Post-Traumatic Stress Disorder (PTSD)NCT07829510
Transforming Trauma Care
A study testing Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) in people with Post-Traumatic Stress Disorder (PTSD) and Depression, run by Medical University of South Carolina.
Trial summary
This study evaluates the implementation and clinical effectiveness of the Trauma Resilience and Recovery Program (TRRP 2.0), a technology-enhanced behavioral health intervention designed for trauma center patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder (PTSD), Depression, Substance Use Disorder
- What is being tested?
- Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Admitted to a trauma center for ≥24 hours following injury
- English- or Spanish-speaking
Who cannot join
- Moderate to severe cognitive impairment
- Active psychosis
- Injury preventing verbal communication
- Self-inflicted injury
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes
This study evaluates the implementation and clinical effectiveness of the Trauma Resilience and Recovery Program (TRRP 2.0), a technology-enhanced behavioral health intervention designed for trauma center patients. TRRP 2.0 integrates screening, monitoring, and referral services for posttraumatic stress disorder (PTSD), depression, and substance use disorder (SUD).
The study uses a two-phase design across two trauma centers: a usual care phase followed by implementation of TRRP 2.0. A total of 300 adult trauma patients will be recruited and followed for 3 months to assess behavioral health service utilization and clinical outcomes.
Read the detailed description
Each year, over 600,000 of the 3 million U.S. patients hospitalized for traumatic injuries develop PTSD or depression within a year post-injury. Despite the 2022 American College of Surgeons (ACS) mandate for routine mental health screening and treatment, many trauma centers struggle to implement effective programs due to a lack of clear implementation roadmaps and operational barriers. The Trauma Resilience and Recovery Program (TRRP), developed by the Medical University of South Carolina (MUSC), addresses these gaps with a comprehensive, evidence-based intervention designed to meet the behavioral health needs of trauma patients. TRRP includes a web-based, HIPAA-compliant provider navigator platform that is cost-efficient and unique in its ability to facilitate improved screening accuracy at the bedside and efficient screening and referral post-discharge. The TRRP model and navigator platform have been used and sustained at MUSC since 2015 and have been adopted by over a dozen trauma centers. However, while adopters have noted several benefits of the platform, they emphasize two top-priority needs to facilitate adherence to ACS guidelines, ensure workload efficiencies that reduce provider burden, and minimize patient data capture errors: 1) integration of resources to facilitate screening and intervention for substance use disorders (SUD), and 2) the ability to read from and write to the electronic medical record (EMR). In this Phase I STTR, FRD Accel will partner with the MUSC team to enhance and de-risk an upgraded navigation platform-TRRP 2.0-to improve its scalability nationally in preparation for commercial launch. Our upgraded TRRP 2.0 platform will add features for integrated screening, intervention, and referral for SUD in addition to PTSD and depression. This will reduce provider burden and ensure compliance with ACS guidelines, promoting comprehensive care and optimizing patient outcomes. The specific aims for Phase I STTR are to 1) improve the TRRP platform by integrating new resources to facilitate the screening and referral of trauma patients with SUD and enabling communication with the Epic EMR (months 1-8), and 2) evaluate the clinical effectiveness of the TRRP 2.0 platform on post-discharge follow-up, behavioral health service utilization, and mental health outcomes among a sample of 300 adult trauma injury survivors (months 3-22). Successful completion of Phase I will validate TRRP 2.0's capacity to meet trauma centers' needs for integrated behavioral health services. The anticipated results will demonstrate the platform's ability to enhance patient care, streamline provider workflows, and ensure adherence to ACS standards. This will justify the transition to Phase II, where we will focus on broader dissemination, further development, and commercialization of the platform to maximize its impact across trauma centers nationwide.
