An interventional study of Manage Emotions to Reduce Aggression (MERA) in Chronic Post-Traumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
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Engaged in at least 3 self-reported impulsive aggression acts in the last month, measured by the Overt Aggression Scale.58:
Exclusion Criteria:
Veterans who meet the following criteria will be excluded:
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
Behavioral: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.
| Milestone | Open Trial |
|---|---|
| Started | 24 |
| Completed | 22 |
| Not completed | 2 |
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.
| events | Open Trial |
|---|---|
| Overt Aggression Scale | 14.2 ± 11.40 |
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.
| score on a scale | Open Trial |
|---|---|
| Total Score Difficulties in Emotion Regulation Scale | 107.45 ± 19.51 |
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.
| score on a scale | Open Trial |
|---|---|
| Suppression Subscale | 16.85 ± 3.44 |
| Cognitive Reappraisal | 26.55 ± 5.83 |
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.
| score on a scale | Open Trial |
|---|---|
| How understanding therapist was | 3.94 ± 0.24 |
| How helpful therapist was | 3.68 ± 0.75 |
| How helpful MERA was | 3.15 ± 0.88 |
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.
| Participants | Open Trial |
|---|---|
| Controlled breathing | 17 |
| Remember values | 14 |
| Grounding | 14 |
| Realistic thoughts | 14 |
| Progressive muscle relaxation | 12 |
| Visualization | 12 |
| Recognizing emotions | 12 |
| Increasing positive emotions | 7 |
Collected over AE data were collected after the consent form was signed until the post-treatment assessment, an average of 10 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Trial | 0/24 (0%) | 3/24 (12.5%) | 0/24 (0%) |
| Event | Open Trial |
|---|---|
| Increase in symptomsPsychiatric disorders | 2/24 |
| HospitalizationBlood and lymphatic system disorders | 1/24 |
| Age, Continuous(years) | Open Trial |
|---|---|
| Mean | 39.17 ± 7.86 |
| Sex: Female, Male(Participants) | Open Trial |
|---|---|
| Female | 0 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | Open Trial |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Number of Overt Aggression Scale(events) | Open Trial |
|---|---|
| Mean | 30.79 ± 24.0 |
| Difficulties in Emotion Regulation(units on a scale) | Open Trial |
|---|---|
| Mean | 117.92 ± 19.1 |
| Emotion Regulation Questionnaire(units on a scale) | Open Trial |
|---|---|
| Suppression Subscale | 17.42 ± 4.75 |
| Cognitive Reappraisal Subscale | 25.42 ± 7.71 |
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