Posttraumatic Stress DisorderNCT05497115
Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
A study testing Trauma Resilience and Recovery Program in people with Posttraumatic Stress Disorder and Depression, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Trauma Resilience and Recovery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 31 Mar 2027
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included.
Who cannot join
- Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
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, 1 recruiting
- Recruiting
George Washington University Hospital
Washington, Virginia, 20037
Susan Kartiko, MD/PhD, 2026776219, skartiko@mfa.gwu.edu
Susan Kartiko, MD/PhD
About this study
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
Read the detailed description
In 2015, our team launched the Trauma Resilience and Recovery Program (TRRP) at the Medical University of South Carolina's Level I trauma center. TRRP is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education via our automated text messaging system (Step 2), screen for PTSD and depression by chatbot or telephone 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4). The purpose of the proposed study is to examine the clinical and functional impact of TRRP over a period of 12 months. We will conduct a randomized controlled trial (RCT) with one-year follow up of TRRP vs. enhanced usual care (EUC) with 350 patients at The George Washington University (GWU) hospital, which serves a diverse population of ~2000 trauma center patients per year (15% penetrating mechanism). Trained, supervised interviewers blind to study condition will assess clinical and functional outcomes 3-, 6-, and 12-months post-baseline (Aim 1). Qualitative interviews will be conducted with ≥ 30 patients from underrepresented minority groups (i.e., African American, Latinx) as well as ≥ 20 victims of violent trauma (penetrating mechanism) to identify opportunities to strengthen the model to meet the diverse needs of these patients (Aim 2). GWU does not currently have an embedded mental health program in place, which will enable us to explore implementation determinants systematically (Aim 3).
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Trauma Resilience and Recovery Program
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Resilience and Recovery ProgramBehavioural
The Trauma Resilience and Recovery Program is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education (Step 2), screen for PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4).
| Study group | Role | What they receive |
|---|---|---|
| Trauma Resilience and Recovery Program | Experimental | TRRP is a stepped model of care that delivers education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), fosters symptom monitoring and continued education (Step 2), screens for PTSD and depression 30 days post-injury (Step 3), and provides a referral and warm handoff to mental health services if needed (Step 4) Receives: Behavioral: Trauma Resilience and Recovery Program |
| Enhanced Usual Care Condition | No intervention | Patients in the EUC arm will be given education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-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. The 8-item adaptation includes assessment of intrusive thoughts, avoidance of external reminders, negative expectations of self/ world, easily startled, emotional cue reactivity, avoidance of thoughts/emotions, loss of interest, and difficulty concentrating. The PCL8-5 has strong psychometric properties and clinical utility data similar to that of the long version.
Measured: Baseline, 3-, 6-, and 12- months post-baseline
Secondary outcomes (23)
Demographics
Patients will provide standard demographic information, such as race/ethnicity; sex; gender identity; immigration, insurance, marital, and socioeconomic status; language; educational attainment; and occupation
Measured: Baseline
Injured Trauma Survivor Screen (ITSS)
Injured Trauma Survivor Screen (ITSS) 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 PTSD 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
Electronic Medical Record Data (EMR)
Data will be collected at baseline via the electronic medical record including patients' length of stay; injury severity scores; number of emergency department visits; and opioid, anti-anxiety and anti-depression medications prescribed.
Measured: Baseline
The Kessler 6 (K6)
The Kessler 6 (K6) is a screening scale for nonspecific distress to discriminate cases of severe mental illness. Items are rated on a 5-point Likert scale (0-4). Total scores range from 0-24 and are calculated as the sum of all item ratings, with a total score ≥ 5 indicating moderate levels of distress and scores ≥ 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.
Measured: Baseline, 3-, 6-, and 12- months post-baseline
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionniare-9 (PHQ-9) assesses the presence and frequency of 9 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: 3-, 6-, and 12-months post- baseline assessment
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.
- Calculate a summed score across all items. All item responses scored on a scale of 1-5 where Never = 1, Always = 5
- 3. Score of a 50 is the average for US population, SD of 10
Measured: Baseline, 3-, 6-, and 12- months post-baseline
PROMIS Self-Efficacy
The 8-item PROMIS Self-Efficacy scale is a measure of confidence in one's ability to deal effectively with a variety of stressful situations.
