Intensive Therapy for PTSD

Overseen By Laurel B Koss, MS OTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: High suicide risk, Manic, Psychotic, others

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

Compensation: Varies

Number of Visits: 3

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a more intensive therapy schedule can help Veterans with PTSD adhere to their treatment and improve their well-being. It compares traditional weekly therapy sessions to a more frequent schedule, occurring three or more times a week over about a month. Veterans with PTSD who have chosen specific therapies, such as cognitive processing therapy or prolonged exposure (both part of Evidence-Based Psychotherapy - Massed, or EBP-Massed), may be suitable for this study. The goal is to assess whether the more intense schedule enhances therapy retention and outcomes. As an unphased trial, this study provides Veterans the opportunity to explore potentially more effective therapy schedules before they become widely available.

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 mainly focuses on your PTSD treatment plan and any concurrent trauma-focused treatments you might be receiving.

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

The 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 intensive therapy sessions for PTSD, like the one being studied, are generally safe and well-tolerated. Studies have found that these treatments often result in low dropout rates and significant improvements in PTSD symptoms. This indicates that participants can handle the therapy sessions without many problems.

Reports of negative effects or safety issues with these intensive therapy formats are rare. Even with therapy administered more frequently—three times a week or more—the risk of side effects does not increase, nor does it lead to early treatment discontinuation. Overall, evidence supports the safety of intensive therapies for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they explore new ways of delivering evidence-based psychotherapies. Unlike the standard treatment, which typically involves weekly sessions, EBP-Massed delivers therapy at least three times a week. This more intensive approach could potentially lead to faster and more significant improvements in symptoms. Meanwhile, EBP-TAU, the active comparator, maintains the usual once-a-week therapy schedule, providing a direct comparison to gauge the effectiveness of the massed format. This trial could reshape how therapy is structured for PTSD, offering more rapid relief for those in need.

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

Research shows that intensive, evidence-based therapies for PTSD, such as those in the EBP-Massed arm of this trial with multiple weekly sessions, are promising. These therapies have low dropout rates and significantly improve symptoms. Studies suggest that more frequent sessions help patients remain in treatment longer.

In the EBP-TAU arm of this trial, therapies like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) are delivered as treatment as usual, typically once a week, and effectively reduce PTSD symptoms in veterans.

Both methods have research support, but the more frequent sessions in the EBP-Massed arm might help more people complete their therapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephanie Y Wells, PhD MS BA

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD. Participants must be diagnosed with PTSD or a related traumatic stress disorder and are seeking treatment within the VHA system. The study aims to improve how often patients stay in therapy until it's finished.

Inclusion Criteria

I am willing to be assigned to any treatment group in the study.

Meets criteria for current PTSD

I've decided to undergo CPT or PE therapy after consulting with a Durham Trauma Recovery Program clinic provider.

Exclusion Criteria

I am at a high risk of attempting suicide.

I am currently receiving a specific treatment for PTSD.

Active manic symptoms that would likely interfere with treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PTSD evidence-based psychotherapies in either a massed format or treatment as usual

20 weeks

3 or more visits per week for massed format, 1 visit per week for treatment as usual

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EBP-Massed
• EBP-TAU

Trial Overview

The study tests two ways of scheduling PTSD treatments: EBP-Massed (intense, several days per week for about a month) versus EBP-TAU (the usual, typically once a week). It wants to see if massed treatment helps more people complete their therapy.

How Is the Trial Designed?

Group I: EBP-Massed Experimental Treatment 1 Intervention

PTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week).

Group II: EBP-TAU Active Control 1 Intervention

PTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week.

EBP-Massed is already approved in United States for the following indications:

Approved in United States as Evidence-Based Psychotherapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The combination of external beam radiotherapy (EBRT) and magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) for treating cancer-induced bone pain (CIBP) was found to be safe and feasible in a small study of six patients, with no serious adverse events reported.

Five out of six patients experienced pain relief within a week after the combined treatment, and this response stabilized at 60% by the four-week follow-up, suggesting that this approach may enhance pain management for patients with bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining radiotherapy and focused ultrasound for pain palliation of cancer induced bone pain; a stage I/IIa study according to the IDEAL framework. Bartels, MMTJ., Verpalen, IM., Ferrer, CJ., et al.[2022]

In a study of 31 patients with non-metastatic castration-resistant prostate cancer treated with definitive external-beam radiotherapy (EBRT), the 5-year overall survival rate was 74.6%, indicating that EBRT can lead to favorable long-term survival outcomes.

The treatment resulted in a local relapse-free survival rate of 91% at both 5 and 8 years, suggesting that EBRT is effective in preventing local recurrence of the cancer, although about one-third of patients experienced disease recurrence within 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of definitive external-beam radiotherapy for non-metastatic castration-resistant prostate cancer. Aizawa, R., Takayama, K., Nakamura, K., et al.[2022]

Intensive treatments for PTSD, such as prolonged exposure and cognitive processing therapy, have shown a large effect on reducing symptoms, with effect sizes ranging from 1.15 to 2.93, and a weighted mean effect of 1.57 based on 11 studies.

These intensive treatments also resulted in high completion rates, with dropout rates as low as 0% to 13.6%, suggesting that they may be more effective and engaging for patients compared to standard treatment delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Intensive Empirically Supported Treatments for Posttraumatic Stress Disorder. Sciarrino, NA., Warnecke, AJ., Teng, EJ.[2021]

In a study of 265,566 veterans with PTSD, completing 8 or more sessions of cognitive processing therapy (CPT) led to a 6.4-point improvement in PTSD symptoms, while prolonged exposure (PE) therapy resulted in a 9.7-point improvement, indicating both therapies are effective but PE may offer slightly better outcomes.

