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Behavioral Intervention
PTSD Treatment for Veterans with Mental Illness
N/A
Recruiting
Led By Mary K Howell, 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 at study completion, approximately 4 years
Awards & highlights
Study Summary
This trial aims to develop and test treatments for PTSD in Veterans with serious mental illness (SMI) to improve their mental health. BIPOC disparities in prevalence and treatment use will be addressed.
Who is the study for?
This trial is for Veterans with serious mental illness (SMI) such as psychotic spectrum or bipolar disorders, who are also diagnosed with PTSD. They must be enrolled in outpatient mental health services and have regular phone access. Those already in trauma-focused therapy or with moderate-to-severe substance use issues cannot participate.Check my eligibility
What is being tested?
The study tests the feasibility of Written Exposure Therapy (WET), a treatment for PTSD, in Veterans with SMI. It also evaluates culturally responsive assessment methods to see if they're suitable and acceptable for this group before considering a larger trial.See study design
What are the potential side effects?
While specific side effects are not listed, psychological therapies like WET may sometimes cause temporary increases in distress due to recalling traumatic events during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Client Satisfaction Questionnaire (CSQ-8)
Mean number of sessions attended
Number of participants eligible divided by Individuals approached for recruitment
+2 moreSecondary outcome measures
Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Written Exposure Therapy (WET)Experimental Treatment1 Intervention
5 individual therapy sessions of WET via video telehealth
Group II: PTSD Education ControlActive Control1 Intervention
5 individual sessions of PTSD psychoeducation via video telehealth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,236 Total Patients Enrolled
Mary K Howell, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PTSD by a professional using the CAPS-5 assessment.I am currently in or recently completed a PTSD therapy program.My condition is diagnosed as a severe mental illness, such as psychosis or bipolar disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Written Exposure Therapy (WET)
- Group 2: PTSD Education Control
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.
Are there any vacancies available for participants in this trial?
"According to data hosted on clinicaltrials.gov, this experiment has ceased its recruitment process as of the most recent update on May 1st 2023. Nevertheless, there are over seven hundred other trials that still require patients at present time."
Answered by AI
Who else is applying?
What site did they apply to?
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
What portion of applicants met pre-screening criteria?
Met criteria
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