PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
- Conditions
- Stress Disorders, Post-Traumatic; Mental Disorders
- Interventions
- Behavioral: PTSD EducationBehavioral: Written Exposure Therapy
- Registration Number
- NCT05674617
- Lead Sponsor
- VA Office of Research and Development
- 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.
- Detailed Description
Project Background: PTSD is prevalent among Veterans and others with serious mental illness (SMI), contributing to substantial mental and physical health impairments. Written Exposure Therapy (WET) is a new evidence-based practice for PTSD that may have special clinical utility for Veterans with SMI and PTSD. However, such Veterans have been largely excluded from PTSD clinical trials, and no WET trials to date have focused on an SMI population. Further, there are significant race and ethnicity disparities in PTSD and SMI prevalence and treatment, even in Veterans Health Administration. For instance, persistence and chronicity of SMI and PTSD are higher for Black, Indigenous, and other people of color (BIPOC) underlining the need for PTSD EBPs to be delivered in culturally responsive ways.
Project Objectives: The proposed CDA-2 research will address research and clinical gaps by integrating culturally responsive assessment methods and testing the feasibility and acceptability of WET among Veterans with SMI and PTSD. The first step of this research will focus on administering culturally responsive assessments and WET to Veterans with PTSD and SMI in a training trial (n = 10), including qualitative interviews exploring participants' experiences with and views of these instruments and WET. The second step will involve completing a small randomized controlled trial of WET to examine feasibility, acceptability, and fidelity of WET, and to preliminarily explore changes to clinical outcomes and functioning among 48 Veterans randomized to WET (n = 32) vs. a PTSD psychoeducation control intervention (n = 16). We will assess rates of recruitment, initial intervention engagement, and session attendance (feasibility); Veteran satisfaction with WET (acceptability); and preliminarily explore response to WET. The final step of this research will involve conducting a process evaluation to consider ways to optimize WET for future clinical trials to improve functional recovery for Veterans with SMI. This evaluation will synthesize information from: 1) WET interventionist notes and 2) qualitative interviews with a subset of Veterans in the WET condition (n = 15).
Project Methods: This project will include: 1) delivering WET with the CFI during a training trial followed by qualitative interviews with Veterans with PTSD and SMI; 2) completing a randomized control trial (RCT) with 48 Veteran participants, monitoring fidelity, feasibility, and acceptability; and 3) studying Veterans' experiences of WET and culturally responsive assessment methods through qualitative interviews. The investigators will measure functional outcomes during the RCT at baseline, post-treatment and 3-month follow-up using clinician-rated and self-report questionnaires for preliminary exploratory analysis, preparatory to a future full RCT if WET proves promising.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTSD Education Control PTSD Education 5 individual sessions of PTSD psychoeducation via video telehealth Written Exposure Therapy (WET) Written Exposure Therapy 5 individual therapy sessions of WET via video telehealth
- Primary Outcome Measures
Name Time Method Retention and adherence rates at study completion, approximately 4 years As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.
Number of participants eligible divided by Individuals approached for recruitment Through study completion, an average of 1 year 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.
Client Satisfaction Questionnaire (CSQ-8) Post-treatment (~7 weeks) 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.
Mean number of sessions attended at study completion, approximately 4 years A measure of feasibility via adherence.
Treatment dropout percentage at study completion, approximately 4 years 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.
- Secondary Outcome Measures
Name Time Method World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks) Health-related functioning Full measure title: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Minimum score: 0 Maximum score: 100 Score interpretation: Greater scores indicate greater disability and/or functional impairments.
Citation: Ustun, T., Chatterji, S., Kostanjsek, N., et al. (2010). Developing the World Health Organization Disability Assessment Schedule 2.0. Bulletin of the World Health Organization, 88(11), 815-823.Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks) PTSD symptom improvement Full measure title: Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version Minimum score: 0 Maximum score: 80 Score interpretation: Greater scores indicate greater severity of PTSD symptoms.
Citation: Weathers, F. W., Blake, D. D., Schnurr, P. P., et al. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Available online from the National Center for PTSD.
Trial Locations
- Locations (1)
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
🇺🇸Baltimore, Maryland, United States