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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help Veterans with PTSD (post-traumatic stress disorder) begin effective treatments like cognitive processing therapy (CPT) or prolonged exposure therapy (PE). Researchers are testing a new health services approach, the New Health Services Intervention, to determine if it better prepares Veterans for these therapies compared to standard care, known as Treatment As Usual. The goal is to facilitate Veterans in starting and maintaining these recommended treatments. Veterans diagnosed with PTSD at the San Francisco Veterans Affairs Medical Center who seek better treatment options might be suitable for this study. As an unphased trial, this study offers Veterans the chance to contribute to innovative research that could enhance PTSD treatment approaches.

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.

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

Research shows that psychological treatments for PTSD, such as the new health services program under study, are very safe. A review of different studies found these treatments to be safe, addressing some common misunderstandings. The studies showed that these programs can effectively reduce PTSD symptoms without causing significant harm. This specific program aims to help Veterans begin important PTSD treatments more easily, and evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the New Health Services Intervention for PTSD because it introduces a novel approach to treating the condition. Unlike the standard treatment options, which often focus on medication and traditional therapy, this intervention emphasizes a comprehensive health services strategy with a VA mental health treatment coordinator. This approach aims to provide more personalized, coordinated care, potentially improving outcomes by addressing the broader health needs of veterans with PTSD. By integrating various aspects of mental health care, this intervention could offer a more holistic and effective solution for those struggling with PTSD.

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

Research has shown that psychological treatments effectively treat PTSD. Studies have found that cognitive-behavioral therapy (CBT), a type of psychological treatment, greatly reduces PTSD symptoms compared to standard care. Evidence also suggests that these treatments work well in everyday situations. In this trial, participants will join one of two groups: the New Health Services Intervention or Treatment As Usual. This new health services approach aims to help more Veterans begin effective PTSD treatments like cognitive processing therapy (CPT) or prolonged exposure therapy (PE). ^{3 6 7 8 9}

Who Is on the Research Team?

Nicholas Holder, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2215036623003735/pdf

The efficacy of psychological interventions for adult post ... This meta-analysis reports strong evidence for the notion that psychological interventions are highly effective in treating not just patients with PTSD caused ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12341736/

Efficacy of interventions for posttraumatic stress disorder ... The CBT group (n = 12) had significantly greater reductions in PTSD symptoms than those in the usual care group (n = 19) from baseline to 12-month follow-up, as ...

3. nature.com nature.com/articles/s41598-024-83144-6

Real-world evaluation of an evidence-based telemental ... This evaluation suggests BCT for PTSD symptoms can be beneficial in real-world settings. Future research should perform large-scale evaluations.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672952/

A Review of PTSD and Current Treatment Strategies - PMC Current treatment strategies for control of trauma-associated symptoms of Post Traumatic Stress Disorder (PTSD) have recently been updated.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06691347

Effectiveness of Trauma Treatment in the Specialist Health ... The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9701019/

Psychological interventions for post-traumatic stress injuries ... The included RCTs evidenced reduced PTSD symptom severity at the completion of intervention (d = − 1.23; 95% CI − 1.81, − 0.65; 7 studies; I2 = 81%) and in ...

7. who.int who.int/news-room/fact-sheets/detail/post-traumatic-stress-disorder

Post-traumatic stress disorder The psychological interventions with the most evidence for effective treatment of PTSD are those based on cognitive behavioural therapy with a ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/17437199.2025.2526666

Efficacy of interventions for posttraumatic stress disorder ... This systematic review evaluated the efficacy of interventions for medically induced PTSD. Nine electronic databases were searched from inception to November ...

9. nimh.nih.gov nimh.nih.gov/news/science-updates/post-traumatic-stress-disorder-ptsd

Science Updates About Post-Traumatic Stress Disorder (PTSD) In an NIMH-funded study, a comprehensive collaborative care intervention significantly reduced post-traumatic stress disorder (PTSD) symptoms among trauma ...