Health Services Intervention for PTSD

Overseen By Nicholas Holder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Inability to consent, Cognitive impairment, Active psychosis

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on therapy treatments for PTSD, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the New Health Services Intervention treatment for PTSD?

Research shows that collaborative care interventions, which include elements like care management and psychotherapy, have been effective in reducing PTSD symptoms. Additionally, specialized outpatient treatments have shown significant improvements in PTSD care, suggesting that structured and evidence-based approaches can be beneficial. ^{1 2 3 4 5}

Is the Health Services Intervention for PTSD safe for humans?

The research does not provide specific safety data for the Health Services Intervention for PTSD, but it mentions that PTSD treatments have been extensively studied, with data available in the PTSD Trials Standardized Data Repository. This repository can be a resource for safety information on various PTSD interventions. ^{3 6 7 8 9}

How is the New Health Services Intervention treatment for PTSD different from other treatments?

The New Health Services Intervention for PTSD is unique because it focuses on integrating mental health care into primary care settings, making it more accessible and reducing stigma. This approach allows for brief, effective treatments to be delivered by behavioral health providers within primary care, which is different from traditional, longer-term specialty care. ^{2 10 11 12 13}

Research Team

Nicholas Holder, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for Veterans diagnosed with PTSD at the San Francisco Veterans Affairs Medical Center. Participants must be able to give informed consent and understand study materials. Those with cognitive impairments or active psychosis cannot join.

Inclusion Criteria

I was diagnosed with PTSD at the San Francisco Veterans Affairs Medical Center.

The study is only open to military veterans.

Exclusion Criteria

I understand the study materials.

Inability to provide informed consent

You are currently experiencing severe mental illness that may affect your ability to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stabilization Treatment

Participants receive stabilization treatment, which includes combinations of psychosocial and medication treatments to prepare for CPT or PE

8-12 weeks

Transition to Recommended PTSD Treatment

Participants transition to cognitive processing therapy (CPT) or prolonged exposure therapy (PE) as part of the intervention

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• New Health Services Intervention
• Treatment As Usual

Trial Overview The study is examining how different treatment sequences affect starting recommended PTSD therapies like Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE). It includes developing a new health service intervention to help transition into these therapies.

Participant Groups

Group I: New Health Services Intervention Experimental Treatment 1 Intervention

Novel health services intervention with a VA mental health treatment coordinator

Group II: TAU Active Control 1 Intervention

Treatment As Usual with a VA mental health treatment coordinator

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

White River Junction Veterans Affairs Medical Center

Collaborator

Trials

32

Recruited

17,900+

Findings from Research

In a study of 2,643 veterans receiving treatment for PTSD, 25.9% experienced substantial improvement in symptoms, while 74.1% showed modest improvement, indicating that significant progress is possible in routine clinical practice.

The only strong predictor of substantial improvement was gender, with men having lower odds of achieving significant symptom reduction compared to women, suggesting that treatment approaches may need to be tailored based on gender differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. Shiner, B., Gui, J., Leonard Westgate, C., et al.[2023]

The Department of Veterans Affairs (VA) has successfully transitioned from long-term inpatient programs to a more effective and cost-efficient model of outpatient services for treating war-related PTSD, based on findings from multisite outcome studies.

Ongoing national performance monitoring has ensured the maintenance of specialized PTSD treatment capacity and improved access and quality of care, demonstrating that evidence-based practices can lead to better outcomes for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing patterns of care for war-related post-traumatic stress disorder at Department of Veterans Affairs medical centers: the use of performance data to guide program development. Rosenheck, R., Fontana, A.[2017]

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]

Measurement-based care (MBC) can help identify patients with posttraumatic stress disorder (PTSD) who are not responding to treatment as early as the sixth session, allowing for timely adjustments to their treatment plans.

In a study involving 2,182 patients from VA PTSD specialty clinics, session-by-session benchmarks were developed to visualize treatment progress using the PTSD Checklist (PCL-5), enhancing the potential for personalized, evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expected symptom change trajectories for the early identification of probable treatment nonresponse in VA PTSD specialty care clinics: A proof-of-concept. Darnell, BC., Benfer, N., Vannini, MBN., et al.[2023]

A meta-analysis of 48 randomized controlled trials (RCTs) on PTSD psychotherapy found no significant difference in treatment effects between trials that excluded participants with suicidal ideation (SI) and those that included them, indicating that SI exclusion does not notably affect outcomes.

This lack of significant impact suggests that clinical practice guidelines for PTSD treatments can be developed without the need for strict exclusion of individuals with SI, allowing for more inclusive research and potentially better treatment options for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis. Brooks, E., Spokas, M., Goldschmidt, D.[2022]

PTSD is prevalent among primary care patients and leads to significant functional and health issues, highlighting the need for effective treatment options within this setting.

Cognitive and behavioral therapies show the most promise as brief interventions for PTSD in primary care, but more research is needed to develop and validate these treatments specifically for this environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of intervention research for posttraumatic stress disorder within the primary care setting. Possemato, K.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Changing patterns of care for war-related post-traumatic stress disorder at Department of Veterans Affairs medical centers: the use of performance data to guide program development. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of Care for PTSD and Depression in the Military Health System: Final Report. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Expected symptom change trajectories for the early identification of probable treatment nonresponse in VA PTSD specialty care clinics: A proof-of-concept. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exclusion of Suicidal Participants From Randomized Controlled Trials for Posttraumatic Stress Disorder: A Meta-Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Development of the PTSD-Repository: A Publicly Available Repository of Randomized Controlled Trials for Posttraumatic Stress Disorder. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Medical service utilization by veterans seeking help for posttraumatic stress disorder. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Variation in health service use by veterans with an accepted disability of post-traumatic stress disorder who had a service record post 1975: a cluster analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The current state of intervention research for posttraumatic stress disorder within the primary care setting. [2021]