CHW-Enhanced Trauma Recovery

NCT07818161 | Not Yet Recruiting DMC

• 2 other identifiers: Pro001523411R21MD021589-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury; Posttraumatic Stress Disorder; Social Determinants of Health; Depression

Outcome Measures

Primary Outcomes (11)

• Demographics

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

  Baseline

• The Kessler 6 (K6)

  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.

  Baseline, 1 month and 3 months

• Injured Trauma Survivor Screen (ITSS)

  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.

  Baseline

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

  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.

  Baseline and 3 month

• PTSD Checklist for DSM-5 (PCL-5)

  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.

  One month and 3 month

• Patient Health Questionnaire (PHQ-8)

  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.

  one month and 3 month

• PROMIS General Life Satisfaction

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

  Baseline, one month, and 3 month

• Service Engagement Scale

  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.

  One month and three month

• Intervention Acceptability

  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).

  3 month

• Intervention Appropriateness

  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)

  3 month

• Intervention Feasibility

  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).

  3 month

Secondary Outcomes (3)

• 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

Study Arms (1)

TRRP+

EXPERIMENTAL

Behavioral: CHW support

Interventions

CHW support BEHAVIORAL

CHW support to address unmet SDOH needs.

TRRP+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• Able and willing to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Theresa Skojec, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah German

CONTACT

8437920979; germansa@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (1)