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Present Centered Psychotherapy for PTSD (MERA Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment group differences in ebp initiation at 6 months posttreatment.
Awards & highlights
MERA Trial 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.
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.
MERA Trial 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.
Select...
I agree not to change my mental health medications during the study.
Select...
I have been diagnosed with PTSD or show symptoms of it.
Select...
I am a veteran who served in a combat zone after 9/11.
MERA Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Overt Aggression Scale (OAS)
Secondary outcome measures
Change in Difficulties in Emotion Regulation Scale (DERS)
Other outcome measures
Evidence Based Psychotherapy (EBP) Initiation
MERA 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
Who is running the clinical trial?
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,248 Total Patients Enrolled
University of HoustonOTHER
147 Previous Clinical Trials
47,274 Total Patients Enrolled
Texas A&M UniversityOTHER
140 Previous Clinical Trials
23,902 Total Patients Enrolled
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.
Emotion Regulation Patient Testimony for trial: Trial Name: NCT04793776 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research only include young adults, or are older patients being accepted as well?
"This study's eligibility requirements include being between 18-64 years old."
Answered by AI
Could I take part in this experimental medication program?
"The eligibility requirements for this study are that potential patients must have some ability to regulate their emotions and be between 18-64 years old. A total of 204 individuals will be enrolled in the trial."
Answered by AI
Are there any vacancies in this clinical trial for new test subjects?
"Yes, as of 1/10/2022 this clinical trial is seeking participants. The study was originally posted on 1/3/2022 and will be conducted at 2 sites with a total of 204 patients."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
James A. Haley Veterans' Hospital, Tampa, FL
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I need something to help me with my moods and outbursts! I become agitated very quickly.
PatientReceived 2+ prior treatments
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