PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05674617
- Status
- Recruiting
Conditions
- Stress Disorders, Post-Traumatic; Mental Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Written Exposure Therapy — BEHAVIORALWET will be conducted in accordance with the Written Exposure Therapy for PTSD: A Brief Treatment Approach for Mental Health Professionals Manual and the VA evidence-based practice (EBP) rollout training.
- PTSD Education — BEHAVIORALThe 5-session PTSD psychoeducation and skills protocol we will be utilizing for our PTSD education control condition was developed by PTSD clinical team (PCT) clinicians at the Washington DC VA Medical Center as a group protocol for Veterans admitted to the PCT and who were on the waitlist for individual therapy with an EBP for PTSD. The "PTSD 101" protocol consists of psychoeducation on topics related to PTSD symptoms and an introduction to PTSD-related coping skills. Its duration and structure will be similar to WET (5 weekly individual 50-minute sessions). To parallel the time an attention given in individual WET sessions more closely, participants will quietly review any written materials or videos that are a part of the manualized curriculum for 30 minutes of the session, bookended by a 10-minute check-in with their provider on symptoms and introduction to new materials at the start of session and another 10-minute debrief of reviewed materials at the end of session.
Study Details
PTSD is common among Veterans with serious mental illness (SMI). Co-occurring PTSD and SMI lead to poorer mental health and physical functioning than either diagnosis alone. Despite known high prevalence rates of PTSD in SMI populations as well as disparities in prevalence and treatment use for Black, Indigenous, and other people of color (BIPOC), little research has been done to: a) evaluate leading treatments for PTSD in individuals with SMI, and b) develop culturally responsive methods to integrate with PTSD treatments for SMI Veterans. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Written Exposure Therapy (WET), a VA evidence-based psychotherapy for PTSD in Veterans with SMI, and b) incorporating culturally responsive assessment methods. Results from this study will inform whether WET and culturally responsive assessment are feasible to implement, acceptable to Veterans with SMI, and worth examining in standard or optimized form in a larger clinical trial.
Key Dates
- Start date
- Dec 1, 2023
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Written Exposure Therapy (WET)5 individual therapy sessions of WET via video telehealth
- Active Comparator: PTSD Education Control5 individual sessions of PTSD psychoeducation via video telehealth
Primary Outcome Measure
Number of participants eligible divided by Individuals approached for recruitment [ Time Frame: Through study completion, an average of 1 year ]
Central Contacts
- Mary K Howell, PhD(410) 605-7000
- Amy L Drapalski, PhD(410) 637-1855
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | Mary K Howell, PhD (PRINCIPAL_INVESTIGATOR) |