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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
Project Background: PTSD is prevalent among Veterans and others with serious mentalillness (SMI), contributing to substantial mental and physical health impairments.Written Exposure Therapy (WET) is a new evidence‐based practice for PTSD that may havespecial clinical utility for Veterans with SMI and PTSD. However, such Veterans have beenlargely excluded from PTSD clinical trials, and no WET trials to date have focused on anSMI population. Further, there are significant race and ethnicity disparities in PTSD andSMI prevalence and treatment, even in Veterans Health Administration. For instance,persistence and chronicity of SMI and PTSD are higher for Black, Indigenous, and otherpeople of color (BIPOC) underlining the need for PTSD EBPs to be delivered in culturallyresponsive ways.Project Objectives: The proposed CDA‐2 research will address research and clinical gapsby integrating culturally responsive assessment methods and testing the feasibility andacceptability of WET among Veterans with SMI and PTSD. The first step of this researchwill focus on administering culturally responsive assessments and WET to Veterans withPTSD and SMI in a training trial (n = 10), including qualitative interviews exploringparticipants' experiences with and views of these instruments and WET. The second stepwill involve completing a small randomized controlled trial of WET to examinefeasibility, acceptability, and fidelity of WET, and to preliminarily explore changes toclinical outcomes and functioning among 48 Veterans randomized to WET (n = 32) vs. a PTSDpsychoeducation control intervention (n = 16). We will assess rates of recruitment,initial intervention engagement, and session attendance (feasibility); Veteransatisfaction with WET (acceptability); and preliminarily explore response to WET. Thefinal step of this research will involve conducting a process evaluation to consider waysto optimize WET for future clinical trials to improve functional recovery for Veteranswith SMI. This evaluation will synthesize information from: 1) WET interventionist notesand 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 atraining trial followed by qualitative interviews with Veterans with PTSD and SMI; 2)completing a randomized control trial (RCT) with 48 Veteran participants, monitoringfidelity, feasibility, and acceptability; and 3) studying Veterans' experiences of WETand culturally responsive assessment methods through qualitative interviews. Theinvestigators will measure functional outcomes during the RCT at baseline, post‐treatmentand 3‐month follow‐up using clinician‐rated and self‐report questionnaires forpreliminary exploratory analysis, preparatory to a future full RCT if WET provespromising.
Epistemonikos ID: aa9576b47773c8502643deab631d5108bc642dd6
First added on: Feb 19, 2024