Manage Emotions to Reduce Aggression (MERA)
MERA
2 other identifiers
interventional
204
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
June 8, 2026
June 1, 2026
4.7 years
March 8, 2021
June 4, 2026
Conditions
Keywords
Outcome Measures
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.
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)
Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Other Outcomes (1)
Evidence Based Psychotherapy (EBP) Initiation
Treatment group differences in EBP initiation at 6 months posttreatment.
Study Arms (2)
Manage Emotions to Reduce Aggression (MERA)
EXPERIMENTALMERA is 3 individual 90-minute sessions delivered over 3 weeks.
Present Centered Psychotherapy (PCT)
ACTIVE COMPARATORPCT delivered in 3 individual 90-minute sessions over 3 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Boston Healthcare Systemcollaborator
- University of Houstoncollaborator
- Texas A&M Universitycollaborator
- VA Office of Research and Developmentlead
- Michael E. DeBakey VA Medical Centercollaborator
- University of South Floridacollaborator
Study Sites (2)
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon R. Miles, PhD
James A. Haley Veterans' Hospital, Tampa, FL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors will be masked to treatment assessment. Therapist will be masked to outcome data.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
January 3, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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.
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.