Stepped Collaborative Care for PTSD

(TSOS 8 Trial)

Overseen By Tanya Knutsen, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Suicidal, Psychotic, Violence history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

424 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach called Stepped Collaborative Care to reduce symptoms of posttraumatic stress disorder (PTSD) and decrease emergency room visits. Participants will join one of two groups: one receiving usual care and the other receiving Stepped Collaborative Care, which includes medication, therapy, and personalized support. The trial seeks individuals who have been injured, exhibit significant PTSD symptoms, and speak English or Spanish.

As an unphased trial, this study offers a unique opportunity to contribute to innovative PTSD treatment research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stepped collaborative care is generally well-received by patients. In a study with 635 participants, this treatment significantly improved PTSD symptoms, indicating its safety and effectiveness for many people. Although the study focused on symptom reduction, it found no serious safety issues. Individual experiences may vary, but current evidence supports the safety of this approach for managing PTSD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepped Collaborative Care approach for PTSD because it offers a tailored, multi-faceted treatment plan that adapts to each patient's needs. Unlike the standard care, which often involves isolated interventions like medication or psychotherapy, this method combines posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements. This comprehensive strategy aims to tackle not only PTSD symptoms but also related mental health issues, potentially leading to more effective and faster recovery for patients.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Stepped Collaborative Care, which participants in this trial may receive, can help reduce symptoms of posttraumatic stress disorder (PTSD) in some patients. Specifically, studies found that this approach significantly reduced PTSD symptoms six months after treatment, particularly for non-white or Hispanic patients. This method combines care management, medication, and therapy to address PTSD and related issues. Although the benefits were clear at six months, the reduction in symptoms was not as strong after a year. Overall, this approach aims to make treatment more accessible and effective for those dealing with PTSD. ^{1 2 3 4 6}

Who Is on the Research Team?

Douglas Zatzick, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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)

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
• Stepped Collaborative Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Stepped Collaborative Care (Intervention) Experimental Treatment 1 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 Control 1 Intervention

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

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+

Published Research Related to This Trial

The pilot Patient Safety Presentation process, implemented in a psychiatry residency program, significantly improved residents' knowledge and engagement in patient safety practices, as evidenced by pre- and post-presentation surveys involving 32 residents.

All participating residents expressed satisfaction with the presentation, highlighting its effectiveness as a model for enhancing patient safety education in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. Kim, B., Grech, SM., Rembisz, AE., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The TIDES/PTSD model, a telephone-based collaborative care approach, was successfully implemented for Iraq/Afghanistan veterans with PTSD, showing high acceptability among patients and staff.

Participants experienced a significant reduction in PTSD symptoms during treatment, with more care manager calls correlating positively with increased psychiatry visits and greater symptom improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of telephone-based collaborative care management for PTSD among Iraq/Afghanistan war veterans. Hoerster, KD., Jakupcak, M., Stephenson, KR., et al.[2018]

Adverse events in mental health care are common and can lead to significant distress and even death, highlighting the need for improved practices in treatment and discharge processes.

The study identifies critical areas for improvement, including assessment processes, communication, documentation, and training, to reduce the frequency of these adverse events based on coronial recommendations in three Australian States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. Smith-Merry, J., Caple, A.[2014]

Collaborative care strategies effectively integrate mental health interventions into trauma care, showing promise in reducing symptoms of PTSD and alcohol use among injured patients, based on initial randomized clinical trials.

These interventions can be feasibly implemented in trauma centers, linking immediate care to outpatient services, which may enhance the overall quality of mental health care for trauma victims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care interventions in general trauma patients. Petrie, M., Zatzick, D.[2023]

Rural veterans with PTSD who participated in a telemedicine-based collaborative care intervention showed higher rates of initiating and engaging in cognitive processing therapy (CPT) compared to those receiving usual care, indicating the effectiveness of this approach.

However, veterans with more severe PTSD symptoms and comorbid major depression were less likely to start or complete CPT, suggesting that these factors may hinder access to effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. Grubbs, KM., Fortney, JC., Pyne, JM., et al.[2018]

A pragmatic clinical trial involving 121 acutely injured trauma survivors showed that an IT-enhanced collaborative care intervention for PTSD resulted in modest symptom reductions, particularly significant at 3 and 6 months post-injury.

The intervention required a median of only 2.25 hours per patient, suggesting that this model could provide an efficient way to deliver PTSD treatment without extensive clinical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. Zatzick, D., O'Connor, SS., Russo, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care. Chen, JA., Jakupcak, M., McCann, R., et al.[2022]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A significant 79% of pediatricians reported experiencing adverse events, with 'missing a diagnosis' being the most emotionally impactful and 'aggressive behavior' the most common, leading to higher rates of mental health issues compared to the general population.

Only 26.3% of pediatricians had access to a peer support protocol for emotional support after adverse events, highlighting the need for structured support systems and education on coping strategies to improve their mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. van Steijn, ME., Scheepstra, KWF., Yasar, G., et al.[2020]

A second victim support intervention was implemented in a 500-bed University Hospital in Granada, Spain, providing structured emotional support to healthcare workers involved in serious adverse events (SAEs) over two years, with 135 workers receiving second-level support.

The intervention led to increased notification rates of SAEs and high acceptance among professionals, enhancing the visibility of support actions and contributing to a stronger culture of patient safety within the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. Cobos-Vargas, A., Pérez-Pérez, P., Núñez-Núñez, M., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33688908/

Stepped Collaborative Care Targeting Posttraumatic Stress ... A brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7948109/

Stepped Collaborative Care Targeting Posttraumatic Stress ... In this study, a well-implemented brief intervention for injured patients reduced posttraumatic stress disorder symptoms.

3. tsaco.bmj.com tsaco.bmj.com/content/9/1/e001232

Can stepped collaborative care interventions improve post ... A brief stepped collaborative care intervention was associated with greater 6-month reductions in PTSD symptoms for non-white/Hispanic patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789422001411

Systematic Review and Meta-Analysis of Stepped Care ... Stepped care approaches have been developed to increase treatment accessibility for individuals with posttraumatic stress disorder (PTSD).

5. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2023.2254235

Stepped collaborative care for pain and posttraumatic ... Survival rates and functional outcomes following traumatic injury have significantly improved in recent years [1]. However, recent research has shown that ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834311000028

Enhancing the population impact of collaborative care ... The objective of the study was to develop and implement a stepped collaborative care intervention targeting posttraumatic stress disorder (PTSD) and related ...