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Clinical Trials/NCT07818161
NCT07818161Not yet recruitingNot Applicable

Improving Engagement in Post-Injury Mental Health Care Through Community Health Worker-Enhanced Trauma Recovery Services

Medical University of South Carolina1 site in 1 country100 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
Demographics

Study Overview

Brief Summary

This pilot study will evaluate the feasibility, acceptability, and preliminary effectiveness of the Trauma Resilience and Recovery Program Plus (TRRP+), a Community Health Worker-enhanced intervention designed to improve behavioral health engagement and recovery among adult trauma survivors with unmet social needs. One hundred adult trauma patients admitted to the Medical University of South Carolina (MUSC) Level I Adult Trauma Center who screen positive for risk of posttraumatic stress disorder (PTSD) or depression and report at least one unmet social need will receive TRRP+ services. Participants will complete assessments at baseline, 1 month, and 3 months after enrollment. The study will also examine implementation barriers and facilitators to support future dissemination and scale-up of the intervention.

Detailed Description

Traumatic injuries are associated with substantial risk for posttraumatic stress disorder (PTSD), depression, reduced quality of life, and poor recovery, particularly among survivors with unmet social determinants of health such as housing, food, financial, or transportation insecurity. The Trauma Resilience and Recovery Program (TRRP) is an evidence-based stepped-care model that includes in-hospital behavioral health education and screening, post-discharge symptom monitoring, 30-day follow-up screening, and referral to behavioral health treatment when indicated. Trauma Resilience and Recovery Program Plus (TRRP+) enhances this model by integrating Community Health Worker (CHW)-delivered assessment, care planning, resource navigation, and follow-up support to address unmet social needs that may interfere with behavioral health engagement.

Aim 1 will assess the feasibility, acceptability, and preliminary impact of TRRP+ in an open-label, single-arm pilot trial with 100 adult trauma survivors. Eligible participants will be adults admitted to the Medical University of South Carolina (MUSC) Level I Adult Trauma Center following traumatic injury who screen positive for risk of PTSD or depression on the Injured Trauma Survivor Screen (ITSS) and report at least one unmet social need on the Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool. Participants will receive TRRP+ and complete baseline, 1-month, and 3-month assessments of behavioral health service engagement, PTSD symptoms, depression symptoms, quality of life, social needs, substance use, and implementation outcomes.

Aim 2 will use qualitative interviews and implementation evaluation activities guided by the Consolidated Framework for Implementation Research (CFIR) to identify barriers, facilitators, contextual factors, and implementation determinants that may affect adoption, scalability, and sustainability of TRRP+ within trauma care settings. Findings will inform refinement of the intervention and the design of a future multi-site hybrid effectiveness-implementation trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adults 18 years of age or older.
  • •Admitted to the Medical University of South Carolina (MUSC) Adult Trauma Service following a traumatic injury.
  • •English-speaking.
  • •Screen positive for risk of posttraumatic stress disorder (PTSD) and/or depression on the Injured Trauma Survivor Screen (ITSS), defined as a score greater than 2 on either subscale.
  • •Report at least one unmet social need on the Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool, defined as a score greater than or equal to
  • •Able and willing to provide informed consent.

Exclusion Criteria

  • •Glasgow Coma Scale (GCS) score less than 13 at hospital admission.
  • •Moderate to severe cognitive impairment that precludes informed consent or study participation.
  • •Active psychosis.
  • •Injury that prevents verbal communication, such as severe traumatic brain injury or spinal cord injury.
  • •Self-inflicted injury.
  • •Currently incarcerated.
  • •Unable to speak or understand English.

Arms & Interventions

TRRP+

Experimental

Intervention: CHW support (Behavioral)

Outcomes

Primary Outcomes

Demographics

Time Frame: Baseline

Patients will provide standard demographic information, such as race/ethnicity; sex; insurance, marital, and socioeconomic status; educational attainment; and occupation.

Intervention Appropriateness

Time Frame: 3 month

A 4-item validated measure assessing the perceived fit, relevance, and suitability of an intervention for a particular setting or population. Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91)

Intervention Feasibility

Time Frame: 3 month

A 4-item validated measure assessing the extent to which an intervention is perceived as practical and implementable within a given setting. Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91).

The Kessler 6 (K6)

Time Frame: Baseline, 1 month and 3 months

The Kessler 6 is a screening scale for nonspecific distress to discriminate cases of several mental illness. Items are rated on a 5-point Likert scale (1-5). Total scores range from 6-30 and are calculated as the sum of all item ratings, with a total score 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.

Injured Trauma Survivor Screen (ITSS)

Time Frame: Baseline

Injured Trauma Survivor Screen is a 9-item measure used to assess risk for development of posttraumatic stress symptoms following injury. Items are rated yes=1 and no=0. If the sum of questions 1, 2, 3, 5, and 6 is equal to or greater than 2, the screen is positive for PTS risk. If the sum of questions 3, 4, 7, 8, and 9 is equal or greater than 2, the screen is positive for depression risk.

Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool

Time Frame: Baseline and 3 month

The AHC is a standardized 10-item instrument developed by the Centers for Medicare \& Medicaid Services (CMS) to identify individuals' social needs across five key domains: housing instability, food insecurity, transportation, utility needs, and interpersonal safety. The tool has demonstrated strong feasibility, reliability, and content validity across clinical settings and populations, supporting its widespread use for screening and referral within healthcare systems.

PTSD Checklist for DSM-5 (PCL-5)

Time Frame: One month and 3 month

The PTSD Checklist for DSM-5 is a self-report measure that assesses the extent to which participants are bothered by the DSM-5 PTSD symptoms. Each symptom is rated on a scale of 0 (not at all) to 4 (extremely). Total scores are obtained by summing the scores of all items.

Patient Health Questionnaire (PHQ-8)

Time Frame: one month and 3 month

The Patient Health Questionnaire-8 assesses the presence and frequency of 8 core depressive symptoms. Items are rated on a 4-point Likert scale (0-3). Total scores range from 0-27 and are calculated as the sum of all item ratings, with a total score of ≥ 10 indicating clinical significance.

PROMIS General Life Satisfaction

Time Frame: Baseline, one month, and 3 month

The 10-item PROMIS General Life Satisfaction questionnaire measures one's perception of life experiences and whether one likes his/her life or not.

Service Engagement Scale

Time Frame: One month and three month

The 14-item measure that assesses the extent of a patient's engagement with mental health services across domains such as availability, collaboration, help-seeking, and medication adherence. The SES demonstrates strong psychometric properties, including high internal consistency (α ≈ .85-.90), good test-retest reliability, and established construct validity across clinical populations.

Intervention Acceptability

Time Frame: 3 month

A 4-item validated measure assessing the perceived acceptability of an intervention among those delivering or receiving it. Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91).

Secondary Outcomes

  • PROMIS Emotional and Instrumental Support(Baseline, one month, and three month)
  • National Health Interview Survey Adult Access to Health Care and Utilization Module(Baseline, one month, and three month)
  • NIDA Quick Screen; alcohol, tobacco, prescription and illicit drug use(Baseline, one month, and three month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Theresa Skojec

Assistant Professor-Faculty

Medical University of South Carolina

Study Sites (1)

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