Using Emotion Regulation to Decrease Aggression in Veterans With PTSD

NCT02724787 | Completed Results

• 2 other identifiers: SPLE-001-W14W81XWH-12-PHTBI-CA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post-Traumatic Stress Disorder

Keywords

Post-traumatic stress disorder; Veterans; Aggression; Emotion regulation

Outcome Measures

Primary Outcomes (5)

• Overt Aggression Scale

  The Overt Aggression Scale (OAS) is a 17-item self-report measure that assesses frequency of different aggression acts, including verbal and physical aggression against self, other, and objects. Theoretical minimum score = 0; there is no bounded maximum value. Higher values = greater frequency of aggression.

  Given 3 weeks after last MERA session. Assess aggressive events in past week.

• Total Score Difficulties in Emotion Regulation Scale

  The Difficulties in Emotion Regulation Scale (DERS) 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. Total score was used in this study. Theoretical minimum value = 36; theoretical maximum value = 180. Higher scores indicate worse emotion regulation.

  Given 3 weeks after last MERA session. Assess emotion dysregulation in past month.

• Emotion Regulation Questionnaire

  ERQ is a 10-item self-report measure with 2 factors that assess specific emotion regulation strategies: cognitive reappraisal (6 items; changing the way one thinks about a situation) and expressive suppression (4 items; not expressing the emotion outwardly but feeling it internally). More effective emotion regulation is indicated by higher cognitive reappraisal scores and lower expressive suppression scores. Theoretical minimum score for cognitive reappraisal = 6; theoretical maximum score = 42. Theoretical minimum score for expressive suppression = 4; theoretical maximum score = 28.

  Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.

• Exit Interview - Ratings of Therapist and Treatment

  The exit interview was created by the study team and has 3 questions that asks: 1.) how understanding the therapist was, 2.) how helpful the therapist was in learning skills, and 3.) how helpful MERA was in managing emotions. Scale for all questions: * 1 = Not at all understanding / helpful * 2 = A little bit understanding / helpful * 3 = Moderately understanding / helpful * 4 = Very understanding / helpful Higher scores reflect greater understanding or helpfulness.

  Given 3 weeks after last MERA session.

• Exit Interview - Use of Skills

  The exit interview was created by the study team and has 8 questions that asks: 1.) "Are you using \_\_\_\_\_skill?". Scores = percentage of the sample that was using the skill during the week before the post treatment assessment. Percentages could range from 0% to 100% of the sample. Higher scores represent more of the sample using the skill.

  Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.

Study Arms (1)

Open Trial

OTHER

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

Behavioral: Manage Emotions to Reduce Aggression (MERA)

Interventions

Manage Emotions to Reduce Aggression (MERA) 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.

Open Trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Links

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Aggression; Emotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Self-Control

Results Point of Contact

• Title: Dr. Shannon Miles
• Organization: James A. Haley Veterans' Hospital

shannon.miles@va.gov

813-972-2000

Study Officials

• Shannon R. Miles, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 31, 2016
• Study Start: June 13, 2016
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: September 17, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)