What side effects are associated with this type of intervention?

Common treatments for PTSD, such as Dialectical Behavior Therapy (DBT) combined with Prolonged Exposure (PE) therapy, can have side effects including emotional distress, increased anxiety, and discomfort as patients confront and relive traumatic memories. These therapies are generally well-tolerated but can be emotionally taxing and require a high level of commitment, which may lead to dropout in some cases.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help alleviate PTSD symptoms by regulating serotonin levels in the brain. While Dialectical Behavior Therapy (DBT) and DBT Prolonged Exposure (DBT PE) are not FDA-approved treatments, they are evidence-based psychotherapeutic approaches that focus on emotional regulation, distress tolerance, and trauma-related symptom management. These therapies are often used in conjunction with pharmacological treatments to provide comprehensive care for individuals with PTSD.

What other types of research exist?

Promising novel alternatives to DBT + DBT PE for PTSD treatment include: 1) Web-Prolonged Exposure Therapy (Web-PE), which has shown efficacy in both controlled and open trials for military personnel and veterans, offering a convenient and accessible option. 2) MDMA-assisted therapy, which has demonstrated significant symptom reduction in severe PTSD cases in randomized, double-blind, placebo-controlled studies. 3) Stellate Ganglion Block (SGB), which has been effective in reducing PTSD symptoms in clinical trials. These alternatives provide diverse mechanisms and delivery methods, potentially enhancing treatment accessibility and effectiveness.

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Behavioral Intervention

Combined Therapies for PTSD

N/A

Recruiting

Led By Melanie S Harned, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (4 months in pe + srm, 12 months in dbt + dbt pe)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, therapies like DBT and PE may cause temporary increases in distress due to confronting traumatic memories or emotions during treatment sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (4 months in pe + srm, 12 months in dbt + dbt pe)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (4 months in pe + srm, 12 months in dbt + dbt pe)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (4 months in pe + srm, 12 months in dbt + dbt pe) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)

Secondary study objectives

Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales

Difficulties in Emotion Regulation Scale-16 (DERS-16)

+3 more

Other study objectives

Borderline Symptom List - Behavioral Supplement (BSL-BS)

Client Satisfaction Questionnaire (CSQ)

Credibility Expectancy Questionnaire (CEQ)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialectical Behavior Therapy

2016

Completed Phase 4

~960

Dialectical Behavior Therapy Prolonged Exposure protocol

2016

Completed Phase 3

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dialectical Behavior Therapy (DBT) focuses on emotional regulation, distress tolerance, and interpersonal effectiveness, helping PTSD patients manage intense emotions and improve relationships. DBT Prolonged Exposure (DBT PE) targets trauma-related symptoms by encouraging patients to confront and process traumatic memories in a safe environment. This combination aims to reduce the emotional impact of trauma and improve overall functioning, providing PTSD patients with tools to regain control over their symptoms and enhance their quality of life.

Theoretical and empirical issues in the treatment of post-traumatic stress disorder in Vietnam veterans.