Combined Therapies for PTSD

Recruiting at 2 trial locations

Overseen By John C Fortney, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, English proficiency, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 months for DBT + DBT PE, up to 18 sessions for PE + SRM

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for PTSD (Posttraumatic Stress Disorder) in Veterans at high risk of suicide. It compares a combined therapy approach using Dialectical Behavior Therapy (DBT) and a specialized Prolonged Exposure protocol (DBT PE) with the current standard treatment, which includes Prolonged Exposure therapy and suicide risk management. The researchers aim to determine if the combined therapy more effectively improves PTSD symptoms and reduces suicide risk. Veterans with PTSD who struggle with emotional control and have recently experienced suicidal thoughts or actions may be suitable for this study. The results will inform treatment guidelines for Veterans facing these challenges. As an unphased trial, this study offers Veterans the chance to contribute to groundbreaking research that could enhance future PTSD treatments.

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.

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

Research has shown that combining Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol is generally safe for treating PTSD. Studies indicate that this treatment improves symptoms without causing major side effects. Specifically, one study found that individuals who completed the DBT PE protocol were much less likely to attempt suicide or self-harm compared to those who only received standard DBT.

Prolonged Exposure therapy (PE) with suicide risk management (SRM) is another well-established treatment for PTSD. It is considered safe and effective in reducing trauma symptoms. Research also shows that PE decreases thoughts and actions related to suicide, making it a reliable option for those with PTSD, especially when combined with SRM.

Both treatments have strong support from studies, which suggest they are well-tolerated and effective in improving PTSD symptoms and reducing the risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these combined therapies for PTSD because they're testing unique approaches to tackle the condition. Unlike standard treatments that often use one type of therapy, this trial combines Dialectical Behavior Therapy (DBT) with a specialized Prolonged Exposure protocol (DBT PE) for a comprehensive approach. Another treatment arm in the study uses Prolonged Exposure therapy enhanced with suicide risk management, which brings a dual focus on trauma and immediate safety. These innovative combinations aim to enhance treatment effectiveness by addressing both emotional regulation and trauma exposure, offering new hope for those with PTSD.

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

Research shows that combining Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) effectively treats PTSD. Studies have found that DBT PE can significantly reduce PTSD symptoms and improve patients' quality of life. One study showed that 58% of patients experienced symptom remission compared to 41% with other treatments. In this trial, one group of participants will receive the combination of DBT and DBT PE.

Another group will receive Prolonged Exposure therapy (PE) combined with suicide risk management (SRM). Research indicates that this combination effectively reduces PTSD symptoms and suicidal thoughts. Success rates for PE range from 65% to 80%, highlighting its effectiveness. Both approaches have strong evidence supporting their ability to improve PTSD outcomes. ^{1 2 3 5 6}

Who Is on the Research Team?

Melanie S Harned, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DBT + DBT PE or PE + SRM for PTSD and suicide risk management

12 months for DBT + DBT PE, up to 18 sessions for PE + SRM

Regular outpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

5 assessment points

Implementation Evaluation

Evaluation of barriers and facilitators to implementation of treatments

Concurrent with treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavior Therapy
• Dialectical Behavior Therapy Prolonged Exposure protocol
• Prolonged Exposure therapy
• Suicide risk management

Trial Overview 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.

How Is the Trial Designed?

Group I: DBT + DBT PE Experimental Treatment 2 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 + SRM Active Control 2 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

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

In a study of 31 combat veterans with PTSD undergoing prolonged exposure therapy, 9 out of 24 completers achieved complete remission from PTSD, indicating the therapy's potential efficacy.

The study found that successful remission from PTSD was associated with decreased activation in the left anterior insula during negative image anticipation and increased connectivity with other brain regions, suggesting that effective treatment may involve better regulation of anticipatory anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. Simmons, AN., Norman, SB., Spadoni, AD., et al.[2021]

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]

In a study of 38 women with borderline personality disorder (BPD) and PTSD, adding the DBT Prolonged Exposure (DBT PE) protocol to standard Dialectical Behavior Therapy (DBT) significantly improved PTSD symptoms during Stage 2 and enhanced overall well-being in Stage 3.

