PTSD Treatment for Veterans with Mental Illness

Overseen By Amy L Drapalski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Trauma-focused EBP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

48 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Written Exposure Therapy (WET) for PTSD?

Research shows that Written Exposure Therapy (WET) is effective for treating PTSD, including among veterans. It is a brief treatment that leads to significant symptom improvement and is comparable to other longer therapies. ^{1 2 3 4 5}

Is Written Exposure Therapy (WET) safe for veterans with PTSD?

Written Exposure Therapy (WET) has been shown to be well tolerated by veterans with PTSD, with high satisfaction ratings and no reported adverse events during treatment. ^{1 3 4 6 7}

How is Written Exposure Therapy (WET) different from other PTSD treatments?

Written Exposure Therapy (WET) is unique because it is a brief treatment requiring only five sessions, with no homework between sessions, making it more efficient and easier to complete compared to other PTSD treatments that typically require 8 to 15 sessions. ^{1 2 3 4 5}

Research Team

Mary K Howell, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Eligibility Criteria

This trial is for Veterans with serious mental illness (SMI) such as psychotic spectrum or bipolar disorders, who are also diagnosed with PTSD. They must be enrolled in outpatient mental health services and have regular phone access. Those already in trauma-focused therapy or with moderate-to-severe substance use issues cannot participate.

Inclusion Criteria

I have been diagnosed with PTSD by a professional using the CAPS-5 assessment.

Regular telephone access

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))

Exclusion Criteria

Engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care

I am currently in or recently completed a PTSD therapy program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training Trial

Administer culturally responsive assessments and Written Exposure Therapy (WET) to Veterans with PTSD and SMI, followed by qualitative interviews

5 weeks

5 visits (virtual)

Randomized Controlled Trial

Conduct a small RCT to examine feasibility, acceptability, and fidelity of WET, and explore changes to clinical outcomes and functioning

7 weeks

5 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (virtual)

Treatment Details

Interventions

• PTSD Education
• Written Exposure Therapy

Trial Overview The study tests the feasibility of Written Exposure Therapy (WET), a treatment for PTSD, in Veterans with SMI. It also evaluates culturally responsive assessment methods to see if they're suitable and acceptable for this group before considering a larger trial.

Participant Groups

Group I: Written Exposure Therapy (WET) Experimental Treatment 1 Intervention

5 individual therapy sessions of WET via video telehealth

Group II: PTSD Education Control Active Control 1 Intervention

5 individual sessions of PTSD psychoeducation via video telehealth

Written Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Written Exposure Therapy for:

• Post-Traumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Written exposure therapy (WET) significantly reduced PTSD symptoms in Korean patients, with 60.9% of participants no longer meeting PTSD criteria at 6 weeks, increasing to 77.8% at 24 weeks, demonstrating its efficacy.

The therapy also improved depressive symptoms and global functioning, with a low dropout rate of 8%, indicating that WET is a feasible and effective treatment option for PTSD in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. Park, JE., Choi, KS., Han, YR., et al.[2021]

Written exposure therapy, a brief 5-session intervention, was found to be noninferior to the more intensive cognitive processing therapy in treating PTSD among military service members, indicating it can be an effective alternative.

The study involved 169 active-duty military participants, with a high completion rate of 76.5% for written exposure therapy, suggesting it may be a more efficient treatment option with lower dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. Sloan, DM., Marx, BP., Resick, PA., et al.[2022]

Written Exposure Therapy (WET) is an effective 5-session treatment for PTSD that shows significant symptom improvement and requires less time from both patients and therapists compared to traditional therapies.

WET has similar efficacy to Cognitive Processing Therapy (CPT) but with a much lower dropout rate (6% for WET vs. 39% for CPT), making it a promising option for diverse populations, including veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief novel therapies for PTSD: Written Exposure Therapy. Thompson-Hollands, J., Marx, BP., Sloan, DM.[2022]

Written Exposure Therapy (WET) is as effective as Cognitive Processing Therapy (CPT) for treating PTSD, maintaining similar outcomes even 60 weeks after treatment, with large effects on PTSD symptoms for both therapies.

Both WET and CPT significantly reduced depressive symptoms over the study period, although CPT showed a quicker reduction; however, the overall difference in effectiveness for depression was small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment gains of a brief exposure-based treatment for PTSD. Thompson-Hollands, J., Marx, BP., Lee, DJ., et al.[2022]

Written exposure therapy (WET) was found to be noninferior to prolonged exposure therapy (PE) in reducing PTSD symptoms among 178 veterans, demonstrating similar effectiveness with fewer sessions required.

Participants in the WET group had significantly lower dropout rates (12.5%) compared to those in the PE group (35.6%), suggesting that WET may be a more accessible treatment option for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. Sloan, DM., Marx, BP., Acierno, R., et al.[2023]

Written exposure therapy was found to be well tolerated and received by a small group of 7 male veterans with PTSD, with only 1 dropout and no adverse events reported during treatment.

Significant improvements in PTSD symptoms were observed, with 5 out of 7 veterans no longer meeting the diagnostic criteria for PTSD three months after treatment, indicating potential effectiveness for this brief intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written exposure therapy for veterans diagnosed with PTSD: a pilot study. Sloan, DM., Lee, DJ., Litwack, SD., et al.[2022]

Written Exposure Therapy (WET) is being tested as a more efficient treatment for PTSD in veterans, potentially offering a less time-intensive alternative to traditional therapies like Prolonged Exposure (PE).

The ongoing randomized controlled trial will involve 150 veterans and aims to determine if WET is as effective as PE in reducing PTSD symptoms, which could significantly improve access to care for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing written exposure therapy to Prolonged Exposure for the treatment of PTSD in a veteran sample: A non-inferiority randomized design. Sloan, DM., Marx, BP., Acierno, R., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Brief novel therapies for PTSD: Written Exposure Therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Written exposure therapy for veterans diagnosed with PTSD: a pilot study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing written exposure therapy to Prolonged Exposure for the treatment of PTSD in a veteran sample: A non-inferiority randomized design. [2022]