PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Written Exposure Therapy
BehavioralWET 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
BehavioralThe 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Written Exposure Therapy (WET)Experimental treatment 1 intervention
Group B: PTSD Education ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Post-treatment (~7 weeks)3
Retention and adherence rates
As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.
Time frame
at study completion, approximately 4 years4
Mean number of sessions attended
A measure of feasibility via adherence.
Time frame
at study completion, approximately 4 yearsSecondary outcomes
1
Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
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.
Time frame
Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)2
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
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.
Time frame
Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)Sponsors and contacts
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Source ClinicalTrials.gov