Clinical trial NCT04793776: Manage Emotions to Reduce Aggression (MERA)
Official title: Manage Emotions to Reduce Aggression - MERA: A Brief Aggression Treatment for Veterans With PTSD Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Aggression
Emotion Regulation
Keywords: Stress Disorders, Post-Traumatic
Aggression
Emotion Regulation
Veterans
Psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Michael E. DeBakey VA Medical Center
name: University of South Florida
name: VA Boston Healthcare System
name: University of Houston
name: Texas A&M University
First posted: 2021-03-11
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized clinical trial (RCT) is designed to examine if a brief emotion regulation treatment, MERA, is efficacious at reducing aggression compared to present centered therapy (PCT) in Veterans with full or subthreshold PTSD. The investigators will use a parallel group RCT design, a 1:1 allocation ratio, and a superiority (MERA \> PCT) framework. The study will follow the SPIRIT 2013 Checklist that is recommended for RCT protocols.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change in Overt Aggression Scale (OAS)
timeFrame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Secondary outcomes:
measure: Change in Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Other outcomes:
measure: Evidence Based Psychotherapy (EBP) Initiation
timeFrame: Treatment group differences in EBP initiation at 6 months posttreatment.
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Shannon R. Miles, PhD
role: PRINCIPAL_INVESTIGATOR
References: