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Present Centered Psychotherapy for PTSD (MERA Trial)
Houston, TX
N/A
Recruiting
Led By Shannon R. Miles, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agreement not to change psychotropic medications through the duration of the study.
Agreement not to change psychotropic medications through the duration of the study
Must not have
Meets diagnostic criteria for bipolar disorder or psychotic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment group differences in ebp initiation at 6 months posttreatment.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a 3-session emotion regulation treatment can help veterans with PTSD reduce impulsive aggression and better prepare for PTSD treatment.
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Who is the study for?
This trial is for Veterans who served since 9/11, have PTSD or subthreshold PTSD, and show impulsive aggression. They must not change their psychotropic medications during the study and need an independent observer to verify aggressive acts.Check my eligibility
What is being tested?
The MERA trial compares a new 3-session emotion regulation treatment with a control group to see if it can reduce impulsive aggression in Veterans and prepare them for PTSD treatment.See study design
What are the potential side effects?
Since this is a psychotherapy intervention, typical side effects associated with medications are not expected. However, participants may experience emotional discomfort when discussing traumatic experiences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to change my mental health medications during the study.
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I agree not to change my mental health medications during the study.
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Select...
I have been diagnosed with PTSD or show symptoms of it.
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Select...
I am a veteran who served in a combat zone after 9/11.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with bipolar disorder or a psychotic disorder.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment group differences in ebp initiation at 6 months posttreatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment group differences in ebp initiation at 6 months posttreatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Overt Aggression Scale (OAS)
Secondary study objectives
Change in Difficulties in Emotion Regulation Scale (DERS)
Other study objectives
Evidence Based Psychotherapy (EBP) Initiation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Manage Emotions to Reduce Aggression (MERA)Experimental Treatment1 Intervention
MERA is 3 individual 90-minute sessions delivered over 3 weeks.
Group II: Present Centered Psychotherapy (PCT)Active Control1 Intervention
PCT delivered in 3 individual 90-minute sessions over 3 weeks.
Find a Location
Closest Location:Michael E. DeBakey VA Medical Center, Houston, TX· Houston, TX· 574 miles
Who is running the clinical trial?
VA Boston Healthcare SystemFED
72 Previous Clinical Trials
970,711 Total Patients Enrolled
University of HoustonOTHER
154 Previous Clinical Trials
48,401 Total Patients Enrolled
1 Trials studying Aggression
50 Patients Enrolled for Aggression
Texas A&M UniversityOTHER
154 Previous Clinical Trials
28,776 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,686 Previous Clinical Trials
3,758,430 Total Patients Enrolled
6 Trials studying Aggression
890 Patients Enrolled for Aggression
University of South FloridaOTHER
430 Previous Clinical Trials
197,536 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
67 Previous Clinical Trials
17,025 Total Patients Enrolled
2 Trials studying Aggression
52 Patients Enrolled for Aggression
Shannon R. Miles, PhDPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Aggression
24 Patients Enrolled for Aggression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to change my mental health medications during the study.I am a veteran who served in a combat zone after 9/11.I have someone over 18 who can report on my aggressive behaviors.I have been diagnosed with bipolar disorder or a psychotic disorder.I agree not to change my mental health medications during the study.I have been diagnosed with PTSD or show symptoms of it.I haven't changed my mental health medication in the last 4 weeks.I am a veteran who served in a combat zone after 9/11.
Research Study Groups:
This trial has the following groups:- Group 1: Present Centered Psychotherapy (PCT)
- Group 2: Manage Emotions to Reduce Aggression (MERA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aggression Patient Testimony for trial: Trial Name: NCT04793776 — N/A