Both CPT and PE showed similar and modest improvements in PTSD symptoms compared to non-evidence-based psychotherapies, highlighting the need for ongoing research to enhance PTSD treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and comparative effectiveness of evidence-based psychotherapies for posttraumatic stress disorder in clinical practice. Maguen, S., Madden, E., Holder, N., et al.[2023]

In a review of 29 cases, patients who received double external defibrillation (DED) within 30 minutes of cardiac collapse had significantly better survival rates (33.3%) compared to those treated after 30 minutes (7.1%).

Overall, only 20.6% of patients survived to discharge, with 13.8% achieving neurologically intact survival, indicating that while early DED may improve outcomes, the evidence is still insufficient to draw definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of pre-hospital case series among those with time to double external defibrillation and neurologic outcomes. Miraglia, D., Alonso, W.[2021]

Women veterans and those who started evidence-based psychotherapy (EBP) within a year of seeking mental health care had higher chances of improving their PTSD symptoms, indicating the importance of timely intervention.

Completing at least 8 sessions of EBP and receiving specific therapies like Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) individually were linked to better outcomes, suggesting that both the timing and type of treatment can significantly influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. Maguen, S., Holder, N., Li, Y., et al.[2021]

In a study involving 106 PTSD patients undergoing an eight-day treatment program, those who received Prolonged Exposure (PE) therapy first followed by EMDR therapy experienced a significantly greater reduction in PTSD symptoms compared to those who had the reverse sequence.

Patients preferred the PE-first sequence, finding it more helpful, which suggests that the order of trauma-focused treatments can impact both efficacy and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequence matters: Combining Prolonged Exposure and EMDR therapy for PTSD. Van Minnen, A., Voorendonk, EM., Rozendaal, L., et al.[2020]

A formative evaluation of 38 VA residential treatment programs for PTSD revealed that a significant number of providers received training in evidence-based treatments (EBTs) for PTSD, with 37.4% trained in prolonged exposure (PE) and 64.2% in cognitive processing therapy (CPT).

The adoption of these EBTs varied widely among programs, indicating a need for strategies to enhance implementation, such as simplifying treatment manuals to focus on essential elements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A formative evaluation of two evidence-based psychotherapies for PTSD in VA residential treatment programs. Cook, JM., O'Donnell, C., Dinnen, S., et al.[2021]

A single session of Emotional Freedom Techniques (EFT) combined with Eye Movement Desensitization and Reprocessing (EMDR) led to significant improvements in PTSD symptoms for a survivor of the Twin Towers collapse, as measured by the Trauma Symptom Inventory (TSI) and Personality Assessment Inventory (PAI).

The participant experienced nearly complete symptom relief and was able to return to work after years of disability, highlighting the potential efficacy of combining these therapeutic approaches for treating complex PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World Trade Center: A longitudinal case study for treating Post Traumatic Stress Disorder with Emotional Freedom Technique and Eye Movement Desensitization and Reprocessing. Nicosia, GJ., Minewiser, L., Freger, A.[2019]

Higher doses of external beam radiation therapy (EBRT) greater than 75 Gy significantly improve prognosis in high-risk prostate cancer patients, as shown in multiple randomized controlled trials including RTOG 94-06.

Carbon ion therapy has demonstrated promising biochemical recurrence-free survival rates in high-risk prostate cancer patients, indicating that particle therapy is a valid treatment option alongside traditional radiation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of high-risk prostate cancer: radiation therapy and hormonal therapy. Nomiya, T., Tsuji, H., Toyama, S., et al.[2013]

A study involving 174 providers from 38 VA PTSD residential treatment programs found that while many frequently used evidence-based psychotherapies (EBPs) like prolonged exposure (PE) and cognitive processing therapy (CPT), there was a notable discrepancy between self-reported component use and overall treatment use.

Some providers reported using PE and CPT often but did not consistently implement key components of these therapies, suggesting that flexibility in treatment delivery may be necessary while still maintaining fidelity to the core principles of these EBPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VA residential treatment providers' use of two evidence-based psychotherapies for PTSD: Global endorsement versus specific components. Thompson, R., Simiola, V., Schnurr, PP., et al.[2023]

A review of 1241 patients treated with High Intensity Focused Ultrasound (Hifu) for radiorecurrent localized prostate cancer showed an overall survival rate of 85.2% at 5 years, indicating its effectiveness as a salvage treatment after External Beam Radiation Therapy (EBRT) failure.

The study analyzed patients with a mean age of 68.6 years and a PSA level of 5.87 ng/mL before treatment, with a follow-up period averaging 24.3 months, highlighting the potential of Hifu as a viable option for patients who do not respond to initial radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. Maestroni, U., Tafuri, A., Dinale, F., et al.[2021]

Massed-prolonged exposure (Massed-PE) therapy has shown significant efficacy in reducing PTSD symptoms in two firefighters, suggesting it may be a beneficial treatment for this population.

This approach also appears to lower dropout rates by about 50%, addressing a common issue with traditional PTSD treatments, but further controlled studies are needed to confirm its effectiveness in larger firefighter groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massed Prolonged Exposure for PTSD in Two Firefighters: Preliminary Case Study Findings. Zwetzig, SE., Koch, LM., Blount, TH., et al.[2022]

In a study of 6735 veterans, those receiving individual cognitive processing therapy (CPT) showed a statistically greater reduction in PTSD symptoms at discharge compared to those in group CPT, although the difference was less than the clinically important threshold.

By the 4-month follow-up, there were no significant differences in PTSD symptom severity between the group and individual therapy participants, suggesting that both treatment formats may ultimately lead to similar long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. Spiller, TR., Duek, O., Buta, E., et al.[2023]

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