ClinicalTrials.gg
Active, not recruitingNCT04793776MERAUpdated Oct 21, 2026

Manage Emotions to Reduce Aggression (MERA)

An interventional study of Manage Emotions to Reduce Aggression and Present Centered Psychotherapy in Stress Disorders, Post-Traumatic, Aggression and Emotion Regulation, sponsored by VA Office of Research and Development. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Updated Oct 21, 2026Now Active, not recruitingStudy documents posted+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
233
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with 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.

Read the 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 full and subthreshold posttraumatic stress disorder (PTSD) reported engaging in aggression after returning from deployment. This level of aggression is higher than Veterans without PTSD5 and civilians with PTSD. Current psychotherapy options to reduce aggression include present centered therapies (PCTs), anger management, and evidence based psychotherapies (EBP) for PTSD. Anger management reduces aggression in civilian samples with small to moderate effect sizes. However, few anger management treatment studies have examined Veterans with PTSD and measured acts of aggression. Consistently, VA clinicians also provide PCTs and EBP for PTSD. It is unknown how effectively PCTs reduce aggression. Unfortunately, even with gold standard EBP for PTSD Veterans only experience small to moderate reductions in aggression. While any decline is an improvement, these treatments leave room for novel methods to help Veterans reduce aggression.

Emotion regulation ability may be a key to reducing aggression. The team revealed that among Veterans with PTSD and aggression, impulsive aggression (emotionally charged, reactive, and uncontrolled) is more common than premeditated aggression (deliberate, instrumental, and planned). Emotion dysregulation, or the inability to detect emotions, accept emotions, and/or engage in content-appropriate regulation, is related to impulsive aggression and to PTSD severity. The investigators demonstrated that emotion dysregulation fully mediated the relationship between PTSD and impulsive aggression in Veterans.

Increasing emotion regulation ability of many emotions is an innovative method to reduce aggression. Full-length treatments that incorporate emotion regulation training (8-12 sessions) have augmented EBP for PTSD and improved Veterans' emotion regulation skills. However, a brief format is needed for returning Veterans. Eight weeks of treatment, particularly when offered prior to EBP, is an unfeasible commitment for many Veterans who are reintegrating into their communities. Additionally, most drop outs from EBP for PTSD occur prior to session three making the initial sessions a critical time for skill development. Finally, Veterans have experienced wait times to receive treatment due to the growing population of returning Veterans. To address these challenges, the team developed a 3-session emotion regulation treatment, called Manage Emotions to Reduce Aggression (MERA). Male combat Veterans who completed MERA in an open trial (N=20) endorsed the brief model, utilized the skills, and found the treatment helpful at the 4-week follow up. MERA had a low dropout rate of 8% from active treatment. MERA completers demonstrated a medium to large pre- to post-treatment reduction in frequency of aggression (Cohen's d = 0.73).

The goal of the proposed study is to conduct a 2-site randomized clinical trial (RCT) to test if MERA is efficacious at reducing aggression and emotion dysregulation compared to 3 sessions of PCT, which is often the standard of care for Veterans with aggression.

Aim 1: Determine if MERA results in reductions in frequency of impulsive aggression compared to PCT in Veterans (N = 204) with subthreshold or full PTSD who have deployed for combat operations since 9/11.

Hypothesis 1: MERA will demonstrate statistically significant greater reductions in frequency of aggression (measured by the Overt Aggression Scale) relative to PCT at the 2-month posttreatment assessment.

Aim 2: Examine if MERA reduces emotion dysregulation relative to PCT. Hypothesis 2: MERA will demonstrate statistically significant greater reductions in emotion dysregulation (measured by Difficulties in Emotion Regulation Scale) relative to PCT at the posttreatment assessment.

Exploratory Aim. Veterans who learn to regulate their emotions rather than avoid them may be more likely to engage in EBP for PTSD. The investigators will examine if Veterans who complete MERA have higher rates of EBP initiation compared to Veterans who complete PCT. Exploratory Hypothesis: Veterans who complete MERA will have statistically significant higher rates of EBP initiation than Veterans who complete PCT.

If the hypotheses are supported, the VA will have a brief treatment that can help Veterans manage their aggression by directly targeting emotion dysregulation. MERA may also be applicable to Veterans with emotion dysregulation and other psychological disorders.

