Trauma Resilience and Recovery Program for PTSD

Overseen By Susan Kartiko, MD/PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Cognitive impairment, Active psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how patients experience a program designed to aid recovery from trauma and build resilience. The Trauma Resilience and Recovery Program offers education, risk assessment, and mental health support for individuals recovering from traumatic injuries. Participants divide into two groups: one receives enhanced usual care with educational materials, while the other benefits from a more intensive program that includes ongoing support and mental health referrals if needed. Ideal candidates for this trial have recently been admitted to a trauma center, speak English or Spanish, and are at risk for PTSD or depression following their injury. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve trauma recovery programs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Trauma Resilience and Recovery Program is safe for PTSD patients?

Research has shown that the Trauma Resilience and Recovery Program (TRRP) is well-received in trauma centers, indicating its safety for individuals who have experienced traumatic injuries. Studies reveal that many patients participate actively without major issues.

The TRRP includes several steps. It begins with educating patients about mental health recovery at their bedside. For those at higher risk, a short intervention is provided. Patients' symptoms are closely monitored, and they receive ongoing education. If necessary, referrals to mental health services are made.

No reports of serious side effects from the TRRP exist. The program aims to manage symptoms of PTSD (post-traumatic stress disorder) and depression early on. Its goal is to support mental health recovery after trauma. This program is generally safe because it focuses on education and support, not medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Trauma Resilience and Recovery Program (TRRP) is unique because it offers a comprehensive, stepped approach to mental health recovery after a traumatic injury. Unlike standard treatments that often focus solely on therapy or medication, TRRP combines bedside education, risk assessment, and brief intervention right after the injury. It continues with symptom monitoring and education, followed by PTSD and depression screening 30 days later, and ensures a warm handoff to mental health services if necessary. This holistic and proactive approach aims to address mental health needs early and thoroughly, which is why researchers are excited about its potential to improve recovery outcomes.

What evidence suggests that the Trauma Resilience and Recovery Program could be effective for PTSD?

Research has shown that the Trauma Resilience and Recovery Program (TRRP), which participants in this trial may receive, can aid individuals after traumatic injuries. This program effectively engages patients in their care within trauma centers. It includes mental health education, risk assessments, and referrals for PTSD (post-traumatic stress disorder) and depression. Studies suggest that TRRP might reduce PTSD and depression symptoms by providing ongoing support and monitoring. Overall, the program aims to enhance mental health recovery by connecting patients to necessary care. Meanwhile, participants in the Enhanced Usual Care Condition arm will receive mental health education after traumatic injury, educational materials on mental health recovery, and local referral information to assist in seeking treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Kenneth Ruggiero, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Patients who have a Glasgow Coma Scale score under 13 at hospital admission

Patients with moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment)

I do not have a current, serious substance abuse problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive education at the bedside about mental health recovery after traumatic injury, risk assessment, and brief intervention for high-risk patients

1-2 weeks

In-person at the trauma center

Symptom Monitoring and Education

Participants engage in symptom self-monitoring and continued education via an automated text messaging system

4 weeks

PTSD and Depression Screening

Screening for PTSD and depression by chatbot or telephone 30 days post-injury

1 week

Virtual

Referral and Handoff

Referral and warm handoff to mental health services if needed

Ongoing as needed

Follow-up

Participants are monitored for clinical and functional outcomes at 3-, 6-, and 12-months post-baseline

12 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Trauma Resilience and Recovery Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Trauma Resilience and Recovery Program Experimental Treatment 1 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 Condition Active Control 1 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The Trauma Resiliency Model (TRM) is a unique therapy for trauma that focuses on body awareness and emotion regulation through nine specific skills, suggesting it may be more effective than traditional cognitive therapies.

While research on somatic therapies like TRM is limited, the approach is supported by neuroscience, indicating that understanding trauma responses biologically can help individuals process trauma more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trauma Resiliency Model: A "Bottom-Up" Intervention for Trauma Psychotherapy. Grabbe, L., Miller-Karas, E.[2019]

In a study involving 116 PTSD patients, both Brief Eclectic Psychotherapy (BEP) and Eye Movement Desensitization and Reprocessing (EMDR) therapy led to significant increases in posttraumatic growth, indicating that these therapies not only help reduce PTSD symptoms but also promote positive personal development.

