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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Written Exposure Therapy (WET) to assist Veterans with PTSD and serious mental illness (SMI), such as bipolar disorder or schizophrenia. The goal is to determine if WET can be effectively adapted for this group, with a focus on Black, Indigenous, and other people of color. Participants will attend five individual therapy sessions via video. Veterans with regular phone access who are already receiving outpatient mental health services are well-suited for this trial. As an unphased trial, this study allows Veterans to contribute to innovative research that could lead to more effective treatments for PTSD and SMI.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Written Exposure Therapy (WET) is safe and effective for treating PTSD. Patients with both PTSD and other mood disorders have tolerated WET well in studies. Most patients experienced a reduction in PTSD symptoms after treatment, suggesting that the therapy might be safe for people with PTSD and other serious mental health issues.

Some participants might feel mild emotional discomfort during therapy sessions, but these feelings are usually manageable. Overall, WET has shown promising results, making it a potential option for those dealing with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy (WET) for PTSD because it offers a simple yet effective approach that can be delivered via video telehealth, making it accessible for veterans who might have difficulty attending in-person sessions. Unlike traditional therapies like Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE), which can be lengthy and complex, WET involves just five sessions focused on writing about traumatic experiences, which can be less intimidating and time-consuming. This method could potentially lead to quicker relief of PTSD symptoms, providing a valuable alternative for those seeking efficient and accessible treatment options.

What evidence suggests that this trial's treatments could be effective for PTSD in Veterans with SMI?

Research has shown that Written Exposure Therapy (WET), one of the treatments studied in this trial, effectively treats PTSD. Studies have found that WET significantly reduces PTSD symptoms, leading to strong improvement. It also helps with depression symptoms, showing moderate improvement. WET is considered as effective as other PTSD treatments that take more time, making it a promising option for people who need treatment but might not have much time. Overall, WET is safe and effective for people with PTSD, even those with other mood disorders or substance use issues. Participants in this trial may receive WET or join the PTSD Education Control group, which involves PTSD psychoeducation sessions. ^{1 2 6 7 8}

Who Is on the Research Team?

Mary K Howell, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 (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) 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) 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789424000297

State of the Science: Written Exposure Therapy for ... The evidence indicates that WET is an efficacious and effective treatment approach for PTSD and is noninferior to more time-intensive evidence-based treatments ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... These findings suggest that WET is a viable option for PTSD treatment and has the potential to reach a greater number of individuals who are in need of PTSD ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01800773

Written Exposure Therapy for Posttraumatic Stress Disorder Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/written_exposure_therapy.asp

Written Exposure Therapy for PTSD - PTSD: National ... Findings to date indicate WET is safe and effective for PTSD patients with comorbid mood disorder symptoms, (4,6, 24-27) substance use disorders, (28,29), ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34726451/

Effectiveness of written exposure therapy for posttraumatic ... Results: Intent-to-treat analyses indicated that WET was effective in reducing PTSD symptoms (d = .84), depression symptoms (d = .47), and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8079278/

Comparing written exposure therapy to ... - PubMed Central In an ongoing randomized controlled trial (RCT) we are investigating whether WET is non-inferior in treating PTSD compared with the more time intensive PE.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666560323000713

Supporting the implementation of written exposure therapy ... This paper presents implementation process outcomes of Written Exposure Therapy (WET), a brief, scalable, and sustainable evidence-based PTSD treatment ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8390941/

An Open Pilot Trial of Written Exposure Therapy ... In total, 25 patients started WET. Findings showed a significant reduction in the rate of PTSD diagnosis and symptom severity scores. Fourteen of 23 (60.9%) ...