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Behavioral Intervention
Combined Therapies for PTSD
N/A
Waitlist Available
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
Study Summary
This trial will measure if combining 2 therapies for PTSD reduces suicide risk in Veterans more effectively than the current standard of care. Results will help inform treatment guidelines for this high-risk population.
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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
Secondary outcome measures
Beck Scale for Suicide Ideation (BSSI)
Brief Symptom Inventory (BSI)
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
+3 moreOther outcome measures
Borderline Symptom List - Behavioral Supplement (BSL-BS)
Client Satisfaction Questionnaire (CSQ)
Credibility Expectancy Questionnaire (CEQ)
+7 moreTrial 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
~820
Dialectical Behavior Therapy Prolonged Exposure protocol
2016
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,403 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been receiving DBT or PE therapy in the past year.I am currently having thoughts about harming myself.I will be available and not planning to move for the next 18 months.I cannot ensure my own safety without help.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: DBT + DBT PE
- Group 2: PE + SRM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently available?
"Per the clinicaltrials.gov website, this medical study is no longer accepting applicants. It was initially posted on February 1st 2024 and its last edit occured on July 25th 2023. Nonetheless, there are 324 other trials actively seeking patients as of today."
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