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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~at study completion, approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Client Satisfaction Questionnaire (CSQ-8)
Mean number of sessions attended
Number of participants eligible divided by Individuals approached for recruitment
+2 more
Secondary study objectives
Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

Side effects data

From 2023 Phase 2 trial • 16 Patients • NCT04889664
85%
Fatigue
69%
Other
38%
Dizziness
38%
Headache
23%
Blurred Vision
15%
Difficulty Sleeping
15%
Frequent Urination
15%
Menstrual Irregularity
15%
Nausea/vomiting
8%
Increased Perspiration
8%
Decreased energy
8%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and Written Exposure Therapy

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: 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
1,663 Previous Clinical Trials
3,427,240 Total Patients Enrolled
Mary K Howell, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Media Library

Written Exposure Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05674617 — N/A
PTSD Research Study Groups: Written Exposure Therapy (WET), PTSD Education Control
PTSD Clinical Trial 2023: Written Exposure Therapy Highlights & Side Effects. Trial Name: NCT05674617 — N/A
Written Exposure Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674617 — N/A
~32 spots leftby Mar 2027
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