- Conditions
- Post-Traumatic Stress Disorder (PTSD), Depression, Substance Use Disorder, Traumatic Injury
- Being tested
- Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)
- Keywords
- Trauma care, Behavioral health, Post-Traumatic Stress Disorder (PTSD), Depression, Substance use
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)Behavioural
TRRP 2.0 is an enhanced, technology-supported behavioral health care model for patients hospitalized after traumatic injury. The intervention includes bedside behavioral health and substance use screening, education about emotional recovery, enrollment in post-discharge follow-up services, automated symptom monitoring and education via text messaging, follow-up behavioral health screening, and referral to treatment when indicated. The TRRP 2.0 provider navigation platform supports delivery and tracking of these services and includes integrated substance use screening/intervention resources and Epic electronic medical record read/write functionality.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | ACS adherent usual care for SBIRT and Behavioral Health Screening and Referral Receives: Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) |
| TRRP 2.0 | Experimental | Service delivery via TRRP 2.0 Receives: Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Symptom Severity as Measured by the PCL-8
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.
Measured: 3-month post-baseline
Number of Participants Screening Positive for Posttraumatic Stress Risk on the Injured Trauma Survivor Screen (ITSS)
Posttraumatic stress risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of posttraumatic stress.
Measured: Baseline
Change in Psychological Distress as Measured by the Kessler-6 (K6)
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 ³ 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.
Measured: Baseline, 3-month postbaseline
Depressive Symptom Severity as Measured by the PHQ-8
The Patient Health Questionniare-9 (PHQ-9;
Kroenke, Spitzer, \& Williams, 2001) 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 months postbaseline
Frequency of Alcohol Use as Measured by the NIDA Quick Screen
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.
Measured: 3 months postbaseline
General Life Satisfaction as Measured by PROMIS General Life Satisfaction
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.
Measured: 3 months postbaseline
Frequency of Tobacco Use as Measured by the NIDA Quick Screen
Tobacco use is assessed using the NIDA Quick Screen. Participants report the frequency of tobacco product use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Measured: 3 months postbaseline
Frequency of Prescription Drug Use for Nonmedical Reasons as Measured by the NIDA Quick Screen
Nonmedical prescription drug use is assessed using the NIDA Quick Screen. Participants report frequency of prescription drug use for nonmedical reasons during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Measured: 3 months postbaseline
Frequency of Illegal Drug Use as Measured by the NIDA Quick Screen
Illegal drug use is assessed using the NIDA Quick Screen. Participants report frequency of illegal drug use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Measured: 3 months postbaseline
Number of Participants Screening Positive for Depression Risk on the Injured Trauma Survivor Screen (ITSS)
Depression risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of depression.
Measured: Baseline
Secondary outcomes (8)
Hospital Length of Stay
Length of stay for the index traumatic injury hospitalization will be obtained from the electronic medical record and reported in days.
Measured: Baseline
Electronic Medical Record Data
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
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 (CDC, 2019) designed to
assess when medical care was last sought, usual
place of care, frequency of getting medical treatment.
Measured: 3 months postbaseline
Injury Severity Score (ISS)
Injury Severity Score associated with the index traumatic injury will be obtained from the electronic medical record. ISS ranges from 1 to 75, with higher scores indicating greater injury severity.
Measured: Baseline
Number of Emergency Department Visits
Number of emergency department visits occurring during the specified period will be obtained from the electronic medical record.
Measured: 3 months postbaseline
Number of Participants Prescribed Opioid Medication
Number of participants with an opioid medication prescription documented in the electronic medical record during the specified period.
Measured: 3 months postbaseline
Number of Participants Prescribed Anti-Anxiety Medication
Number of participants with an anti-anxiety medication prescription documented in the electronic medical record during the specified period.
Measured: 3 months postbaseline
Number of Participants Prescribed Antidepressant Medication
Number of participants with an antidepressant medication prescription documented in the electronic medical record during the specified period.
