Emotion regulation program to help veterans reduce aggression
Manage Emotions to Reduce Aggression - MERA: A Brief Aggression Treatment for Veterans With PTSD Symptoms
NA · VA Office of Research and Development · NCT04793776
This study tests a new three-session program to help veterans with PTSD learn to manage their emotions and reduce aggressive behavior.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT04793776 on ClinicalTrials.gov |
What this trial studies
This research focuses on veterans suffering from post-traumatic stress disorder (PTSD) who struggle with impulsive aggression. It compares a three-session emotion regulation treatment called Manage Emotions to Reduce Aggression (MERA) against a control group to assess its effectiveness in reducing aggressive behaviors. The study aims to enhance veterans' emotional coping skills, thereby preparing them for further PTSD treatment. By addressing the underlying issues of emotion dysregulation, the research seeks to provide a novel approach to managing aggression in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female veterans who have deployed to combat zones since 9/11 and meet criteria for full or subthreshold PTSD while exhibiting impulsive aggression.
Not a fit: Patients who are currently suicidal or homicidal, or those unable to complete self-report measures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce impulsive aggression in veterans, improving their quality of life and treatment outcomes for PTSD.
How similar studies have performed: While there have been studies on anger management and PTSD treatments, this specific approach focusing on emotion regulation in veterans is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female Veterans who deployed to combat zones since 9/11. 2. Currently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5 3. Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by the Overt Aggression Scale 4. Impulsive aggression is his/her primary form of aggression, determined by the Impulsive Premeditated Aggression Scale 5. Each Veteran must allow an independent aggression rater (live-in partner, family member, or roommate above 18 years of age)\] verify the number of aggressive acts, using the Overt Aggression Scale. 6. Agreement not to change psychotropic medications through the duration of the study. Exclusion Criteria: 1. Currently suicidal with intent of self-harm in the last week. 2. Currently homicidal with plans to hurt a specific person. 3. Unable to complete self-report measures. 4. Meets diagnostic criteria for bipolar disorder or psychotic disorder. 5. Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Veterans receiving general mental health services or engaging in usual care will be allowed to participate.
Where this trial is running
Tampa, Florida and 1 other locations
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States (RECRUITING)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Shannon R. Miles, PhD — James A. Haley Veterans' Hospital, Tampa, FL
- Study coordinator: Shannon R Miles, PhD
- Email: Shannon.Miles@va.gov
- Phone: (813) 972-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Disorders, Post-Traumatic, Aggression, Emotion Regulation, Veterans, Psychotherapy