The research found that greater reductions in PTSD symptoms were associated with greater increases in posttraumatic growth, suggesting a relationship between symptom improvement and personal growth, although no specific treatment was found to predict these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning wounds into wisdom: Posttraumatic growth over the course of two types of trauma-focused psychotherapy in patients with PTSD. Nijdam, MJ., van der Meer, CAI., van Zuiden, M., et al.[2018]

The Trauma Resilience and Recovery Program (TRRP) successfully engaged 96% of families approached, providing a structured approach to address the mental health needs of pediatric patients after hospitalization for injuries, with a focus on PTSD and depression.

Among families enrolled, 35.5% reported clinically significant PTSD and/or depression symptoms, and 76% of those with significant symptoms agreed to receive treatment, indicating the program's effectiveness in identifying and addressing mental health issues post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma Resilience and Recovery Program: Addressing Mental Health in Pediatric Trauma Centers. Ridings, LE., Anton, MT., Winkelmann, J., et al.[2022]

In a Level II trauma center, 86% of adult trauma patients enrolled in the Trauma Resilience and Recovery Program (TRRP), indicating strong initial engagement despite fewer resources compared to Level I centers.

However, only 30% of patients completed mental health screenings during follow-up, suggesting a need for program adaptations to enhance ongoing engagement and address mental health needs more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a stepped care program to address posttraumatic stress disorder and depression in a Level II trauma center. Espeleta, HC., Litvitskiy, NS., Higgins, K., et al.[2023]

In a study of 172 patients with PTSD at a trauma center, those with private insurance, a high school diploma or higher, and more severe PTSD symptoms were more likely to participate in Trauma Recovery Services (TRS) programming, which aims to reduce PTSD symptoms and improve patient satisfaction.

Patients living further away from the TRS location were less likely to participate, suggesting that reducing travel distance could enhance participation in psychosocial programs for PTSD recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing participation in psychosocial programming among orthopaedic trauma patients with PTSD. Furdock, RJ., Feldman, B., Sinkler, M., et al.[2022]

The PTSD Recovery Program, which includes group therapy alongside individual therapy and medication, was effectively used to treat PTSD in 18 refugees over 10 weekly sessions, showing positive outcomes based on pre- and post-intervention questionnaires.

Qualitative data from participants indicated symptom improvement, and providers reported high satisfaction with the program, supporting its efficacy as an adjunctive treatment for PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Veterans Affairs Posttraumatic Stress Disorder Group Therapy Program With Refugees. Haefner, J., Abedi, M., Morgan, S., et al.[2019]

The Trauma Recovery Project study, involving 1,048 trauma patients, found that functional limitations persisted significantly at 12 and 18 months post-injury, with mean Quality of Well-Being scores remaining below the healthy norm, indicating a long-term impact on quality of life after major trauma.

Factors such as postinjury depression, PTSD, serious extremity injuries, and the number of days spent in the intensive care unit were identified as significant predictors of poor functional outcomes, highlighting the need for comprehensive post-trauma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome after major trauma: 12-month and 18-month follow-up results from the Trauma Recovery Project. Holbrook, TL., Anderson, JP., Sieber, WJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914157/

Implementation of a Stepped Care Program to Address ... This report describes our application of the Exploration, Preparation, Implementation, Sustainment model to implement the Trauma Resilience and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05497115

Testing a Scalable Model of Care to Improve Patients ... The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138323006083

Implementation of a stepped care program to address ... TRRP is a technology enhanced model of care that includes education, screening, and service referrals to address posttraumatic stress disorder and depression.

4. withpower.com withpower.com/trial/phase-post-traumatic-stress-disorder-ptsd-8-2022-54f27

Trauma Resilience and Recovery Program for PTSD The Trauma Resilience and Recovery Program (TRRP) has shown high engagement rates in trauma centers, indicating its potential effectiveness in addressing PTSD ...

5. muschealth.org muschealth.org/health-professionals/progressnotes/2022/fall/mental-health-following-severe-injury

Program at MUSC addresses mental health following ... Trauma Resilience and Recovery Program helps curb PTSD and depression after traumatic injury.

6. muschealth.org muschealth.org/medical-services/emergency/trauma/telehealth-resiliance-and-recovery-program

Telehealth Resilience & Recovery Program (TRRP) Our goal is to accelerate mental health recovery by identifying and treating symptoms of depression and posttraumatic stress disorder early in the recovery ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528678/

Implementation of a Stepped Care Program to Address ... The Trauma Resilience and Recovery Program (TRRP) is a technology enhanced model of care that includes education, screening, ...