Measured: 3 months postbaseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder (PTSD)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study uses a sequential, two-phase pre-post implementation design conducted at two Level I trauma centers. During the usual-care phase, 150 participants (75/site) will receive each center's standard ACS guideline-adherent behavioral health screening, education, and referral services. Following implementation of TRRP 2.0, an additional 150 participants (75/site) will receive TRRP services supported by the enhanced platform. Participants in both phases will complete baseline and 3-month assessments. Outcomes will be compared between the usual-care and TRRP 2.0 implementation phases to evaluate behavioral health service engagement and clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Davidson, Medical University of South Carolina
- Investigators
- Tatiana Davidson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829510
- Sponsor's protocol ID
- Pro00151208
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes
- ClinicalTrials.gov ID
- NCT07829510
- Acronym / sponsor ID
- Pro00151208
- Conditions
- Post-Traumatic Stress Disorder (PTSD), Depression, Substance Use Disorder, Traumatic Injury
- Keywords
- Trauma care, Behavioral health, Post-Traumatic Stress Disorder (PTSD), Depression, Substance use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 21 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 study evaluates the implementation and clinical effectiveness of the Trauma Resilience and Recovery Program (TRRP 2.0), a technology-enhanced behavioral health intervention designed for trauma center patients. TRRP 2.0 integrates screening, monitoring, and referral services for posttraumatic stress disorder (PTSD), depression, and substance use disorder (SUD).
The study uses a two-phase design across two trauma centers: a usual care phase followed by implementation of TRRP 2.0. A total of 300 adult trauma patients will be recruited and followed for 3 months to assess behavioral health service utilization and clinical outcomes.
Detailed description
Each year, over 600,000 of the 3 million U.S. patients hospitalized for traumatic injuries develop PTSD or depression within a year post-injury. Despite the 2022 American College of Surgeons (ACS) mandate for routine mental health screening and treatment, many trauma centers struggle to implement effective programs due to a lack of clear implementation roadmaps and operational barriers. The Trauma Resilience and Recovery Program (TRRP), developed by the Medical University of South Carolina (MUSC), addresses these gaps with a comprehensive, evidence-based intervention designed to meet the behavioral health needs of trauma patients. TRRP includes a web-based, HIPAA-compliant provider navigator platform that is cost-efficient and unique in its ability to facilitate improved screening accuracy at the bedside and efficient screening and referral post-discharge. The TRRP model and navigator platform have been used and sustained at MUSC since 2015 and have been adopted by over a dozen trauma centers. However, while adopters have noted several benefits of the platform, they emphasize two top-priority needs to facilitate adherence to ACS guidelines, ensure workload efficiencies that reduce provider burden, and minimize patient data capture errors: 1) integration of resources to facilitate screening and intervention for substance use disorders (SUD), and 2) the ability to read from and write to the electronic medical record (EMR). In this Phase I STTR, FRD Accel will partner with the MUSC team to enhance and de-risk an upgraded navigation platform-TRRP 2.0-to improve its scalability nationally in preparation for commercial launch. Our upgraded TRRP 2.0 platform will add features for integrated screening, intervention, and referral for SUD in addition to PTSD and depression. This will reduce provider burden and ensure compliance with ACS guidelines, promoting comprehensive care and optimizing patient outcomes. The specific aims for Phase I STTR are to 1) improve the TRRP platform by integrating new resources to facilitate the screening and referral of trauma patients with SUD and enabling communication with the Epic EMR (months 1-8), and 2) evaluate the clinical effectiveness of the TRRP 2.0 platform on post-discharge follow-up, behavioral health service utilization, and mental health outcomes among a sample of 300 adult trauma injury survivors (months 3-22). Successful completion of Phase I will validate TRRP 2.0's capacity to meet trauma centers' needs for integrated behavioral health services. The anticipated results will demonstrate the platform's ability to enhance patient care, streamline provider workflows, and ensure adherence to ACS standards. This will justify the transition to Phase II, where we will focus on broader dissemination, further development, and commercialization of the platform to maximize its impact across trauma centers nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a sequential, two-phase pre-post implementation design conducted at two Level I trauma centers. During the usual-care phase, 150 participants (75/site) will receive each center's standard ACS guideline-adherent behavioral health screening, education, and referral services. Following implementation of TRRP 2.0, an additional 150 participants (75/site) will receive TRRP services supported by the enhanced platform. Participants in both phases will complete baseline and 3-month assessments. Outcomes will be compared between the usual-care and TRRP 2.0 implementation phases to evaluate behavioral health service engagement and clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)ACS adherent usual care for SBIRT and Behavioral Health Screening and Referral |
