424 Participants Needed

Stepped Collaborative Care for PTSD

(TSOS 8 Trial)

DZ
TK
Overseen ByTanya Knutsen, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Stepped Collaborative Care for PTSD is an effective treatment?

The available research shows that Stepped Collaborative Care for PTSD can lead to significant improvements in symptoms. For example, in a study involving veterans, 42.2% of participants reported a noticeable improvement in their PTSD symptoms. Another study in the Military Health System found that this treatment improved PTSD and depression outcomes compared to usual care. Additionally, a trial with injured trauma survivors showed that the treatment led to modest symptom reductions, especially noticeable at 3 and 6 months after the intervention. These findings suggest that Stepped Collaborative Care can be an effective way to manage PTSD.12345

What safety data exists for Stepped Collaborative Care for PTSD?

The provided research does not directly address safety data for Stepped Collaborative Care for PTSD or its related terms. The studies focus on adverse events in neuropsychiatry, patient safety data sharing, mental health legislation, occupational well-being in pediatricians, and support for healthcare workers after serious adverse events. None of these specifically evaluate the safety of Stepped Collaborative Care for PTSD.678910

Is Stepped Collaborative Care a promising treatment for PTSD?

Yes, Stepped Collaborative Care is a promising treatment for PTSD. It helps improve access to mental health care, supports early intervention, and has shown positive results in reducing PTSD symptoms.1241112

Research Team

DZ

Douglas Zatzick, MD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Inclusion Criteria

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)
I am 18 years old or older and have an injury.
See 1 more

Exclusion Criteria

Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition
Acutely psychotic
Most recent COVID-19 test positive
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a stepped collaborative care intervention including care management, medication, and psychotherapy targeting PTSD and comorbidity

12 months
Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up interviews at 1-, 3-, 6-, and 12-months post-injury

12 months
4 visits (in-person or virtual)

Treatment Details

Interventions

  • American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
  • Stepped Collaborative Care
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

A modified collaborative care program for PTSD was successfully implemented in VA primary care, with 239 patients referred and nearly 185 enrolling over a period from November 2012 to March 2017.
Among those who participated, over half (53.4%) showed significant improvement in depression symptoms, and 42.2% reported significant improvement in PTSD symptoms, indicating the program's potential effectiveness in treating these conditions.
Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care.Chen, JA., Jakupcak, M., McCann, R., et al.[2022]
The study developed a stepped collaborative care intervention for PTSD, involving 207 acutely injured trauma survivors, which integrated care management with cognitive behavioral therapy and pharmacotherapy.
This approach was successfully implemented by social work and nurse practitioner providers in acute care settings, suggesting that it can effectively extend early trauma-focused interventions to a broader population of trauma survivors.
Enhancing the population impact of collaborative care interventions: mixed method development and implementation of stepped care targeting posttraumatic stress disorder and related comorbidities after acute trauma.Zatzick, D., Rivara, F., Jurkovich, G., et al.[2023]
The STEPS-UP model, a stepped and centrally assisted collaborative care approach, significantly increased the utilization of mental health services and psychiatric medications among 666 patients with PTSD and depression compared to usual collaborative care.
Patients with greater clinical complexity benefited more from the STEPS-UP model, receiving tailored care that matched their needs, which suggests this model can enhance the effectiveness of mental health treatment in military settings.
Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System.Belsher, BE., Jaycox, LH., Freed, MC., et al.[2018]

References

Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care. [2022]
Enhancing the population impact of collaborative care interventions: mixed method development and implementation of stepped care targeting posttraumatic stress disorder and related comorbidities after acute trauma. [2023]
Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System. [2018]
Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. [2018]
Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. [2022]
Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]
Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. [2014]
Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. [2020]
Second Victim Support at the Core of Severe Adverse Event Investigation. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Collaborative care interventions in general trauma patients. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
A pilot trial of telephone-based collaborative care management for PTSD among Iraq/Afghanistan war veterans. [2018]