PTSDTSOS 8NCT05632770
A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems
A study testing Stepped Collaborative Care in people with PTSD and Physical Injury, run by University of Washington at 1 site in United States.
Trial summary
This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Physical Injury
- What is being tested?
- Stepped Collaborative Care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 31 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Injured patients ≥18 years of age
- Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen
- Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) .
- Speak English and/or Spanish
Who cannot join
- Age <18
- Not admitted for a traumatic injury
- Speak a language other than English and/or Spanish
- Acutely suicidal/admitted for a suicide attempt
- Cognitively impaired
- Incarcerated
Show all 12Show fewer
- Acutely psychotic
- Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada
- Less than 2 pieces of contact information
- Prior history of violence, such that study staff may not be safe
- Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition
- Most recent COVID-19 test positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.
Read the detailed description
Life-threatening traumatic exposures requiring presentation to acute care medical settings are endemic in the US in the era of the COVID-19 pandemic, firearm proliferation, and extreme weather events, and constitute both a substantial source of individual suffering and a significant public health burden. Each year in the US, over 30 million individuals present to acute care medical settings after injury, and approximately 2.5 million individuals are so severely injured that they require inpatient hospital admissions. The overarching goal of the Trauma Survivors Outcomes and Support (TSOS) investigation is to advance the sustainable delivery of high quality trauma center mental health screening, intervention and referral procedures for diverse injury survivors. Over the past two decades, the TSOS study team that includes research scientists, trauma surgical policymakers, patients, and frontline clinicians has established a track record of using evidence derived from NIH pragmatic trials to directly target American College of Surgeons Committee on Trauma (College) regulatory policy. The TSOS investigation will refine and test optimal stepped care intervention strategies for diverse injury survivors presenting to acute care medical settings with PTSD and associated comorbidity. This single trauma center site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required screening and referral control conditions. The stepped care intervention consists of proactive care management, as well as medications and psychotherapy elements targeting PTSD and comorbidity. Blinded follow-up interviews at 1-, 3-, 6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department health information exchange will be used to capture population-level automated emergency department/inpatient utilization data for the intent-to-treat sample. The investigation aims to test the primary hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and emergency department/inpatient utilization when compared to control patients. The investigation will also explore mediators and moderators of intervention treatment effects that directly address actionable national trauma center quality improvements. A mixed method Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) implementation process assessment will facilitate the integration of study results into national College policy requirements, guidelines, and verification criteria. A national trauma center survey will elucidate the progression of PTSD and comorbidity screening, intervention and referral for all US level I and II trauma centers. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high quality acute care medical mental health services for diverse patient populations.
- Conditions
- PTSD, Physical Injury
- Being tested
- Stepped Collaborative Care, American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
- Keywords
- PTSD, Physical Injury, Emergency Department Utilization
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Collaborative CareBehavioural
Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
American College of Surgeons (ACS) Required Screening and Referral (Usual Care)Behavioural
The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Collaborative Care (Intervention) | Experimental | Patients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity. Receives: Behavioral: Stepped Collaborative Care |
| American College of Surgeons (ACS) Required Screening and Referral (Usual Care) | Active comparator | Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral. Receives: Behavioral: American College of Surgeons (ACS) Required Screening and Referral (Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder (PTSD) symptoms change over time
The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Emergency department utilization change over time
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
Measured: Baseline injury admission to 12-months post-injury follow-up
Secondary outcomes (5)
Alcohol use change over time
The investigators will use the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure. The 3-item scale score ranges from 0-12, with higher values indicating a worse outcome.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Mental and physical functioning change over time
The Medical Outcomes Study Short Form healthy survey (SF-12) will be used as a continuous measure. The 12-item scale score ranges from 0-100, with higher scores representing a better outcome. The two summary measures, Physical Component Summary (PCS) and Mental Component Summary (MCS), will be scored.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Depression symptoms change over time
The Patient Health Questionnaire 9-item Depression Scale (PHQ-9) will be used to assess symptoms of depression. The scoring of the scale ranges from 0-27, with higher scores indicating a worse outcome. The scale can also be dichotomized to indicate depressive symptom cutoffs and DSM depressive disorder criteria.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Suicide risk assessment change over time
The Columbia Suicide Severity Rating Scale (CSSRS) is a 6-item questionnaire to assess risk of suicide. The scoring of the scale ranges from 2-25, with higher scores indicating a worse outcome.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Substance use change over time
Single items self report that assesses opioid use, amphetamines, cocaine and marijuana. Single item self-report are categorically rated from no use to use four or more times a week.