02

Conditions studied

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

Keywords

  • Stress Disorders, Post-Traumatic
  • Aggression
  • Emotion Regulation
  • Veterans
  • Psychotherapy
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 233 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 2, 2026. See what changed

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female Veterans who deployed to combat zones since 9/11
  2. Currently meets criteria for full or subthreshold post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with 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, determined by the Clinician-Administered PTSD Scale for
  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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
233 participants (actual)

Study arms

  • Experimental
    Manage Emotions to Reduce Aggression (MERA)

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

    Behavioral: Manage Emotions to Reduce Aggression

  • Active comparator
    Present Centered Psychotherapy (PCT)

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

    Behavioral: Present Centered Psychotherapy

Interventions

  • BehavioralManage 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.

    Also known as: MERA

  • BehavioralPresent 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.

    Also known as: PCT

06

What researchers measure

Primary outcomes

  1. Change in Overt Aggression Scale (OAS)

    Overt Aggression Scale is a 17-item self-report measure that assesses frequency of verbal and physical aggression against self, other, and objects and while driving over the past week. Veterans' self-reported aggressive acts will be summed to create an OAA total score. Minimum score = 0; there is no maximum score as Veterans can report as many episodes of aggression as they engage in.

    Time frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).

Secondary outcomes

  1. Change in Difficulties in Emotion Regulation Scale (DERS)

    Difficulties in Emotion Regulation Scale (16) is a 36-item self-report measure with 6 different emotion-dysregulation factors: nonacceptance of emotional responses, difficulties engaging in goal directed behaviors, impulse-control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Scoring is based on how well the item describes the individual in the past month, from 1 (almost never) to 5 (almost always). Minimum score = 36; Maximum score = 180. Higher scores represent more emotion dysregulation.

    Time frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).

Other outcomes

  1. Evidence Based Psychotherapy (EBP) Initiation

    Initiation is defined as attending at least 1 Prolonged Exposure, Cognitive Processing Therapy, or Eye Movement Desensitization and Reprocessing session. EBP for PTSD initiation is assessed at 6 months posttreatment via chart review. Scores can either be 0 = Did not begin EBP or 1 = began EBP.

    Time frame: Treatment group differences in EBP initiation at 6 months posttreatment.

07

Study locations

2 sites
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Final data sets underlying publications resulting from the proposed research will be shared outside VA in electronic format through the mechanism(s) indicated below. A De-identified, Anonymized Dataset will be created and shared. Final de-identified data sets underlying publications resulting from the proposed research will be available outside the VA using the following mechanism, electronic format through e-mail upon request, after results are published. Data sets will also be available through collaborators and other investigators upon request prior to publication.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: After results of study are published.

Access criteria: After results of study are published and according to the VA record control schedule, which is currently a maximum of 6 years.

09

Updates

2 registry updates since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Enrollment
204 (estimated)→233 (actual)
Oct 2, 2026
Eligibility
1 inclusion criterion edited, 1 added, 1 removed
What changed in the criteria
Inclusion criteria
  • RemovedCurrently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5
  • AddedCurrently meets criteria for full or subthreshold post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with 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, determined by the Clinician-Administered PTSD Scale for DSM-5
  • EditedEach 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.
Oct 2, 2026
Documents
Oct 21, 2026
Show all 2 updates
  1. Oct 21, 2026
    Documents Informed consent form ↗ posted
    + 2 other changes: verification date and date precision
  2. Oct 2, 2026
    Recruiting→Active, not recruiting
    Enrollment 204 (estimated)→233 (actual)
    Eligibility 1 inclusion criterion edited, 1 added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedCurrently meets criteria for full or subthreshold PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5
    • AddedCurrently meets criteria for full or subthreshold post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with 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, determined by the Clinician-Administered PTSD Scale for DSM-5
    • EditedEach 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.
    + 5 other changes: identifiers, verification date, description, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04793776
Collaborators
Michael E. DeBakey VA Medical Center, University of South Florida, VA Boston Healthcare System, University of Houston, Texas A&M University
Responsible party
Sponsor
First posted
Mar 11, 2021
Start date
Jan 3, 2022
Primary completion
Oct 1, 2026
Completion
Dec 30, 2026 (estimated)
Last update
Oct 21, 2026

Study contacts

Shannon R. Miles, PhD
principal investigator · James A. Haley Veterans' Hospital, Tampa, FL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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