Dialectical Behavior Therapy for Psychosocial Functioning in Veterans

Recruiting at 1 trial location

Overseen By Emily R Edwards, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Limited English, Group therapy intolerance, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a therapy program called DBT-J designed to help veterans with legal troubles and mental health issues. The program aims to reduce future criminal behavior and improve overall well-being. Veterans will participate in either DBT-J or another type of group therapy. Dialectical Behavior Therapy (DBT) has been adapted for various populations, including justice-involved veterans, to address specific needs and improve outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Dialectical Behavior Therapy for Justice-Involved Veterans?

Research shows that Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) led to improvements in areas like psychological distress, substance use, and quality of life for veterans involved with the justice system. These positive changes were maintained even one month after treatment, suggesting the therapy's potential usefulness. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy (DBT) safe for veterans?

Research on Dialectical Behavior Therapy (DBT) for veterans, including those involved with the justice system, suggests it is generally safe and well-accepted. Studies have shown high participant attendance and retention, indicating that veterans find the therapy acceptable and manageable. ^{2 3 4 5 6}

How is Dialectical Behavior Therapy for Justice-Involved Veterans different from other treatments for veterans?

Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is unique because it combines cognitive-behavioral techniques with mindfulness and emotional regulation skills specifically tailored for veterans who have been involved with the justice system, focusing on improving psychosocial functioning and reducing problematic behaviors. ^{7 8 9 10 11}

Research Team

Emily R Edwards, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

This trial is for Veterans aged 18 or older who can consent and have had recent run-ins with the law, like an arrest or probation within the last two years. It's not for those in other trials, non-English speakers, enrolled in similar therapy programs, previous DBT-J participants, or those who can't handle group therapy.

Inclusion Criteria

Current or recent history of criminal justice involvement, defined as (a) criminal arrest, order of protection, or incarceration within two years prior to participation and/or (b) supervision by probation or parole at the time of participation

I am a veteran and I am 18 years old or older.

Able to provide consent

Exclusion Criteria

Limited English proficiency

Enrollment in a concurrent clinical trial

Prior participation in a DBT-J program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans or supportive group psychotherapy

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 weeks

Treatment Details

Interventions

• Dialectical Behavior Therapy for Justice-Involved Veterans
• Supportive Group Psychotherapy for Justice-Involved Veterans

Trial Overview The study tests if Dialectical Behavior Therapy tailored for justice-involved Veterans (DBT-J) is better than supportive group therapy at reducing future criminal behavior and improving how well they function day-to-day. The trial also looks into how it affects other treatment goals and its long-term impact on different types of Veterans.

Participant Groups

Group I: Dialectical Behavior Therapy for Justice-Involved Veterans Experimental Treatment 1 Intervention

16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans

Group II: Supportive Group Psychotherapy Active Control 1 Intervention

16 weeks of supportive group psychotherapy for justice-involved Veterans

Dialectical Behavior Therapy for Justice-Involved Veterans is already approved in United States for the following indications:

Approved in United States as DBT-J for:

• Mental health needs
• Substance use disorders
• Case management needs
• Legal needs
• Criminogenic risk reduction

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The article argues that treating complex trauma-related issues effectively may require using theoretical frameworks and individualized assessments, especially when there are no established treatments available.

Dialectical Behavior Therapy (DBT) is highlighted as a useful approach for addressing diverse and complicated trauma-related problems, supported by two case studies demonstrating its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of dialectical behavior therapy to the treatment of complex trauma-related problems: when one case formulation does not fit all. Wagner, AW., Rizvi, SL., Harned, MS.[2007]

Veterans with Borderline Personality Disorder who completed at least 6 months of Dialectical Behavior Therapy (DBT) showed a significant reduction in mental health service utilization, including a 50% decrease in psychiatric hospitalizations and shorter hospital stays.

The implementation of DBT led to a notable reduction in direct healthcare costs for veterans, suggesting that DBT not only improves mental health outcomes but also reduces the financial burden on the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veterans' service utilization and associated costs following participation in dialectical behavior therapy: a preliminary investigation. Meyers, LL., Landes, SJ., Thuras, P.[2022]

Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) was shown to be an acceptable and feasible intervention for addressing complex needs in 20 veterans, leading to significant improvements in criminogenic risk, psychological distress, substance use, and quality of life from pre- to post-treatment.

The positive changes observed in participants were largely maintained at a 1-month follow-up, highlighting the potential effectiveness of DBT-J and the importance of further research into its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for justice-involved veterans: Changes in treatment targets in a small, pre-post design clinical trial. Edwards, ER., Epshteyn, G., Snyder, S., et al.[2023]

The study evaluated a 16-week dialectical behavior therapy program (DBT-J) for justice-involved veterans, showing high acceptability and feasibility with successful recruitment and strong participant retention among the 13 enrolled veterans.

Preliminary results indicated that veterans who completed DBT-J experienced reductions in criminogenic risk, suggesting that this therapy could effectively address the complex needs of this high-risk group within the Veterans Health Administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for justice-involved veterans (DBT-J): Feasibility and acceptability. Edwards, ER., Dichiara, A., Epshteyn, G., et al.[2023]

Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) was found to be an acceptable and feasible intervention for addressing the complex needs of 20 justice-involved veterans, showing significant improvements in criminogenic risk, psychological distress, substance use, case management needs, and quality of life from pre- to post-treatment.

