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Posttraumatic Stress DisorderTSOS6NCT02655354

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

A study testing Motivational Interviewing, Cognitive Behavioral Therapy Elements and Care Management in people with Posttraumatic Stress Disorder and Depression, run by University of Washington at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Motivational Interviewing, Cognitive Behavioral Therapy Elements and Care Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
635 participants
Where
24 sitesUnited States
Study dates
Oct 2015to Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient currently admitted to inpatient/emergency department for a traumatic injury

Who cannot join

  • Non-English speaking
  • Self-inflicted injury
  • Actively psychotic
  • Incarcerated or in custody
  • Less than 35 on PTSD Checklist
  • Less than 3 items on PTSD medical record screen
  • Less than 2 pieces of contact information

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Georgia Regents

    Augusta, Georgia, 30912

  • Cedars Sinai

    Beverly Hills, California, 90211

  • The University of Vermont

    Burlington, Vermont, 05405

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Ohio State University

    Columbus, Ohio, 43210

  • Baylor Health Care System

    Dallas, Texas, 75204

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Inova Trauma Center

    Falls Church, Virginia, 22042

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Eskenazi Health

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Kentucky

    Lexington, Kentucky, 40536

  • The University of Wisconsin Madison

    Madison, Wisconsin, 53715

  • Louisiana State University

    New Orleans, Louisiana, 70112

  • University of Rochester

    Rochester, New York, 14642

  • U.C. Davis

    Sacramento, California, 95816

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • The University of Utah

    Salt Lake City, Utah, 84132

  • Santa Clara Valley Medical Center

    San Jose, California, 95128

  • Honor Health

    Scottsdale, Arizona, 85251

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • U.C.L.A. Harbor

    Torrance, California, 90509

  • Wake Forest

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.

Read the detailed description

Primary Aims and Hypotheses

The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function.

A Priori Secondary Analyses

The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.

Being tested
Motivational Interviewing, Cognitive Behavioral Therapy Elements, Care Management, Fluoxetine, Fluvoxamine
Medical subject headings
Stress Disorders, Post-Traumatic, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Cognitive Dysfunction, Pain, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational InterviewingBehavioural

  • Cognitive Behavioral Therapy ElementsBehavioural

  • Care ManagementBehavioural

  • FluoxetineDrug

    Anti-depressant

  • FluvoxamineDrug

    Anti-depressant

  • ParoxetineDrug

    Anti-depressant

  • SertralineDrug

    Anti-depressant

  • CitalopramDrug

    Anti-depressant

  • VenlafaxineDrug

    Anti-depressant

  • DuloxetineDrug

    Anti-depressant

  • MirtazapineDrug

    Anti-depressant

  • DiphenhydramineDrug

    Sleep medication

  • TrazodoneDrug

    Sleep medication

  • PrazosinDrug

    Sleep medication

Study groups in NCT02655354
Study groupRoleWhat they receive
InterventionExperimentalThe intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.
Receives: Behavioral: Motivational Interviewing; Behavioral: Cognitive Behavioral Therapy Elements; Behavioral: Care Management; Drug: Fluoxetine; Drug: Fluvoxamine; Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Duloxetine; Drug: Mirtazapine; Drug: Diphenhydramine; Drug: Trazodone; Drug: Prazosin
Usual CareNo interventionEnhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury

    The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

    Measured: Baseline, 3-month, 6-month, 12-month

  2. Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury

    The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.

    Measured: Baseline, 3-month, 6-month, 12-month

  3. Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury

    The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.

    Measured: Baseline, 3-month, 6-month, 12-month

  4. Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury

    The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.

    Measured: Baseline, 3-month, 6-month, 12-month

Secondary outcomes (9)

  1. Number of Participants With Suicidal Ideation

    Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.

    Measured: Baseline, 3-month, 6-month, 12-month

  2. Number of Participants Endorsing a Single Item That Assesses Opioid Use

    Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.

    Measured: Baseline, 3-month, 6-month, 12-month

  3. Cognitive Impairment Scale

    The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.

