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

NCT05674617 | Recruiting DMC

• 2 other identifiers: D4272-W1IK2RX004272-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Number of participants eligible divided by Individuals approached for recruitment

  As a measure of feasibility, the investigators will evaluate recruitment and suitability of eligibility criteria by calculating number eligible participants (e.g., those that passed screening) divided by number potential participants that were approached for recruitment.

  Through study completion, an average of 1 year

• Client Satisfaction Questionnaire (CSQ-8)

  Acceptability Full measure title: Client Satisfaction Questionnaire (CSQ-8) Minimum score: 8 Maximum score: 32 Score interpretation: Greater scores indicate greater client satisfaction. Citation: Attkisson, C. C., \& Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcome assessment (p. 402-420). Hillsdale, NJ, US: Lawrence Erlbaum Associates, Inc.

  Post-treatment (~7 weeks)

• Retention and adherence rates

  As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.

  at study completion, approximately 4 years

• Mean number of sessions attended

  A measure of feasibility via adherence.

  at study completion, approximately 4 years

• Treatment dropout percentage

  As a measure of feasibility, the investigators will calculate treatment dropout percentage based on the number who dropped out prior to completing treatment divided by the number who engaged.

  at study completion, approximately 4 years

Secondary Outcomes (2)

• Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version

  Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)

Study Arms (2)

Written Exposure Therapy (WET)

EXPERIMENTAL

5 individual therapy sessions of WET via video telehealth

Behavioral: Written Exposure Therapy

PTSD Education Control

ACTIVE COMPARATOR

5 individual sessions of PTSD psychoeducation via video telehealth

Behavioral: PTSD Education

Interventions

PTSD Education BEHAVIORAL

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.

PTSD Education Control

Written Exposure Therapy BEHAVIORAL

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.

Also known as: WET

Written Exposure Therapy (WET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Traumatic; Mental Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Study Officials

• Mary K Howell, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary K Howell, PhD

CONTACT

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

Amy L Drapalski, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: randomized controlled trial (RCT)

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 6, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)