Clinical trial NCT05674617: PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Official title: PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic; Mental Disorders
Keywords: Stress Disorders, Post-Traumatic
Mental Disorders
Culturally responsive assessment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (RCT)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants eligible divided by Individuals approached for recruitment
timeFrame: Through study completion, an average of 1 year
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (~7 weeks)
measure: Retention and adherence rates
timeFrame: at study completion, approximately 4 years
measure: Mean number of sessions attended
timeFrame: at study completion, approximately 4 years
measure: Treatment dropout percentage
timeFrame: at study completion, approximately 4 years
Secondary outcomes:
measure: Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
timeFrame: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Mary K Howell, PhD
role: PRINCIPAL_INVESTIGATOR
References: