Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT07818161
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 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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Traumatic injuries are associated with substantial risk for posttraumatic stress disorder, 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. 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 MUSC Level I Adult Trauma Center following traumatic injury who screen positive for risk of PTSD or depression on the Injured Trauma Survivor Screen and report at least one unmet social need on the Accountable Health Communities 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 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CHW support to address unmet SDOH needs.
Time frame: Baseline
Patients will provide standard demographic information, such as race/ethnicity; sex; insurance, marital, and socioeconomic status; educational attainment; and occupation.
Time frame: Baseline, 1 month and 3 months
The Kessler 6 (K6; Kessler et al., 2003) 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.
Time frame: Baseline
Injured Trauma Survivor Screen (ITSS; Hunt et al., 2018; 2018) 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.
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 (Billioux et al., 2017) across clinical settings and populations, supporting its widespread use for screening and referral within healthcare systems.
Time frame: One month and 3 month
The PTSD Checklist for DSM-5 (Weathers et al., 2013) 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.
Time frame: one month and 3 month
The Patient Health Questionnaire-8 (PHQ-8; Kroenke, Spitzer, & Williams, 2001) 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.
Time frame: Baseline, one month, and 3 month
The 10-item PROMIS General Life Satisfaction questionnaire (Salsman et al., 2014) measures one's perception of life experiences and whether one likes his/her life or not.
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 (Tait et al., 2002), including high internal consistency (α ≈ .85-.90), good test-retest reliability, and established construct validity across clinical populations.
Time frame: 3 month
A 4-item validated measure assessing the perceived acceptability of an intervention among those delivering or receiving it (Weiner et al., 2017). Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91).
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)
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).
Time frame: Baseline, one month, and three month
The PROMIS Emotion and Instrumental Support (Hahn et al.,2014) 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.
Time frame: Baseline, one month, and three month
This protocol includes 10 interviewer-administered questions from the National Health Interview Survey (NHIS) Adult Access to Health Care & Utilization Module (CDC, 2019) designed to assess when medical care was last sought, usual place of care, frequency of getting care and reasons for not getting care.
Time frame: Baseline, one month, and three month
The NIDA Quick Screen (NIDA, 2010) 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
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
Improving Engagement in Post-Injury Mental Health Care Through Community Health Worker-Enhanced Trauma Recovery Services
Acronym: TRRP+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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