Manage Emotions to Reduce Aggression (MERA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manage Emotions to Reduce Aggression
BehavioralMERA 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
BehavioralPCT 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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Manage Emotions to Reduce Aggression (MERA)Experimental treatment 1 intervention
Group B: Present Centered Psychotherapy (PCT)Active comparator 1 intervention
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Michael E. DeBakey VA Medical Center
Collaborator
University of South Florida
Collaborator
VA Boston Healthcare System
Collaborator
University of Houston
Collaborator
Texas A&M University
Collaborator
Source ClinicalTrials.gov