Combined Therapies for PTSD

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Melanie S Harned, PhD

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 8 9 10}

Research Team

Melanie S Harned, PhD

Principal Investigator

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

Eligibility 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

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.

Trial Timeline

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

Treatment Details

Interventions

• Dialectical Behavior Therapy (Behavioral Intervention)
• Dialectical Behavior Therapy Prolonged Exposure protocol (Behavioral Intervention)
• Prolonged Exposure therapy (Behavioral Intervention)
• Suicide risk management (Behavioral Intervention)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2020]

2. England 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. [2022]

3. United States 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Prolonged Exposure for PTSD in a Veteran group: a pilot effectiveness study. [2019]

5. England 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. [2021]

6. Netherlands 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of evidence-based psychotherapies for PTSD delivered in VA residential PTSD treatment. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A formative evaluation of two evidence-based psychotherapies for PTSD in VA residential treatment programs. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events. [2022]