Using Emotion Regulation to Decrease Aggression in Veterans With PTSD

NCT ID: NCT02724787

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-13
• Study Completion Date: 2018-02-07

Brief Summary

Impulsive aggression (IA) is common among Veterans with posttraumatic stress disorder (PTSD), and PTSD is one of the most prevalent post deployment mental health conditions affecting Afghanistan and Iraq Veterans. 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.

This research supports these missions by providing a 3-session emotion regulation training (Manage Emotions to Reduce Aggression) to Veterans in order to teach them how to manage emotions and prepare for PTSD treatment. This is an open trail, so all Veterans who meet the inclusion criteria will be allowed to receive the treatment. Each Veteran's level of aggression and emotion dysregulation will be measured at the beginning and end to the 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

In this pilot study for the Consortium to Alleviate PTSD, Shannon Miles, PhD, of the James A. Haley Veterans' Hospital in Tampa, Florida, and her study team will work with post-9/11 combat Veterans with PTSD and impulsive aggression. The Veterans will be identified as having impulsive aggression if they report having engaged in at least three episodes of aggression within the past month. The investigators will provide training in emotion regulation via an innovative three-session training called Managing Emotions to Reduce Aggression, or MERA.

The goal of the pilot study is to test the feasibility of MERA in reducing impulsive aggression. A secondary goal is to prepare Veterans for psychotherapy for PTSD. One reason that too few Veterans seek PTSD treatment may be that they fear that they will not be able to control their emotional responses when they begin treatment. The investigators for this study believe that equipping Veterans with emotion regulation skills and knowledge about PTSD treatments may help them initiate, complete, and benefit from evidence-based psychotherapies.

MERA is provided in a three-session, condensed time frame to make it accessible to Veterans whose careers, school, and families compete with treatment time. The training is delivered in a group format and incorporates emotion education, cognitive-behavioral and acceptance-based skills training, and information about what emotional experiences to expect from PTSD treatments. Study participants will undergo weekly assessments for emotion regulation and aggression. Following the MERA training, study participants will be followed by CAP investigators to monitor whether they seek out, receive, and complete evidence-based psychotherapies for PTSD.

Conditions

Chronic Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Trial

All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.

Group Type: OTHER

Manage Emotions to Reduce Aggression (MERA)

Intervention Type: BEHAVIORAL

MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions.

Interventions

Manage Emotions to Reduce Aggression (MERA)

MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male Veteran who served in Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND)
• Currently meets criteria for a PTSD diagnosis, determined by the Clinician-Administered PTSD Scale-5
• Engaged in at least 3 self-reported impulsive aggression acts in the last month, measured by the Overt Aggression Scale.58:

• yelling
• throwing objects
• hitting objects/people in the last month
• Impulsive aggression is his/her primary form of aggression, determined by having a higher Impulsive Aggression subscore than a Premeditated Aggression subscore on the Impulsive Premeditated Aggression Scale
• Because aggressors are poor historians when reporting their aggression frequency, each Veteran must agree to allow an independent aggression rater (live-in partner, family member, or roommate) verify the number of aggressive acts, using the Overt Aggression Scale
• No psychotropic medication change for six weeks prior to the assessment and agreement not to ask for a medication change for the duration of the study

Exclusion Criteria

Veterans who meet the following criteria will be excluded:

• Previously began Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT)
• Is currently suicidal with intent of self-harm in the last week
• Is currently homicidal with plans to hurt a specific person
• Is unable to complete self-report measures
• Does not have an independent aggression rater
• Has severe alcohol consumption patterns (Alcohol Use Disorders Identification Test), severe drug use consumption patterns (Drug Use Disorders Identification Test), active psychosis, or mania (MINI)
• Had a psychotropic medication change within 6 weeks prior to the pretraining assessment. Veterans receiving general mental health services or non- PE or CPT psychotherapy will be allowed to participate in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon R. Miles, PhD

Role: PRINCIPAL_INVESTIGATOR

James A. Haley Veterans' Hospital, Tampa, FL

Locations

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://tango.uthscsa.edu/strongstar/subs/cpinfo.asp?prj=506

Click here for more information about this study: CAP - Using Emotion Regulation to Decrease Aggression in Veterans with PTSD

Other Identifiers

W81XWH-12-PHTBI-CA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPLE-001-W14

Identifier Type: -

Identifier Source: org_study_id