| TRRP 2.0 | Experimental | Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)Service delivery via TRRP 2.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Admitted to a trauma center for ≥24 hours following injury
- English- or Spanish-speaking
Key exclusion criteria (4 listed)
- Moderate to severe cognitive impairment
- Active psychosis
- Injury preventing verbal communication
- 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 |
|---|---|---|
| Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)TRRP 2.0 is an enhanced, technology-supported behavioral health care model for patients hospitalized after traumatic injury. The intervention includes bedside behavioral health and substance use screening, education about emotional recovery, enrollment in post-discharge follow-up services, automated symptom monitoring and education via text messaging, follow-up behavioral health screening, and referral to treatment when indicated. The TRRP 2.0 provider navigation platform supports delivery and tracking of these services and includes integrated substance use screening/intervention resources and Epic electronic medical record read/write functionality. | Behavioural | TRRP 2.0, Usual Care |
Primary outcome
Posttraumatic Stress Symptom Severity as Measured by the PCL-8
Time frame: 3-month 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.
Number of Participants Screening Positive for Posttraumatic Stress Risk on the Injured Trauma Survivor Screen (ITSS)
Time frame: Baseline
Posttraumatic stress risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of posttraumatic stress.
Change in Psychological Distress as Measured by the Kessler-6 (K6)
Time frame: Baseline, 3-month postbaseline
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 ³ 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.
Depressive Symptom Severity as Measured by the PHQ-8
Time frame: 3 months postbaseline
The Patient Health Questionniare-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) 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.
Frequency of Alcohol Use as Measured by the NIDA Quick Screen
Time frame: 3 months postbaseline
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.
General Life Satisfaction as Measured by PROMIS General Life Satisfaction
Time frame: 3 months postbaseline
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.
Frequency of Tobacco Use as Measured by the NIDA Quick Screen
Time frame: 3 months postbaseline
Tobacco use is assessed using the NIDA Quick Screen. Participants report the frequency of tobacco product use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Frequency of Prescription Drug Use for Nonmedical Reasons as Measured by the NIDA Quick Screen
Time frame: 3 months postbaseline
Nonmedical prescription drug use is assessed using the NIDA Quick Screen. Participants report frequency of prescription drug use for nonmedical reasons during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Frequency of Illegal Drug Use as Measured by the NIDA Quick Screen
Time frame: 3 months postbaseline
Illegal drug use is assessed using the NIDA Quick Screen. Participants report frequency of illegal drug use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.
Number of Participants Screening Positive for Depression Risk on the Injured Trauma Survivor Screen (ITSS)
Time frame: Baseline
Depression risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of depression.
8 secondary outcomes
Hospital Length of Stay
Time frame: Baseline
Electronic Medical Record Data
Time frame: Baseline
National Health Interview Survey Adult Access to Health Care and Utilization Module
Time frame: 3 months postbaseline
Injury Severity Score (ISS)
Time frame: Baseline
Number of Emergency Department Visits
Time frame: 3 months postbaseline
Number of Participants Prescribed Opioid Medication
Time frame: 3 months postbaseline
Number of Participants Prescribed Anti-Anxiety Medication
Time frame: 3 months postbaseline
Number of Participants Prescribed Antidepressant Medication
Time frame: 3 months postbaseline
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Tatiana Davidson, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) in people with Post-Traumatic Stress Disorder (PTSD) and Depression, run by Medical University of South Carolina.
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 3 inclusion and 4 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Tatiana Davidson, PhD (8437920979, davidst@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Symptom Severity as Measured by the PCL-8 (time frame: 3-month post-baseline). The study lists 10 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 21 Sep 2026.