The results suggest that targeting PTSD directly is crucial for improving related issues, as changes in other problems like BPD and dissociation occurred only after PTSD treatment, indicating that DBT PE is a beneficial addition to standard DBT for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What changes when? The course of improvement during a stage-based treatment for suicidal and self-injuring women with borderline personality disorder and PTSD. Harned, MS., Gallop, RJ., Valenstein-Mah, HR.[2020]

A hybrid treatment combining group and individual Prolonged Exposure (PE) therapy was effective in reducing PTSD and depression symptoms in veterans, based on a 12-week program involving 67 participants across 12 cohorts.

Both completers and those analyzed by intent-to-treat showed significant symptom reductions, highlighting the potential of group therapies to efficiently provide care for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Exposure for PTSD in a Veteran group: a pilot effectiveness study. Smith, ER., Porter, KE., Messina, MG., et al.[2019]

In a study of 1130 veterans with PTSD treated in VA residential programs, both Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) showed significant reductions in PTSD and depressive symptoms over 12 months, with no significant differences between the two therapies.

Both CPT and PE resulted in large effect sizes for symptom reduction (PTSD: CPT d = 1.41, PE d = 1.51; Depression: CPT d = 1.01, PE d = 1.09), indicating that either treatment is effective for this complex population of veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of evidence-based psychotherapies for PTSD delivered in VA residential PTSD treatment. Sippel, LM., Gross, GM., Spiller, TR., et al.[2023]

Prolonged exposure (PE) therapy was found to be effective in reducing PTSD and depression symptoms in a small group of 10 Veterans with mild to moderate traumatic brain injury (TBI) and chronic PTSD, showing large effect sizes from pre- to posttreatment.

The therapy was safely adapted for Veterans with cognitive impairments, indicating that PE can be a viable treatment option for this population, with significant symptom improvements observed after 8 to 18 sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wolf, GK., Strom, TQ., Kehle, SM., et al.[2022]

In a pilot study involving 35 patients with PTSD receiving Dialectical Behavior Therapy (DBT), those who initiated the DBT Prolonged Exposure (PE) protocol showed significantly greater reductions in PTSD symptoms compared to those who received DBT alone, with effect sizes of 1.1 for initiators and 1.4 for completers.

The study found no increase in self-injurious behavior or crisis service use among patients receiving DBT PE, indicating that this intervention is safe and can be effectively implemented in community mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Harned, MS., Schmidt, SC., Korslund, KE., et al.[2022]

Prolonged Exposure (PE) therapy was found to be feasible and well-accepted among Japanese patients with PTSD, with 10 out of 12 participants completing the treatment over 9 to 15 sessions.

Participants showed significant reductions in PTSD and depression symptoms from before treatment to after, with these improvements maintained at 3- and 6-month follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events. Asukai, N., Saito, A., Tsuruta, N., et al.[2022]

The IMPACT trial will assess the effectiveness of the Unified Protocol (UP) compared to Prolonged Exposure (PE) therapy in treating PTSD, involving 120 adult participants over 10 sessions, aiming to determine if UP is as effective as PE.

This study is significant as it explores a non-trauma focused approach (UP) for PTSD, potentially offering an alternative for individuals who do not respond to traditional trauma-focused therapies like PE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lau, W., Chisholm, K., Gallagher, MW., et al.[2023]

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8124086/

Does Adding the Dialectical Behavior Therapy Prolonged ... Although these studies suggest that adding the DBT PE protocol to DBT is feasible, safe, and likely to improve PTSD and other outcomes, the generalizability of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11445934/

A systematic review and meta-analysis on the efficacy of ... Conclusions: Based on the results of our meta-analysis, DBT-PTSD and DBT PE were effective in reducing PTSD symptom severity and comorbid ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722925000069

Dialectical Behavior Therapy Prolonged Exposure (DBT ... DBT PE improved quality of life, life worth living, radical acceptance of trauma. •. Evidence-based protocols can benefit from a minority stress ...

4. dbtpe.org dbtpe.org/research

Research Perspectives on a stage-based treatment for posttraumatic stress disorder among Dialectical Behavior Therapy consumers in public mental health settings.

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2768029

Dialectical Behavior Therapy for Posttraumatic Stress ... The proportions achieving symptomatic remission were 58% in DBT-PTSD vs 41% in CPT, a significant difference. Meaning In this trial, patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3987949/

A pilot randomized controlled trial of Dialectical Behavior ... Patients who completed the DBT PE protocol were 2.4 times less likely to attempt suicide and 1.5 times less likely to self-injure than those in DBT. Among ...