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Stepped Collaborative Care for PTSD (TSOS 8 Trial)

N/A

Recruiting

Led By Douglas Zatzick, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

Awards & highlights

TSOS 8 Trial Summary

This trial tests if a brief, stepped care intervention for PTSD can reduce symptoms and emergency department use.

Who is the study for?

This trial is for adults over 18 who've been hospitalized for a traumatic injury, have high PTSD symptoms, and meet certain risk criteria. They must speak English or Spanish and live in specific Western US states. Excluded are those under 18, non-trauma patients, non-English/Spanish speakers, cognitively impaired individuals, prisoners, residents outside the specified states with insufficient contact info or safety concerns due to violence history.Check my eligibility

What is being tested?

The study tests a stepped care approach versus usual trauma center care to see if it better reduces PTSD symptoms and emergency department visits post-injury. Participants will be randomly assigned to receive either the new intervention or standard screening and referral practices.See study design

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, side effects may include discomfort during therapy sessions or increased anxiety when discussing traumatic events but are generally considered low-risk compared to drug treatments.

TSOS 8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Emergency department utilization change over time

Posttraumatic Stress Disorder (PTSD) symptoms change over time

Secondary outcome measures

Alcohol use change over time

Depression symptoms change over time

Mental and physical functioning change over time

+2 more

TSOS 8 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stepped Collaborative Care (Intervention)Experimental Treatment1 Intervention

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.

Group II: American College of Surgeons (ACS) Required Screening and Referral (Usual Care)Active Control1 Intervention

Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,342 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,343 Total Patients Enrolled

Douglas Zatzick, MDPrincipal InvestigatorUniversity of Washington

4 Previous Clinical Trials

850 Total Patients Enrolled

Media Library

Stepped Collaborative Care Clinical Trial Eligibility Overview. Trial Name: NCT05632770 — N/A

Post-Traumatic Stress Disorder Research Study Groups: American College of Surgeons (ACS) Required Screening and Referral (Usual Care), Stepped Collaborative Care (Intervention)

Post-Traumatic Stress Disorder Clinical Trial 2023: Stepped Collaborative Care Highlights & Side Effects. Trial Name: NCT05632770 — N/A

Stepped Collaborative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632770 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are enrolled in this clinical exploration?

"Correct. The clinicaltrials.gov database indicates that, as of January 10th 20203, this trial is searching for 424 participants from one medical site to join their research endeavour. This study was initially posted on September 1st 2023 and has been modified since then."

Answered by AI

Are there current opportunities to join this medical experiment?

"Correct. Records hosted on clinicaltrials.gov attest to the fact that enrollment is open for this medical trial, which was initially published on January 9th 2023 and has been updated recently on January 10th 2023. 424 patients need to be recruited from 1 study site."

Answered by AI

What are the major aims of this clinical trial?

"The primary goal of this clinical trial, which will monitor participants' changes in symptoms at baseline injury admission and 1-, 3-, 6- and 12-months post-injury followup is to evaluate the alteration in Emergency department utilisation over time. As for secondary outcomes, measurements such as mental & physical functioning (as per SF-12 scoring), suicide risk assessment (CSSRS scoring) and depression symptom detection (PHQ-9 measurement) are also being taken into consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Douglas Zatzick 2023. "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. https://clinicaltrials.gov/ct2/show/NCT05632770.