Intensive Therapy for PTSD
Recruiting in Palo Alto (17 mi)
Overseen byStephanie Y Wells, PhD MS BA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group
Trial Summary
What is the purpose of this trial?Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).
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.
What data supports the idea that Intensive Therapy for PTSD is an effective treatment?
The available research shows that Intensive Therapy for PTSD, which includes treatments like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE), is effective for veterans with PTSD. Studies indicate that these therapies, when delivered individually, are more effective than when delivered in groups. This suggests that Intensive Therapy can significantly help reduce PTSD symptoms in real-world settings, especially when tailored to individual needs.
12345What safety data exists for intensive PTSD therapy?
The systematic review and case studies indicate that intensive treatments like Massed Prolonged Exposure (Massed-PE) and Cognitive Processing Therapy (CPT) have shown a large impact on reducing PTSD symptoms with high treatment completion rates and low dropout rates (0%-13.6%). These findings suggest that intensive therapy can be an effective and safe alternative to standard delivery, with reduced dropout rates and improved treatment response.
14678Eligibility Criteria
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.
+2 more
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
+1 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: EBP-MassedExperimental Treatment1 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-TAUActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Durham VA Medical Center, Durham, NCDurham, NC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effectiveness and comparative effectiveness of evidence-based psychotherapies for posttraumatic stress disorder in clinical practice. [2023]While evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD) is a first-line treatment, its real-world effectiveness is unknown. We compared cognitive processing therapy (CPT) and prolonged exposure (PE) each to an individual psychotherapy comparator group, and CPT to PE in a large national healthcare system.
Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. [2023]Cognitive processing therapy (CPT) and prolonged exposure (PE) delivered in an individual setting are efficacious and effective treatments for veterans with posttraumatic stress disorder (PTSD). Group CPT has been shown to be less efficacious than individual CPT, however, evidence regarding real-world effectiveness is limited.
Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. [2021]Despite availability of evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), not all veterans who initiate EBPs experience benefit. Better understanding factors associated with clinically significant improvement can help ameliorate care.
VA residential treatment providers' use of two evidence-based psychotherapies for PTSD: Global endorsement versus specific components. [2023]Despite a growing body of knowledge about the dissemination of evidence-based psychotherapies (EBPs), their actual use in clinical settings is not well understood. The purpose of the current study was to compare self-reported component use with global use for 2 EBPs for posttraumatic stress disorder (PTSD), prolonged exposure (PE), and cognitive processing therapy (CPT).
Sequence matters: Combining Prolonged Exposure and EMDR therapy for PTSD. [2020]Investigating the influence of the sequence in which two evidence-based trauma-focused treatments are offered to PTSD-patients.
World Trade Center: A longitudinal case study for treating Post Traumatic Stress Disorder with Emotional Freedom Technique and Eye Movement Desensitization and Reprocessing. [2019]Emotional Freedom Techniques (EFT) and Eye Movement Desensitization and Reprocessing (EMDR) have been empirically validated as effective psychotherapeutic interventions for treating Post Traumatic Stress Disorder (PTSD). This single subject design case study is of a survivor of the Twin Towers collapse who was treated for prolonged PTSD complicated by dissociated memories.
A Systematic Review of Intensive Empirically Supported Treatments for Posttraumatic Stress Disorder. [2021]Various clinical practice guidelines for the treatment of posttraumatic stress disorder (PTSD) have consistently identified two frontline evidence-based psychotherapies (EBPs)-prolonged exposure (PE) and cognitive processing therapy (CPT)-as well as other empirically supported treatments (EST), such as eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT for PTSD). However, researchers and clinicians continue to be concerned with rates of symptom improvement and patient dropout within these treatments. Recent attempts to address these issues have resulted in intensive, or "massed," treatments for PTSD. Due to variability among intensive treatments, including treatment delivery format, fidelity to the EST, and the population studied, we conducted a systematic review to summarize and integrate the literature on the impact of intensive treatments on PTSD symptoms. A review of four major databases, with no restrictions regarding publication date, yielded 11 studies that met all inclusion criteria. The individual study findings denoted a large impact of treatment on reduction of PTSD symptoms, ds = 1.15-2.93, and random-effects modeling revealed a large weighted mean effect of treatment, d = 1.57, 95% CI [1.24, 1.91]. Results from intensive treatments also noted high rates of treatment completion (i.e., 0%-13.6% dropout; 5.51% pooled dropout rate across studies). The findings suggest that intensive delivery of these treatments can be an effective alternative to standard delivery and contribute to improved treatment response and reduced treatment dropout.
Massed Prolonged Exposure for PTSD in Two Firefighters: Preliminary Case Study Findings. [2022]Military service members and first responders experience significant trauma exposure in the line of duty. Service members who transition to first-responder positions may be at an increased risk for developing PTSD due to the cumulative effects of trauma exposure. A common criticism of the standard delivery methods for most evidence-based treatments for PTSD is high dropout rates. Massed-prolonged exposure (Massed-PE) has been demonstrated to be efficacious and reduces dropouts by about 50%. This case study is the first of its kind to specifically assess the clinical utility of using Massed-PE to treat PTSD in two firefighters. Results from this case study indicate that both firefighters had significant reductions in their PTSD symptoms. Massed-PE may be an effective approach to treating PTSD in firefighters and may help overcome some of the barriers of conventional treatment delivery. Additional controlled research is needed to further evaluate this promising treatment approach in firefighter populations.
Management of high-risk prostate cancer: radiation therapy and hormonal therapy. [2013]The prognosis of high-risk prostate cancer is poor with a high mortality rate. The Radiation Therapy Oncology Group (RTOG) has performed dose-escalation studies of external beam radiation therapy (EBRT) and has developed high-precision radiation therapy (RT) methods such as intensity-modulated RT, carbon ion therapy, and proton beam therapy. High-dose rate brachytherapy (HDR-BT) is also studied as an option for high-risk prostate cancer treatment. Past clinical trials have suggested that the local control rate of high-risk prostate cancer improves with total EBRT dose, even for doses > 70 Gy. Several randomized controlled trials, including RTOG 94-06, have shown significantly better prognoses with higher doses (> 75 Gy) than with lower doses ( 2 years) HT combined with definitive RT. Further studies are warranted to elucidate optimal irradiation doses, HT treatment durations, and combination therapy schedules.
Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. [2021]External Beam Radiation Therapy (EBRT) is one of the option available for the treatment of clinically localized prostate cancer. In patients with radiorecurrent localized prostate cancer, Androgen Deprivation Therapy (ADT) is one of the most common therapeutic strategies. However, in the last decades, other salvage treatment options have been investigated, such as brachytherapy, cryoablation and High Intensity Focused Ultrasound (Hifu).
Combining radiotherapy and focused ultrasound for pain palliation of cancer induced bone pain; a stage I/IIa study according to the IDEAL framework. [2022]Cancer induced bone pain (CIBP) strongly interferes with patient's quality of life. Currently, the standard of care includes external beam radiotherapy (EBRT), resulting in pain relief in approximately 60% of patients. Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) is a promising treatment modality for CIBP.
Long-term outcomes of definitive external-beam radiotherapy for non-metastatic castration-resistant prostate cancer. [2022]Although definitive external-beam radiotherapy (EBRT) is one of the treatment options for non-metastatic castration-resistant prostate cancer (NM-CRPC), there are limited data on the long-term outcomes of this treatment.
A review of pre-hospital case series among those with time to double external defibrillation and neurologic outcomes. [2021]Double external defibrillation (DED) has been used as a final effort to terminate refractory ventricular fibrillation/pulseless ventricular tachycardiac (rVF/pVT). Data surrounding time to DED and patient-centered outcomes remains limited.