Status:
RECRUITING
Manage Emotions to Reduce Aggression (MERA)
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
University of South Florida
Conditions:
Stress Disorders, Post-Traumatic
Aggression
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive agg...
Detailed Description
Aggression can have devastating interpersonal and societal consequences, including incarceration, family violence, disruption of treatment-facilitating factors, and death. About 50% of Veterans with f...
Eligibility Criteria
Inclusion
- Male and female Veterans who deployed to combat zones since 9/11.
- Currently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5
- 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
- Impulsive aggression is his/her primary form of aggression, determined by the Impulsive Premeditated Aggression Scale
- 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.
- Agreement not to change psychotropic medications through the duration of the study.
Exclusion
- Currently suicidal with intent of self-harm in the last week.
- Currently homicidal with plans to hurt a specific person.
- Unable to complete self-report measures.
- Meets diagnostic criteria for bipolar disorder or psychotic disorder.
- 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.
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04793776
Start Date
January 3 2022
End Date
June 30 2026
Last Update
December 3 2025
Active Locations (2)
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1
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
2
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030