Trial Outcomes & Findings for Using Emotion Regulation to Decrease Aggression in Veterans With PTSD (NCT NCT02724787)
NCT ID: NCT02724787
Last Updated: 2019-09-17
Results Overview
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.
COMPLETED
NA
24 participants
Given 3 weeks after last MERA session. Assess aggressive events in past week.
2019-09-17
Participant Flow
Participant milestones
| Measure |
Open Trial
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Open Trial
n=24 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Age, Continuous
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39.17 years
STANDARD_DEVIATION 7.86 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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24 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Number of Overt Aggression Scale
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30.79 events
STANDARD_DEVIATION 24.0 • n=5 Participants
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Difficulties in Emotion Regulation
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117.92 units on a scale
STANDARD_DEVIATION 19.1 • n=5 Participants
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Emotion Regulation Questionnaire
Suppression Subscale
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17.42 units on a scale
STANDARD_DEVIATION 4.75 • n=5 Participants
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Emotion Regulation Questionnaire
Cognitive Reappraisal Subscale
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25.42 units on a scale
STANDARD_DEVIATION 7.71 • n=5 Participants
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PRIMARY outcome
Timeframe: Given 3 weeks after last MERA session. Assess aggressive events in past week.Population: 22 participants completed the treatment. 20 participants returned for the post-treatment assessment.
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.
Outcome measures
| Measure |
Open Trial
n=20 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Overt Aggression Scale
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14.2 events
Standard Deviation 11.40
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PRIMARY outcome
Timeframe: Given 3 weeks after last MERA session. Assess emotion dysregulation in past month.Population: 22 participants completed the treatment. 20 participants returned for the post-treatment assessment.
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.
Outcome measures
| Measure |
Open Trial
n=20 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Total Score Difficulties in Emotion Regulation Scale
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107.45 score on a scale
Standard Deviation 19.51
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PRIMARY outcome
Timeframe: Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.Population: 22 participants completed the treatment. 20 participants returned for the post-treatment assessment.
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.
Outcome measures
| Measure |
Open Trial
n=20 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Emotion Regulation Questionnaire
Suppression Subscale
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16.85 score on a scale
Standard Deviation 3.44
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Emotion Regulation Questionnaire
Cognitive Reappraisal
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26.55 score on a scale
Standard Deviation 5.83
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PRIMARY outcome
Timeframe: Given 3 weeks after last MERA session.Population: 22 participants completed the treatment. 20 participants returned for the post-treatment assessment.
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.
Outcome measures
| Measure |
Open Trial
n=20 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Exit Interview - Ratings of Therapist and Treatment
How understanding therapist was
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3.94 score on a scale
Standard Deviation 0.24
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Exit Interview - Ratings of Therapist and Treatment
How helpful therapist was
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3.68 score on a scale
Standard Deviation 0.75
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Exit Interview - Ratings of Therapist and Treatment
How helpful MERA was
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3.15 score on a scale
Standard Deviation 0.88
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PRIMARY outcome
Timeframe: Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.Population: 22 participants completed the treatment. 20 participants returned for the post-treatment assessment.
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.
Outcome measures
| Measure |
Open Trial
n=20 Participants
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Exit Interview - Use of Skills
Controlled breathing
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17 Participants
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Exit Interview - Use of Skills
Remember values
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14 Participants
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Exit Interview - Use of Skills
Grounding
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14 Participants
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Exit Interview - Use of Skills
Realistic thoughts
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14 Participants
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Exit Interview - Use of Skills
Progressive muscle relaxation
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12 Participants
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Exit Interview - Use of Skills
Visualization
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12 Participants
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Exit Interview - Use of Skills
Recognizing emotions
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12 Participants
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Exit Interview - Use of Skills
Increasing positive emotions
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7 Participants
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Adverse Events
Open Trial
Serious adverse events
| Measure |
Open Trial
n=24 participants at risk
All Veterans will receive the same emotion regulation treatment titled, Manage Emotions to Reduce Aggression.
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.
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Blood and lymphatic system disorders
Hospitalization
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4.2%
1/24 • AE data were collected after the consent form was signed until the post-treatment assessment, an average of 10 weeks.
We considered any clinically significant deterioration in physical, psychological, mental, cognitive, or psychosocial health status of the subject as a change from baseline as an AE. We did not use specific Adverse Event Terms.
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Psychiatric disorders
Increase in symptoms
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8.3%
2/24 • AE data were collected after the consent form was signed until the post-treatment assessment, an average of 10 weeks.
We considered any clinically significant deterioration in physical, psychological, mental, cognitive, or psychosocial health status of the subject as a change from baseline as an AE. We did not use specific Adverse Event Terms.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place