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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 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

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,448 Total Patients Enrolled
Melanie S Harned, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
1 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Dialectical Behavior Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05974631 — N/A
PTSD Research Study Groups: DBT + DBT PE, PE + SRM
PTSD Clinical Trial 2023: Dialectical Behavior Therapy Highlights & Side Effects. Trial Name: NCT05974631 — N/A
Dialectical Behavior Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05974631 — N/A
~133 spots leftby Apr 2027