggression

Outcome Measures

Primary Outcomes (14)

  • 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

    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

Other Outcomes (2)

  • Skin Conductance Levels

    within 8 weeks following the completion of either of the two treatments

  • Heart Rate

    within 8 weeks following the completion of either of the two treatments

Study Arms (2)

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.

Behavioral: Mindfulness Based Stress Reduction

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.

Behavioral: Trauma Recovery Education Class

Interventions

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.

Also known as: MBSR
Mindfulness Based Stress Reduction

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.

Also known as: TREC
Trauma Recovery Education Class

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must meet current Diagnostic and Statistical Manual of Mental Disorders (5th edition) diagnostic criteria for PTSD (participants with sub-threshold levels of PTSD will also be allowed to participate).
  • Participants must also indicate current difficulties with anger and aggression.

You may not qualify if:

  • Participants with a current diagnosis of psychotic disorder or current substance use disorder with severe symptoms.
  • Participants diagnosed with bipolar II disorder without psychotic features and/or individuals diagnosed with bipolar disorder who are well-controlled on medication will be allowed to participate. Individuals with bipolar disorder who do not fall into either of these categories will be excluded.
  • Participants also must not have a seizure disorder.
  • Participants are allowed to be taking psychotropic medications, however they must be on a stable dose for at least 2 months.
  • Participants who do not have a working and active e-mail account and access to a smart phone or computer will be excluded.
  • Finally, participants must not currently be receiving concurrent individual therapy or group therapy focused on anger and aggression, must not be currently receiving any evidence-based treatment for PTSD, and must not currently be participating in the modified TREC group offered at the West Haven VA Medical Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Aggression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Lorig Kachadourian
Organization
VA CONNECTICUT HEALTHCARE SYSTEM

Study Officials

  • Lorig Kachadourian, PhD MA

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 30, 2016

Study Start

December 1, 2017

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations