Combined Therapies for PTSD
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Cognitive impairment, English proficiency, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a combined therapy for Veterans with PTSD at high risk for suicide. The treatment helps manage emotions and process trauma, aiming to reduce both PTSD symptoms and suicidal behaviors. This therapy has been shown to reduce suicidal thoughts and emotional instability among Veterans.
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's best to discuss this with the study team or your doctor.
What data supports the effectiveness of this treatment for PTSD?
Research shows that combining Dialectical Behavior Therapy (DBT) with the Prolonged Exposure (PE) protocol can significantly reduce PTSD symptoms, especially when compared to DBT alone. Additionally, PE therapy has been effective in reducing PTSD symptoms in veterans and emergency service personnel, indicating its broader applicability.
12345Is the combined therapy for PTSD safe for humans?
Research on Dialectical Behavior Therapy (DBT) and Prolonged Exposure (PE) therapy, including their combination, suggests they are generally safe for treating PTSD and related conditions. No significant safety concerns were reported in studies involving these therapies.
12367How is the Combined Therapies for PTSD treatment different from other treatments for PTSD?
The Combined Therapies for PTSD treatment is unique because it integrates Dialectical Behavior Therapy (DBT) with the Prolonged Exposure (PE) protocol, specifically targeting both behavioral issues and PTSD symptoms in a structured, stage-based approach. This combination aims to enhance the effectiveness of DBT by incorporating PE, which is a well-established method for reducing PTSD symptoms, offering a comprehensive treatment for individuals with complex conditions like borderline personality disorder and PTSD.
128910Eligibility Criteria
This trial is for Veterans with PTSD who are at risk of suicide. They must be eligible for VHA mental health care, have emotion dysregulation and recent self-harm, be over 18, willing to participate in all study activities, and currently have suicidal thoughts. Those already treated with DBT or PE recently, unable to stay safe on their own, planning to move away soon or unable to understand the study due to language or cognitive issues can't join.Inclusion Criteria
I am currently having thoughts about harming myself.
Recent and repeated self-directed violence
Emotion dysregulation
+4 more
Exclusion Criteria
I have been receiving DBT or PE therapy in the past year.
I will be available and not planning to move for the next 18 months.
I cannot ensure my own safety without help.
+1 more
Participant Groups
The trial tests if combining Dialectical Behavior Therapy (DBT) with a specific protocol called DBT Prolonged Exposure (PE) is more effective than just Prolonged Exposure therapy plus suicide risk management in reducing PTSD symptoms and suicidal behavior among Veterans.
2Treatment groups
Experimental Treatment
Active Control
Group I: DBT + DBT PEExperimental Treatment2 Interventions
This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD.
Group II: PE + SRMActive Control2 Interventions
This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).
Dialectical Behavior Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as DBT for:
- Borderline Personality Disorder
- Suicidal Behavior
- Emotional Dysregulation
🇪🇺 Approved in European Union as DBT for:
- Borderline Personality Disorder
- Suicidal Behavior
- Emotional Dysregulation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, WA
Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, MN
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
What changes when? The course of improvement during a stage-based treatment for suicidal and self-injuring women with borderline personality disorder and PTSD. [2020]Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol is an integrated treatment for suicidal and self-injuring individuals with PTSD and borderline personality disorder (BPD) that occurs in three stages: Stage 1 targets behavioral dyscontrol, Stage 2 targets posttraumatic stress disorder (PTSD) via the DBT PE protocol, and Stage 3 addresses remaining problems. We evaluated the course of change in multiple outcomes across these three stages and compared them to changes found in DBT alone.
Does Adding the Dialectical Behavior Therapy Prolonged Exposure (DBT PE) Protocol for PTSD to DBT Improve Outcomes in Public Mental Health Settings? A Pilot Nonrandomized Effectiveness Trial With Benchmarking. [2022]The Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol improves DBT's effects on PTSD in research settings, but its effectiveness in community settings is largely unknown. This pilot nonrandomized controlled trial examined DBT with and without DBT PE in four public mental health agencies. Patients (N = 35, 12-56 years old, 80.0% female, 64.7% racial/ethnic minorities, 44.1% sexual minorities) had PTSD, were receiving DBT, and completed assessments every four months over one year. Sixteen patients (45.7%) initiated DBT PE, 19 (54.3%) did not, and dropout did not differ between groups (31.3% vs. 26.3%). The primary barrier to initiating DBT PE was clinician turnover (57.9% of non-initiators). After adjusting for confounds, DBT PE initiators (g = 1.1) and completers (g = 1.4) showed a greater reduction in PTSD than patients who received DBT only (g = 0.5; p's
A preliminary examination of prolonged exposure therapy with Iraq and Afghanistan veterans with a diagnosis of posttraumatic stress disorder and mild to moderate traumatic brain injury. [2022]: Preliminary examination of the effectiveness of prolonged exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) with Operation Enduring Freedom and Operation Iraqi Freedom Veterans who have experienced traumatic brain injury (TBI).
Prolonged Exposure for PTSD in a Veteran group: a pilot effectiveness study. [2019]Previous research has consistently demonstrated that Prolonged Exposure (PE) therapy is an effective treatment for posttraumatic stress disorder (PTSD). Traditionally, PE has been studied and delivered on an individual basis. However, the growing number of Veterans in need of PTSD treatment has led to increased interest in group therapies as an efficient way to provide access to care. The current study examined a group and individual hybrid treatment that was developed based on PE principles. Treatment was 12 weeks in length and consisted of 12 one-hour group sessions focused on in vivo exposures, and an average of approximately five-hour long individual imaginal exposure sessions. Data for this study were derived from 67 veterans who participated in 12 cohorts of the Group PE. Significant reductions in PTSD and depression symptoms were found in both completers and intent-to-treat sample analyses. The clinical implications of these findings are discussed.
Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. [2021]Prolonged exposure (PE) therapy is an evidence-based psychological treatment of post-traumatic stress disorder (PTSD), yet uptake amongst practitioners is less than desirable. The aim of this study was to evaluate the efficacy of a PE training workshop plus intensive consultation programme to improve practitioners' self-efficacy and outcome expectations as well as uptake of PE for emergency service patients with PTSD.
Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial. [2023]Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-trauma focused treatment that may offer an alternative treatment for PTSD.
Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]Prolonged exposure (PE) therapy is the first-line treatment for posttraumatic stress disorder (PTSD) in combat veterans. The underlying brain changes of treatment effect in PTSD are currently unknown.
Comparative effectiveness of evidence-based psychotherapies for PTSD delivered in VA residential PTSD treatment. [2023]Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) are first-line treatments for posttraumatic stress disorder (PTSD). There have been few direct comparisons of CPT and PE intended to determine their comparative effectiveness, none of which have examined outcomes among military veterans receiving these treatments in a residential setting such as the Department of Veterans Affairs (VA) residential rehabilitation treatment programs (RRTPs). Such work is essential given that these veterans are among the most complex and severely symptomatic patients with PTSD treated in VA. In this study we compared changes in PTSD and depressive symptoms across admission, discharge, four months and 12 months following discharge among veterans who received CPT or PE within VA RRTPs.
A formative evaluation of two evidence-based psychotherapies for PTSD in VA residential treatment programs. [2021]Between July 2008 and March 2011, 38 U.S. Department of Veterans Affairs (VA) residential treatment programs for posttraumatic stress disorder (PTSD) participated in a formative evaluation of their programmatic services, including evidenced-based treatments (EBTs). Face-to-face qualitative interviews were conducted with over 250 staff by an independent psychologist along with onsite participant observations. This evaluation coincided with a national VA dissemination initiative to train providers in two EBTs for PTSD: prolonged exposure (PE) and cognitive processing therapy (CPT). A substantial proportion of eligible (based on professional background) residential treatment providers received training in PE (37.4%) or CPT (64.2%), with 9.5% completing case consultation or becoming national trainers in each therapy respectively. In semistructured interviews, providers reported that their clinical programs had adopted these EBTs at varying levels ranging from no adoption to every patient receiving the full protocol. Suggestions for improving the adoption of PE and CPT are noted, including distilling manualized treatments to essential common elements.
Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events. [2022]This pilot study investigated the feasibility of Prolonged Exposure (PE) treatment for Japanese patients with posttraumatic stress disorder (PTSD) due to mixed traumatic events. Among 12 participants in this study, 9 women and 1 man completed between 9 and 15 weekly individual PE sessions; 2 female participants dropped out in early sessions. Among completers, the authors identified a significant reduction of symptom severity scores from pretreatment to posttreatment in terms of PTSD and depression on therapist-rated and self-rated measurements. Symptom levels remained low in 3- and 6-month follow-up assessments. Our findings suggest that PE is feasible and can be accepted for PTSD patients not only in Western countries, but also for those in Japan.