Clinical trial NCT02724787: Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Official title: CAP - Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-Traumatic Stress Disorder
Keywords: Post-traumatic stress disorder
Veterans
Aggression
Emotion regulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-31
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overt Aggression Scale
timeFrame: Given 3 weeks after last MERA session. Assess aggressive events in past week.
measure: Total Score Difficulties in Emotion Regulation Scale
timeFrame: Given 3 weeks after last MERA session. Assess emotion dysregulation in past month.
measure: Emotion Regulation Questionnaire
timeFrame: Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.
measure: Exit Interview - Ratings of Therapist and Treatment
timeFrame: Given 3 weeks after last MERA session.
measure: Exit Interview - Use of Skills
timeFrame: Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Shannon R. Miles, PhD
role: PRINCIPAL_INVESTIGATOR
References: