Recruiting

PTSD Treatment

Sponsor:

VA Office of Research and Development

Code:

NCT05674617

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Written Exposure Therapy

PTSD Education

Study Details

Brief 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.

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders

Study ID

NCT05674617

Start date

Dec 1, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • enrolled in outpatient mental health services within the VAMHCS (including general outpatient Mental Health Clinic (MHC), Psychosocial Rehabilitation and Recovery Centers (PRRCs), Mental Health Intensive Case Management (MHICM), and PTSD Clinical Teams (PCTs))
  • diagnosis of PTSD as confirmed by assessment with the Clinician-administered PTSD Scale for DSM-5 (CAPS-5) past month version
  • SMI diagnosis as defined by VHA Directive 1160 (i.e., psychotic spectrum or bipolar disorders) as confirmed by the medical record
  • regular telephone access

Exclusion Criteria:

  • are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care
  • already engaged in trauma-focused EBP for PTSD (e.g., WET, CPT, PE, or EMDR) or completed an EBP for PTSD within the past 6 months

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Written Exposure Therapy (WET)

5 individual therapy sessions of WET via video telehealth

active comparator: PTSD Education Control

5 individual sessions of PTSD psychoeducation via video telehealth

Interventions

Written 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.

PTSD 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.

Primary outcome measure

  • Number of participants eligible divided by Individuals approached for recruitment [ Time Frame: Through study completion, an average of 1 year ]
  • Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-treatment (~7 weeks) ]
  • Retention and adherence rates [ Time Frame: at study completion, approximately 4 years ]
  • Mean number of sessions attended [ Time Frame: at study completion, approximately 4 years ]
  • Treatment dropout percentage [ Time Frame: at study completion, approximately 4 years ]

Central Contacts and Locations

Central contacts

Mary K Howell, PhD

(410) 605-7000Mary.Howell@va.gov

Amy L Drapalski, PhD

(410) 637-1855amy.drapalski@va.gov

Locations

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Cynthia Y Giron-Hernandez

(805) 478-7948cynthia.giron-hernandez@va.gov

Alicia Lucksted, PhD

(410) 637-1858Alicia.Lucksted@va.gov

Principal Investigator:

Mary K Howell, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Stress Disorders, Post-Traumatic
  • Mental Disorders
  • Culturally responsive assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-06.