Stress Disorders, Post-Traumatic; Mental DisordersNCT05674617
PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
A study testing Written Exposure Therapy and PTSD Education in people with Stress Disorders, Post-Traumatic; Mental Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic; Mental Disorders
- What is being tested?
- Written Exposure Therapy and PTSD Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Cynthia Y Giron-Hernandez, (805) 478-7948, cynthia.giron-hernandez@va.gov
Alicia Lucksted, PhD, (410) 637-1858, Alicia.Lucksted@va.gov
About this study
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.
Read the 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.
- Being tested
- Written Exposure Therapy, PTSD Education
- Keywords
- Stress Disorders, Post-Traumatic, Mental Disorders, Culturally responsive assessment
- Medical subject headings
- Stress Disorders, Traumatic, Mental Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
Also called WET
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.
PTSD EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy (WET) | Experimental | 5 individual therapy sessions of WET via video telehealth Receives: Behavioral: Written Exposure Therapy |
| PTSD Education Control | Active comparator | 5 individual sessions of PTSD psychoeducation via video telehealth Receives: Behavioral: PTSD Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at study completion, approximately 4 years
Mean number of sessions attended
A measure of feasibility via adherence.
Measured: 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.
Measured: at study completion, approximately 4 years
Secondary outcomes (2)
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.
Measured: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
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.
Measured: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Dec 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-Traumatic; Mental DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary K Howell, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674617
- Sponsor's protocol ID
- D4272-W
- Other IDs
- 1IK2RX004272-01A1
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
- ClinicalTrials.gov ID
- NCT05674617
- Acronym / sponsor ID
- D4272-W
- Keywords
- Stress Disorders, Post-Traumatic, Mental Disorders, Culturally responsive assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy (WET) | Experimental | Behavioral: Written Exposure Therapy5 individual therapy sessions of WET via video telehealth |
| PTSD Education Control | Active comparator | Behavioral: PTSD Education5 individual sessions of PTSD psychoeducation via video telehealth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Exposure TherapyAlso: WETWET 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. | Behavioural | Written Exposure Therapy (WET) |
| PTSD EducationThe 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. | Behavioural | PTSD Education Control |
Primary outcome
Number of participants eligible divided by Individuals approached for recruitment
Time frame: 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)
Time frame: 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.
Retention and adherence rates
Time frame: at study completion, approximately 4 years
As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.
Mean number of sessions attended
Time frame: at study completion, approximately 4 years
A measure of feasibility via adherence.
Treatment dropout percentage
Time frame: 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.
2 secondary outcomes
Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
Time frame: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-Traumatic; Mental Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary K Howell, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and PTSD Education in people with Stress Disorders, Post-Traumatic; Mental Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary K Howell, PhD ((410) 605-7000, Mary.Howell@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants eligible divided by Individuals approached for recruitment (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.