- Calculate a summed score access all items. All item responses scored on a scale of 1-5 where Never=1, Always = 5
- Score of a 50 is the average for US population, SD of 10.
Measured: 3-, 6-, and 12-months post- baseline assessment
PROMIS Global Health
The 10-item PROMIS Global Health questionnaire measures one's overall evaluation of one's physical and mental health.
Measured: 3, 6, and 12-months post- baseline assessment
PROMIS Pain Intensity and Interference Scale
The PROMIS Pain Intensity and Interference scale assesses patients' pain and the extent to which it affects enjoyment of various activities in the past 7 days.
- Calculate a summed score access all items. All item responses scored on a scale of 1-5 where Never=1, Always = 5
- Score of a 50 is the average for US population, SD of 10.
Measured: 3-, 6-, and 12-months post- baseline assessment
PROMIS Sleep Disturbance
The 4-item PROMIS Sleep Disturbance scale assesses perceptions of sleep quality, sleep depth, and restoration associated with sleep.
- Calculate a summed score access all items. All item responses scored on a scale of 1-5.
- Score of a 50 is the average for US population, SD of 10.
Measured: 3, 6, and 12-months post- baseline assessment
National Health Interview Survey Barriers to Care
This protocol includes 5 interviewer-administered questions from the National Health Interview Survey (NHIS) Barriers to Care designed to assess when medical care was last sought, usual place of care, frequency of getting medical care and reasons for not getting medical care.
Measured: Baseline, 3-, 6-, and 12- months post-baseline
National Health Interview Survey Healthcare Utilization
This protocol includes interviewer-administered questions from the National Health Interview Survey (NHIS) Healthcare Utilization designed to assess when medical care was last sought, usual place of care, frequency of getting medical care and reasons for not getting medical care.
Measured: Baseline and 12- months post-baseline
NHIS Mental Health Care Module
6 items is designed to assess when mental health care was last sough, usual place of care, frequency of getting mental health care and reasons for not getting mental health care.
Measured: Baseline, 3-,6-, and 12-month post baseline
NHIS Job Status
Consistent with Zatzick and colleagues (2008) we will ask patients about post-injury occupational status.
Measured: Baseline, 3-,6-,and 12-month post baseline
CMH SDOH items
The Centers for Medicare \& Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) made the Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool to use in the AHC Model.1 The test is to see if systematically finding and dealing with the health-related social needs of Medicare and Medicaid beneficiaries has any effect on their total health care costs and makes their health outcomes better.
The Tool can help providers find out patients' needs in these 5 core domains that community services can help with: Housing instability, food insecurity, transportation problems, Utility help needs and interpersonal safety.
Measured: Baseline, 3-,6-,12-month post baseline
The California Health Interview Survey (CHIS) question
The California Health Interview Survey (CHIS) question allows a binary measurement of perceived prejudice, stereotyping, and discrimination in clinical encounters and experience.
Measured: Baseline, 3-, 6-, and 12- months post-baseline
Stigma Scale for Receiving Psychological Help
The Stigma Scale for Receiving Psychological Help assesses individuals' perceptions of how stigmatizing it is to receive psychological treatment. The SSRPH consists of 5 questions rated on a 4-point Likert scale.
Total Score Instructions: Total score of the 5 items. No Items are reverse scored.
Measured: 3-month post- baseline assessment
Discrimination in Medical Settings
The 7-item Discrimination in Medical Settings will measure perceived discrimination.
Measured: 3-month post baseline
Collective Efficacy (Neighborhood Environment)
The Neighborhood Environment Scale measures perceived neighborhood context and provides an estimate of cumulative exposure to adversity in childhood.
Measured: 3-months post-baseline
National Adverse Childhood Experiences Questions
The six-item standard measure from the U.S. Department of Agriculture Economic Research Service is a validated, well-established measure of the availability, accessibility, and affordability of nutritionally adequate food.
