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Using Emotion Regulation to Decrease Aggression in Veterans With PTSD ((EMDA))

Primary Purpose

Chronic Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manage Emotions to Reduce Aggression (MERA)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Post-Traumatic Stress Disorder focused on measuring Post-traumatic stress disorder, Veterans, Aggression, Emotion regulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Trial

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2016
Last Updated
September 6, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02724787
Brief Title
Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Acronym
(EMDA)
Official Title
CAP - Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-Traumatic Stress Disorder
Keywords
Post-traumatic stress disorder, Veterans, Aggression, Emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Trial
Arm Type
Other
Arm Description
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
Intervention Type
Behavioral
Intervention Name(s)
Manage Emotions to Reduce Aggression (MERA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overt Aggression Scale
Description
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.
Time Frame
Given 3 weeks after last MERA session. Assess aggressive events in past week.
Title
Total Score Difficulties in Emotion Regulation Scale
Description
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.
Time Frame
Given 3 weeks after last MERA session. Assess emotion dysregulation in past month.
Title
Emotion Regulation Questionnaire
Description
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.
Time Frame
Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.
Title
Exit Interview - Ratings of Therapist and Treatment
Description
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.
Time Frame
Given 3 weeks after last MERA session.
Title
Exit Interview - Use of Skills
Description
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.
Time Frame
Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon R. Miles, PhD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://tango.uthscsa.edu/strongstar/subs/cpinfo.asp?prj=506
Description
Click here for more information about this study: CAP - Using Emotion Regulation to Decrease Aggression in Veterans with PTSD

Learn more about this trial

Using Emotion Regulation to Decrease Aggression in Veterans With PTSD

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