Traumatic InjuryTRRP+NCT07818161
CHW-Enhanced Trauma Recovery
A study testing CHW support in people with Traumatic Injury and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Injury, Posttraumatic Stress Disorder, Depression
- What is being tested?
- CHW support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Sarah German, 8437920979, germansa@musc.edu
About this study
Official title: Improving Engagement in Post-Injury Mental Health Care Through Community Health Worker-Enhanced Trauma Recovery Services
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.
Read the 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.
- Conditions
- Traumatic Injury, Posttraumatic Stress Disorder, Depression, Social Determinants of Health
- Being tested
- CHW support
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW supportBehavioural
CHW support to address unmet SDOH needs.
| Study group | Role | What they receive |
|---|---|---|
| TRRP+ | Experimental | Not described Receives: Behavioral: CHW support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Patients will provide standard demographic information, such as race/ethnicity; sex; insurance, marital, and socioeconomic status; educational attainment; and occupation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 3 month
Secondary outcomes (3)
PROMIS Emotional and Instrumental Support
The PROMIS Emotion and Instrumental Support measure assesses perceived feelings of being cared for and valued as a person; having confidant relationships and availability of assistance with material, cognitive or task performance.
Measured: Baseline, one month, and three month
National Health Interview Survey Adult Access to Health Care and Utilization Module
This protocol includes 10 interviewer-administered questions from the National Health Interview Survey (NHIS) Adult Access to Health Care \& Utilization Module designed to assess when medical care was last sought, usual place of care, frequency of getting care and reasons for not getting care.
Measured: Baseline, one month, and three month
NIDA Quick Screen; alcohol, tobacco, prescription and illicit drug use
The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used
Measured: Baseline, one month, and three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Theresa Skojec, Medical University of South Carolina
- Investigators
- Theresa Skojec, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818161
- Sponsor's protocol ID
- Pro00152341
- Other IDs
- 1R21MD021589-01
- Acronym
- TRRP+
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Engagement in Post-Injury Mental Health Care Through Community Health Worker-Enhanced Trauma Recovery Services
- ClinicalTrials.gov ID
- NCT07818161
- Acronym / sponsor ID
- TRRP+ / Pro00152341
- Conditions
- Traumatic Injury, Posttraumatic Stress Disorder, Depression, Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRRP+ | Experimental | Behavioral: CHW support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW supportCHW support to address unmet SDOH needs. | Behavioural | TRRP+ |
Primary outcome
Demographics
Time frame: Baseline
Patients will provide standard demographic information, such as race/ethnicity; sex; insurance, marital, and socioeconomic status; educational attainment; and occupation.
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).
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).
3 secondary outcomes
PROMIS Emotional and Instrumental Support
Time frame: Baseline, one month, and three month
National Health Interview Survey Adult Access to Health Care and Utilization Module
Time frame: Baseline, one month, and three month
NIDA Quick Screen; alcohol, tobacco, prescription and illicit drug use
Time frame: Baseline, one month, and three month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Traumatic Injury
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theresa Skojec, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW support in people with Traumatic Injury and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah German (8437920979, germansa@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.