Measured: 3-months post-baseline
NIDA Quick Screen (items 2-4); 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: 3-, 6-, and 12-months post- baseline assessment
AUDIT-C
The Alcohol Use Disorders Identification Test (AUDIT-C) is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).
Measured: 3-,6-,12-month post baseline
Acceptance of Treatment Referral and Initiation of Treatment
Patients will be asked whether they considered seeking assistance for mental health needs and whether they actually sought help. These questions will be based on semi-structured interviews administered via our needs assessment that were adapted from epidemiologic interviews conducted by our team in the aftermath of the September 11, 2001 terrorist attacks and recent natural disasters. Follow-up questions will inquire about whether patients sought help from family members, friends, chaplains, mental health professionals, or other health care professionals.
Measured: 3-, 6-, and 12-months post- baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start4 Nov 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Kenneth Ruggiero, Medical University of South Carolina
- Investigators
- Kenneth Ruggiero, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497115
- Sponsor's protocol ID
- 20901
- Other IDs
- 1R01HS028006-01A1
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: First, we will analyze the qualitative and quantitative data from our interviews and randomized controlled trial and will share these data via The National Database for Clinical Trials Related to Mental Illness. We will prepare both brief and comprehensive reports for AHRQ as we have done in prior NIH studies. We also will disseminate reports of our findings via print copy to the MUSC and GWU Public Relations office and websites. Additionally, we will prepare manuscripts for submission to research journals, such as JAMA, JAMA Surgery, JAMA Psychiatry, Am J Psychiatry, J Trauma and Acute Care Surgery, J Am College of Surgeons, Am J Public Health, and other sources that ensure broad dissemination. Additionally, as we have done previously with other federally funded grants, we will seek to present our findings to AHRQ staff and at national and international conferences.
Publications
Espeleta HC, Witcraft SM, Raffa T, Kartiko S, Dawson D, Becerra G, Roisman H, Hughes-Halbert C, Mueller M, Powell E, Brock T, Sarani B, Ruggiero KJ. Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients. Contemp Clin Trials. 2024 Nov;146:107694. doi: 10.1016/j.cct.2024.107694. Epub 2024 Sep 17.
PubMed 39299544
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
- ClinicalTrials.gov ID
- NCT05497115
- Acronym / sponsor ID
- 20901
- Conditions
- Posttraumatic Stress Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- George Washington University, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Aug 2022 (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.
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
Detailed description
In 2015, our team launched the Trauma Resilience and Recovery Program (TRRP) at the Medical University of South Carolina's Level I trauma center. TRRP is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education via our automated text messaging system (Step 2), screen for PTSD and depression by chatbot or telephone 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4). The purpose of the proposed study is to examine the clinical and functional impact of TRRP over a period of 12 months. We will conduct a randomized controlled trial (RCT) with one-year follow up of TRRP vs. enhanced usual care (EUC) with 350 patients at The George Washington University (GWU) hospital, which serves a diverse population of ~2000 trauma center patients per year (15% penetrating mechanism). Trained, supervised interviewers blind to study condition will assess clinical and functional outcomes 3-, 6-, and 12-months post-baseline (Aim 1). Qualitative interviews will be conducted with ≥ 30 patients from underrepresented minority groups (i.e., African American, Latinx) as well as ≥ 20 victims of violent trauma (penetrating mechanism) to identify opportunities to strengthen the model to meet the diverse needs of these patients (Aim 2). GWU does not currently have an embedded mental health program in place, which will enable us to explore implementation determinants systematically (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Resilience and Recovery Program | Experimental | Behavioral: Trauma Resilience and Recovery ProgramTRRP is a stepped model of care that delivers education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), fosters symptom monitoring and continued education (Step 2), screens for PTSD and depression 30 days post-injury (Step 3), and provides a referral and warm handoff to mental health services if needed (Step 4) |
| Enhanced Usual Care Condition | No intervention | –Patients in the EUC arm will be given education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included.
