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Behavioral Intervention
Trauma Resilience and Recovery Program for PTSD
N/A
Recruiting
Led By Kenneth Ruggiero, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-,6-,12-month post baseline
Awards & highlights
Study Summary
This trial is testing a new program to help people who have experienced trauma.
Who is the study for?
This trial is for English or Spanish speakers aged 16+ who are admitted to George Washington University's trauma center and show a risk for PTSD or depression after injury. Exclusions include severe brain injuries, cognitive impairments, psychosis, inability to communicate verbally, or serious substance abuse.Check my eligibility
What is being tested?
The study evaluates the Trauma Resilience and Recovery Program (TRRP) compared with enhanced care in patients at risk of developing PTSD or depression following traumatic injury. It aims to understand patient experiences within these programs.See study design
What are the potential side effects?
Since TRRP is a mental health intervention program rather than a medication, it may not have typical 'side effects'. However, discussing traumatic events could potentially cause emotional discomfort or temporary increases in distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-,6-,12-month post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-,6-,12-month post baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
Secondary outcome measures
AUDIT-C
Acceptance of Treatment Referral and Initiation of Treatment
CMH SDOH items
+21 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma Resilience and Recovery ProgramExperimental Treatment1 Intervention
TRRP is a stepped model of care that delivers education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), fosters symptom monitoring and continued education (Step 2), screens for PTSD and depression 30 days post-injury (Step 3), and provides a referral and warm handoff to mental health services if needed (Step 4)
Group II: Enhanced Usual Care ConditionActive Control1 Intervention
Patients in the EUC arm will be given education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,285 Total Patients Enrolled
George Washington UniversityOTHER
243 Previous Clinical Trials
453,424 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a current, serious substance abuse problem.I cannot speak due to a serious injury.I am 16 or older, speak English or Spanish, and at risk for PTSD or depression after a trauma.I am 16 or older, speak English or Spanish, and at risk for PTSD or depression after a trauma.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care Condition
- Group 2: Trauma Resilience and Recovery Program
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of individuals engaged in this clinical examination?
"Affirmative, clinicaltrials.gov indicates that this research trial is currently open for enrolment. It was initially publicized on November 4th 2022 and has since been updated as recently as the 7th of the same month. 350 volunteers are required to be sourced from a single medical centre."
Answered by AI
Are there still open enrollments for this experiment?
"This clinical investigation, which was initially advertised on November 4th 2022 and updated most recently on the 7th of that same month is still calling for applicants according to information hosted by clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
New York
Virginia
How old are they?
65+
What site did they apply to?
George Washington University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve been dealing with childhood trauma for my entire adult life. I would love to get help with it.
PatientReceived 1 prior treatment
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