The positive changes observed in participants were largely maintained at a 1-month follow-up, highlighting the potential effectiveness of DBT-J and the importance of further research into its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to Edwards et al. (2023). [2023]

Dialectical behavior therapy (DBT) was effective in reducing exclusionary behaviors in 51 women with borderline personality disorder (BPD), allowing 50-68% of those with PTSD to become eligible for PTSD treatment after one year.

Clients with more severe PTSD and a higher number of recent suicide attempts were less likely to qualify for PTSD treatment after DBT, highlighting the need for tailored interventions for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy as a precursor to PTSD treatment for suicidal and/or self-injuring women with borderline personality disorder. Harned, MS., Jackson, SC., Comtois, KA., et al.[2018]

Intradiverticular bladder tumors (IDBT) are rare, primarily affecting men (85%) with a mean diagnosis age of 64.81 years, and the most common symptom is gross hematuria (60.88%).

Cystoscopy is the preferred diagnostic method, and radical cystectomy is the main treatment option due to the high-grade histology of most tumors; however, transurethral resection (TURBT) is suitable for patients with low-grade tumors or those unfit for major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and management of intradiverticular bladder tumours: A pooled analysis of 498 cases. Katsimperis, S., Tzelves, L., Bellos, T., et al.[2023]

There is a significant need for new treatments for patients with BCG-unresponsive bladder cancer due to high risks of cancer recurrence and limited options after BCG therapy.

Immunotherapies, particularly indoleamine-2,3-dioxygenase inhibitors, are being actively researched as potential salvage therapies for non-muscle invasive bladder cancer, offering both biological and clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Indoleamine-2,3-Dioxygenase Inhibitors in Salvage Therapy for Non-Muscle Invasive Bladder Cancer. Chu, CE., Porten, SP., Grossfeld, GD., et al.[2020]

Recent clinical trials show that immunotherapies, including PD-L1/PD-1 inhibitors and CTLA-4 inhibitors, are promising for improving treatment outcomes in high-risk non-muscle invasive bladder cancer, with ongoing studies to further validate their efficacy.

While BCG remains a primary treatment, there is potential for it to be combined with newer immunomodulatory therapies to enhance effectiveness, indicating a shift in treatment strategies for bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of High Risk Non-Muscle Invasive Bladder Cancer. Ahdoot, M., Theodorescu, D.[2021]

The study developed lipid-polymer hybrid nanoparticles (LPNs) that co-encapsulate docetaxel (DTX) and curcumin (CUR), showing a particle size of 169.6 nm and a positive zeta potential of 35.7 mV, which are optimal for drug delivery.

In both in vitro and in vivo tests, the DTX-CUR-LPNs demonstrated significantly higher cytotoxicity against prostate cancer cells and more effective tumor growth inhibition in mice compared to other treatments, without causing noticeable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted nanomedicine for prostate cancer therapy: docetaxel and curcumin co-encapsulated lipid-polymer hybrid nanoparticles for the enhanced anti-tumor activity in vitro and in vivo. Yan, J., Wang, Y., Zhang, X., et al.[2022]

Bacillus Calmette-Guérin (BCG) is an effective immunotherapy for treating nonmuscle-invasive urothelial carcinoma, but about 30% of patients may still progress to more severe muscle-invasive disease.

Research is ongoing to enhance the immune response against urothelial carcinoma through various innovative therapies, including recombinant BCG, nonlive Mycobacterium agents, and adoptive T-cell therapies, aiming to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving immunotherapy strategies in urothelial cancer. Brancato, SJ., Lewi, K., Agarwal, PK.[2019]

References

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

Applications of dialectical behavior therapy to the treatment of complex trauma-related problems: when one case formulation does not fit all. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Veterans' service utilization and associated costs following participation in dialectical behavior therapy: a preliminary investigation. [2022]

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

Dialectical behavior therapy for justice-involved veterans: Changes in treatment targets in a small, pre-post design clinical trial. [2023]

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

Dialectical behavior therapy for justice-involved veterans (DBT-J): Feasibility and acceptability. [2023]

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

Correction to Edwards et al. (2023). [2023]

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

Dialectical behavior therapy as a precursor to PTSD treatment for suicidal and/or self-injuring women with borderline personality disorder. [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Diagnosis and management of intradiverticular bladder tumours: A pooled analysis of 498 cases. [2023]

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

Role of Indoleamine-2,3-Dioxygenase Inhibitors in Salvage Therapy for Non-Muscle Invasive Bladder Cancer. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Immunotherapy of High Risk Non-Muscle Invasive Bladder Cancer. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Targeted nanomedicine for prostate cancer therapy: docetaxel and curcumin co-encapsulated lipid-polymer hybrid nanoparticles for the enhanced anti-tumor activity in vitro and in vivo. [2022]

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

Evolving immunotherapy strategies in urothelial cancer. [2019]