    Measured: Baseline, 3-month, 6-month, 12-month

  4. Brief Pain Inventory

    A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.

    Measured: Baseline, 3-month, 6-month, 12-month

  5. SF-36 Quality of Life

    The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.

    Measured: Baseline, 3-month, 6-month, 12-month

  6. TSOS Patient Satisfaction: Overall Health Care

    Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

    Measured: Baseline, 3-month, 6-month, 12-month

  7. Number of Participants Endorsing a Single Item That Assesses Stimulant Use

    Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.

    Measured: Baseline, 3-month, 6-month, 12-month

  8. Number of Participants Endorsing a Single Item That Assesses Marijuana Use

    Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.

    Measured: Baseline, 3-month, 6-month, 12-month

  9. TSOS Patient Satisfaction: Mental Health Care

    Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

    Measured: Baseline, 3 Month, 6 Month, 12 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2019
  4. Study completionNov 2019

Resources

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
635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655354
Sponsor's protocol ID
20150987
Other IDs
UH3MH106338
Acronym
TSOS6
Status last verified
Jul 2021
First submitted
27 Jul 2015
Last updated
2 Jul 2021
Data monitoring committee
No

Publications

  • Abu K, Bedard-Gilligan M, Moodliar R, Bulger EM, Hernandez A, Knutzen T, Shoyer J, Birk N, Conde C, Engstrom A, Ryan P, Wang J, Russo J, Zatzick DF. Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors? Trauma Surg Acute Care Open. 2024 Jan 24;9(1):e001232. doi: 10.1136/tsaco-2023-001232. eCollection 2024.

    PubMed 38287923

  • Zatzick D, Palinkas L, Chambers DA, Whiteside L, Moloney K, Engstrom A, Prater L, Russo J, Wang J, Abu K, Iles-Shih M, Bulger E. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis. Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.

    PubMed 37085877

  • Nguyen J, Whiteside LK, Bulger EM, Veach L, Moloney K, Russo J, Nehra D, Wang J, Zatzick DF. Post-traumatic stress disorder (PTSD) symptoms and alcohol and drug use comorbidity at 25 US level I trauma centers. Trauma Surg Acute Care Open. 2022 Aug 4;7(1):e000913. doi: 10.1136/tsaco-2022-000913. eCollection 2022.

    PubMed 35979039

  • Engstrom A, Moloney K, Nguyen J, Parker L, Roberts M, Moodliar R, Russo J, Wang J, Scheuer H, Zatzick D. A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study. Psychiatry. 2022 Spring;85(1):13-29. doi: 10.1080/00332747.2021.1991200. Epub 2021 Dec 21.

    PubMed 34932440

  • Nehra D, Bulger EM, Maier RV, Moloney KE, Russo J, Wang J, Anderson K, Zatzick DF. A Prospective US National Trauma Center Study of Firearm Injury Survivors Weapon Carriage and Posttraumatic Stress Disorder Symptoms. Ann Surg. 2021 Oct 1;274(4):e364-e369. doi: 10.1097/SLA.0000000000005043.

    PubMed 34225296

  • Zatzick D, Jurkovich G, Heagerty P, Russo J, Darnell D, Parker L, Roberts MK, Moodliar R, Engstrom A, Wang J, Bulger E, Whiteside L, Nehra D, Palinkas LA, Moloney K, Maier R. Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):430-474. doi: 10.1001/jamasurg.2021.0131.

    PubMed 33688908

  • Zatzick DF, Russo J, Darnell D, Chambers DA, Palinkas L, Van Eaton E, Wang J, Ingraham LM, Guiney R, Heagerty P, Comstock B, Whiteside LK, Jurkovich G. An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. Implement Sci. 2016 Apr 30;11:58. doi: 10.1186/s13012-016-0424-4.

    PubMed 27130272

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing, Cognitive Behavioral Therapy Elements and Care Management in people with Posttraumatic Stress Disorder and Depression, run by University of Washington at 24 sites 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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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?

Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury (time frame: Baseline, 3-month, 6-month, 12-month). The study lists 4 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 NCT02655354, which also lists 7 linked publications.

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 2 Jul 2021.

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