Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients.
Hannah C Espeleta, Sara M Witcraft, Taylor Raffa...
https://pubmed.ncbi.nlm.nih.gov/39299544Actively Recruiting
Led by Medical University of South Carolina · Updated on 2025-09-04
350
Participants Needed
1
Research Sites
N/A
Total Duration
M
Medical University of South Carolina
Lead Sponsor
G
George Washington University
Collaborating Sponsor
Researchers are evaluating the Trauma Resilience and Recovery Program (TRRP) to improve mental health care access for patients after traumatic injury. This randomized controlled trial compares TRRP with enhanced usual care over 12 months to understand its impact on clinical and functional outcomes. The study also focuses on diverse patient groups, including underrepresented minorities and victims of violent trauma, to tailor the care model better. The trial is conducted at George Washington University hospital, which serves a diverse trauma patient population without an existing embedded mental health program. The TRRP is a stepped care model starting with education at the bedside about mental health recovery, risk assessment, and brief intervention for high-risk patients. It then supports symptom self-monitoring and education through automated text messages, followed by screening for PTSD and depression 30 days after injury using a chatbot or telephone. If needed, patients receive referrals and warm handoffs to mental health services. The enhanced usual care group receives education and referral information but without the stepped intervention model. Participants will be assessed at 3, 6, and 12 months after enrollment through clinical interviews and various questionnaires measuring PTSD symptoms, depression, emotional support, pain, sleep disturbance, and other health and social factors. Data from electronic medical records and demographic surveys are collected at baseline. The study includes safety and functional outcome monitoring, with qualitative interviews to identify ways to improve care for diverse patients. Total follow-up lasts one year, with detailed evaluations at multiple timepoints.
CONDITIONS
Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 months
Participants receive a stepped model of care that includes education about mental health recovery after traumatic injury, risk assessment, brief intervention for high-risk patients, symptom self-monitoring via automated text messaging, screening for PTSD and depression 30 days post-injury, and referral to mental health services if needed.
Assessments at 3, 6, and 12 months post-baseline
Total: 1 location
1
George Washington University Hospital
Washington, Virginia, United States, 20037
Actively Recruiting
G
Gabriela Becerra, BS
H
Hannah Espeleta, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hannah C Espeleta, Sara M Witcraft, Taylor Raffa...
https://pubmed.ncbi.nlm.nih.gov/39299544