Recruiting

MERA

Sponsor:

VA Office of Research and Development

Code:

NCT04793776

Conditions

Stress Disorders, Post-Traumatic

Aggression

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Manage Emotions to Reduce Aggression

Present Centered Psychotherapy

Study Details

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.

Conditions

Stress Disorders, Post-Traumatic

Aggression

Emotion Regulation

Study ID

NCT04793776

Start date

Jan 3, 2022

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Manage Emotions to Reduce Aggression (MERA)

MERA is 3 individual 90-minute sessions delivered over 3 weeks.

active comparator: Present Centered Psychotherapy (PCT)

PCT delivered in 3 individual 90-minute sessions over 3 weeks.

Interventions

Manage Emotions to Reduce Aggression

MERA begins with education about the adaptive nature of emotions, how childhood and military experiences can influence emotion regulation, and how combat requires different emotion regulation strategies than most civilian environments. MERA use modeling and practice with feedback to teach cognitive-behavioral and acceptance-based emotion regulation skills.

Present Centered Psychotherapy

PCT will serve as the comparison group. PCT assists Veterans in understanding and coping with current difficulties, such as aggression, but does not provide systematic training in emotion regulation skills.

Primary outcome measure

  • Change in Overt Aggression Scale (OAS) [ Time Frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks). ]

Central Contacts and Locations

Central contacts

Locations

James A. Haley Veterans' Hospital, Tampa, FL

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Shannon R. Miles, PhD

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Stress Disorders, Post-Traumatic
  • Aggression
  • Emotion Regulation
  • Veterans
  • Psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-08.