Key exclusion criteria (1 listed)
- Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
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 |
|---|---|---|
| Trauma Resilience and Recovery ProgramThe Trauma Resilience and Recovery Program is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education (Step 2), screen for PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4). | Behavioural | Trauma Resilience and Recovery Program |
Primary outcome
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
Time frame: Baseline, 3-, 6-, and 12- months post-baseline
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. The 8-item adaptation includes assessment of intrusive thoughts, avoidance of external reminders, negative expectations of self/ world, easily startled, emotional cue reactivity, avoidance of thoughts/emotions, loss of interest, and difficulty concentrating. The PCL8-5 has strong psychometric properties and clinical utility data similar to that of the long version.
23 secondary outcomes
Demographics
Time frame: Baseline
Injured Trauma Survivor Screen (ITSS)
Time frame: Baseline
Electronic Medical Record Data (EMR)
Time frame: Baseline
The Kessler 6 (K6)
Time frame: Baseline, 3-, 6-, and 12- months post-baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3-, 6-, and 12-months post- baseline assessment
PROMIS Emotional and Instrumental Support
Time frame: Baseline, 3-, 6-, and 12- months post-baseline
PROMIS Self-Efficacy
Time frame: 3-, 6-, and 12-months post- baseline assessment
PROMIS Global Health
Time frame: 3, 6, and 12-months post- baseline assessment
PROMIS Pain Intensity and Interference Scale
Time frame: 3-, 6-, and 12-months post- baseline assessment
PROMIS Sleep Disturbance
Time frame: 3, 6, and 12-months post- baseline assessment
National Health Interview Survey Barriers to Care
Time frame: Baseline, 3-, 6-, and 12- months post-baseline
National Health Interview Survey Healthcare Utilization
Time frame: Baseline and 12- months post-baseline
NHIS Mental Health Care Module
Time frame: Baseline, 3-,6-, and 12-month post baseline
NHIS Job Status
Time frame: Baseline, 3-,6-,and 12-month post baseline
CMH SDOH items
Time frame: Baseline, 3-,6-,12-month post baseline
The California Health Interview Survey (CHIS) question
Time frame: Baseline, 3-, 6-, and 12- months post-baseline
Stigma Scale for Receiving Psychological Help
Time frame: 3-month post- baseline assessment
Discrimination in Medical Settings
Time frame: 3-month post baseline
Collective Efficacy (Neighborhood Environment)
Time frame: 3-months post-baseline
National Adverse Childhood Experiences Questions
Time frame: 3-months post-baseline
NIDA Quick Screen (items 2-4); alcohol, tobacco, prescription and illicit drug use
Time frame: 3-, 6-, and 12-months post- baseline assessment
AUDIT-C
Time frame: 3-,6-,12-month post baseline
Acceptance of Treatment Referral and Initiation of Treatment
Time frame: 3-, 6-, and 12-months post- baseline assessment
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 9 Sep 2026.
- Background: PubMed 39299544Espeleta HC, Witcraft SM, Raffa T, Kartiko S, Dawson D, Becerra G, Roisman H, Hughes-Halbert C, Mueller M, Powell E, Brock T, Sarani B, Ruggiero KJ. Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients. Contemp Clin Trials. 2024 Nov;146:107694. doi: 10.1016/j.cct.2024.107694. Epub 2024 Sep 17.
- Individual participant dataSharing planned: Yes. First, we will analyze the qualitative and quantitative data from our interviews and randomized controlled trial and will share these data via The National Database for Clinical Trials Related to Mental Illness. We will prepare both brief and comprehensive reports for AHRQ as we have done in prior NIH studies. We also will disseminate reports of our findings via print copy to the MUSC and GWU Public Relations office and websites. Additionally, we will prepare manuscripts for submission to research journals, such as JAMA, JAMA Surgery, JAMA Psychiatry, Am J Psychiatry, J Trauma and Acute Care Surgery, J Am College of Surgeons, Am J Public Health, and other sources that ensure broad dissemination. Additionally, as we have done previously with other federally funded grants, we will seek to present our findings to AHRQ staff and at national and international conferences.
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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.
Kenneth Ruggiero, 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 Trauma Resilience and Recovery Program in people with Posttraumatic Stress Disorder and Depression, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 Gabriela Becerra, BS (8439982602, becerra@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month (time frame: Baseline, 3-, 6-, and 12- months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497115, which also lists 1 linked publication.
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 9 Sep 2026.