RecruitingNot ApplicableNCT05674617

PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes


Sponsor

VA Office of Research and Development

Enrollment

48 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized PTSD treatment for veterans who also have serious mental illnesses like schizophrenia or bipolar disorder. Researchers want to see if this therapy can help improve daily functioning and quality of life for veterans managing both conditions at once. **You may be eligible if...** - You are a veteran receiving outpatient mental health care at a VA facility - You have been diagnosed with PTSD (confirmed by clinical assessment) - You also have a serious mental illness such as a psychotic or bipolar disorder - You have regular access to a phone **You may NOT be eligible if...** - You are currently struggling with moderate to severe substance use that would need a higher level of care - You are already doing (or recently completed) a trauma-focused therapy like CPT, Prolonged Exposure, EMDR, or Written Exposure Therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALWritten Exposure Therapy

WET 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.

BEHAVIORALPTSD Education

The 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.


Locations(1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

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NCT05674617