Measured: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start9 Jan 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 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 PTSDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Douglas Zatzick, University of Washington
- Investigators
- Douglas Zatzick, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632770
- Sponsor's protocol ID
- STUDY00015632
- Other IDs
- R01MH130460
- Acronym
- TSOS 8
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knutzen T, Bulger E, Iles-Shih M, Hernandez A, Engstrom A, Whiteside L, Birk N, Abu K, Shoyer J, Conde C, Ryan P, Wang J, Russo J, Heagerty P, Palinkas L, Zatzick D. Stepped collaborative care versus American College of Surgeons Committee on Trauma required screening and referral for posttraumatic stress disorder: Clinical trial protocol. Contemp Clin Trials. 2024 Jan;136:107380. doi: 10.1016/j.cct.2023.107380. Epub 2023 Nov 10.
PubMed 37952714
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems
- ClinicalTrials.gov ID
- NCT05632770
- Acronym / sponsor ID
- TSOS 8 / STUDY00015632
- Conditions
- PTSD, Physical Injury
- Keywords
- PTSD, Physical Injury, Emergency Department Utilization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Dec 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.
This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.
Detailed description
Life-threatening traumatic exposures requiring presentation to acute care medical settings are endemic in the US in the era of the COVID-19 pandemic, firearm proliferation, and extreme weather events, and constitute both a substantial source of individual suffering and a significant public health burden. Each year in the US, over 30 million individuals present to acute care medical settings after injury, and approximately 2.5 million individuals are so severely injured that they require inpatient hospital admissions. The overarching goal of the Trauma Survivors Outcomes and Support (TSOS) investigation is to advance the sustainable delivery of high quality trauma center mental health screening, intervention and referral procedures for diverse injury survivors. Over the past two decades, the TSOS study team that includes research scientists, trauma surgical policymakers, patients, and frontline clinicians has established a track record of using evidence derived from NIH pragmatic trials to directly target American College of Surgeons Committee on Trauma (College) regulatory policy. The TSOS investigation will refine and test optimal stepped care intervention strategies for diverse injury survivors presenting to acute care medical settings with PTSD and associated comorbidity. This single trauma center site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required screening and referral control conditions. The stepped care intervention consists of proactive care management, as well as medications and psychotherapy elements targeting PTSD and comorbidity. Blinded follow-up interviews at 1-, 3-, 6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department health information exchange will be used to capture population-level automated emergency department/inpatient utilization data for the intent-to-treat sample. The investigation aims to test the primary hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and emergency department/inpatient utilization when compared to control patients. The investigation will also explore mediators and moderators of intervention treatment effects that directly address actionable national trauma center quality improvements. A mixed method Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) implementation process assessment will facilitate the integration of study results into national College policy requirements, guidelines, and verification criteria. A national trauma center survey will elucidate the progression of PTSD and comorbidity screening, intervention and referral for all US level I and II trauma centers. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high quality acute care medical mental health services for diverse patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Collaborative Care (Intervention) | Experimental | Behavioral: Stepped Collaborative CarePatients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity. |
| American College of Surgeons (ACS) Required Screening and Referral (Usual Care) | Active comparator | Behavioral: American College of Surgeons (ACS) Required Screening and Referral (Usual Care)Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Injured patients ≥18 years of age
- Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen
- Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) .
- Speak English and/or Spanish
Key exclusion criteria (12 listed)
- Age <18
- Not admitted for a traumatic injury
- Speak a language other than English and/or Spanish
- Acutely suicidal/admitted for a suicide attempt
- Cognitively impaired
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 |
|---|---|---|
| Stepped Collaborative CareCase management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury. | Behavioural | Stepped Collaborative Care (Intervention) |
| American College of Surgeons (ACS) Required Screening and Referral (Usual Care)The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35. | Behavioural | American College of Surgeons (ACS) Required Screening and Referral (Usual Care) |
Primary outcome
Posttraumatic Stress Disorder (PTSD) symptoms change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Emergency department utilization change over time
Time frame: Baseline injury admission to 12-months post-injury follow-up
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
5 secondary outcomes
Alcohol use change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Mental and physical functioning change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Depression symptoms change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Suicide risk assessment change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Substance use change over time
Time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
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 29 Apr 2026.
- Derived from this study: PubMed 37952714Knutzen T, Bulger E, Iles-Shih M, Hernandez A, Engstrom A, Whiteside L, Birk N, Abu K, Shoyer J, Conde C, Ryan P, Wang J, Russo J, Heagerty P, Palinkas L, Zatzick D. Stepped collaborative care versus American College of Surgeons Committee on Trauma required screening and referral for posttraumatic stress disorder: Clinical trial protocol. Contemp Clin Trials. 2024 Jan;136:107380. doi: 10.1016/j.cct.2023.107380. Epub 2023 Nov 10.
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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. This study is not recruiting at the moment.
Douglas Zatzick, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Collaborative Care in people with PTSD and Physical Injury, run by University of Washington 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder (PTSD) symptoms change over time (time frame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up). The study lists 2 primary outcomes in all. 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 NCT05632770, 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 29 Apr 2026.