Dialectical Behavior Therapy for Psychosocial Functioning in Veterans

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of therapy called Dialectical Behavior Therapy, designed to help veterans involved with the criminal justice system. The goal is to determine if this therapy can more effectively reduce the risk of future criminal behavior and improve overall life functioning compared to regular supportive group therapy. Veterans with recent legal troubles or those on probation or parole might be suitable candidates for this trial. As an unphased trial, it offers veterans a unique opportunity to explore innovative therapy options that could significantly enhance their quality of life.

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.

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

Research has shown that Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is generally safe and well-received. In past studies, veterans reported finding the program acceptable and noticed improvements in targeted areas. The program was easy to set up and attracted many participants, indicating that they found it manageable and helpful. Although more research is needed to fully understand its long-term effects, current evidence supports its safety and potential benefits for veterans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Dialectical Behavior Therapy (DBT) for justice-involved veterans because it specifically targets the unique challenges faced by veterans who have had legal issues. Unlike standard therapies, which might focus broadly on mental health, DBT combines cognitive-behavioral techniques with mindfulness and acceptance strategies, tailored for veterans' experiences. This approach aims to improve emotional regulation and interpersonal effectiveness, which are crucial for veterans reintegrating into society. The supportive group psychotherapy arm offers a comparative approach, fostering peer support and community, which can be vital for veterans feeling isolated. Together, these treatments offer a promising avenue for enhancing psychosocial functioning in this specific population.

What evidence suggests that this trial's treatments could be effective for improving psychosocial functioning in veterans?

Research shows that Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J), one of the treatments in this trial, may assist veterans with legal issues. Studies found that veterans participating in DBT-J improved in key treatment areas. Specifically, they were less likely to engage in future criminal behavior. These positive changes persisted a month after therapy concluded. Both veterans and their caregivers generally reported a good experience with the therapy. Overall, early evidence suggests DBT-J could enhance the social and emotional well-being of veterans involved in the justice system. ^{1 2 3 6 7}

Who Is on the Research Team?

Emily R Edwards, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

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

Able to provide consent

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

Exclusion Criteria

Limited English proficiency

Enrollment in a concurrent clinical trial

Prior participation in a DBT-J program

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 (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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10481711/

Dialectical Behavior Therapy for Justice-Involved Veterans ... Results suggested that DBT-J was also a generally acceptable intervention to veterans receiving the treatment, DBT-J providers, and adjunctive care providers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570393/

Dialectical Behavior Therapy for Justice-Involved Veterans Results of a small-scale, pre-post clinical trial suggested veterans participating in DBT-J experienced notable improvements across treatment targets during the ...

3. research.va.gov research.va.gov/about/funded_research/proj-details-FY2025.cfm?pid=776458

Dialectical Behavior Therapy for Justice-Involved Veterans Title: Dialectical Behavior Therapy for Justice-Involved Veterans: A Randomized Clinical Trial ; Principal Investigator: Emily R Edwards ; Location: Bronx, NY.

4. ctv.veeva.com ctv.veeva.com/study/dialectical-behavior-therapy-for-justice-involved-veterans

Dialectical Behavior Therapy for Justice-Involved Veterans Although preliminary, data also suggest participation in DBT-J may yield meaningful reductions in risk for future criminal behavior and ...

5. researchgate.net researchgate.net/publication/370002505_Dialectical_behavior_therapy_for_justice-involved_veterans_Changes_in_treatment_targets_in_a_small_pre-post_design_clinical_trial

Dialectical Behavior Therapy for Justice-Involved Veterans Results reflected notable improvements across treatment targets from pre- to posttreatment; these gains were largely maintained at 1-month ...

6. researchgate.net researchgate.net/publication/362417795_Dialectical_behavior_therapy_for_justice-involved_veterans_DBT-J_Feasibility_and_acceptability

Dialectical Behavior Therapy for Justice-Involved Veterans ... Results broadly suggested DBT-J to be characterized by high ease of implementation, successful recruitment efforts, strong participant ...

7. psycnet.apa.org psycnet.apa.org/doiLanding?doi=10.1037%2Fser0000691

Dialectical behavior therapy for justice-involved veterans (DBT ... Impact Statement. Justice-involved veterans are a high-risk, high-need subgroup serviced by behavioral health services within the Veterans Health Administration ...