NCT04793776 Manage Emotions to Reduce Aggression (MERA)
| NCT ID | NCT04793776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Stress Disorders, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2022-01-03 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.
Eligibility 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.
Contact & Investigator
Shannon R. Miles, PhD
PRINCIPAL INVESTIGATOR
James A. Haley Veterans' Hospital, Tampa, FL
Frequently Asked Questions
Who can join the NCT04793776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Stress Disorders, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04793776 currently recruiting?
Yes, NCT04793776 is actively recruiting participants. Contact the research team at Shannon.Miles@va.gov for enrollment information.
Where is the NCT04793776 trial being conducted?
This trial is being conducted at Tampa, United States, Houston, United States.
Who is sponsoring the NCT04793776 clinical trial?
NCT04793776 is sponsored by VA Office of Research and Development. The principal investigator is Shannon R. Miles, PhD at James A. Haley Veterans' Hospital, Tampa, FL. The trial plans to enroll 204 participants.