Written Exposure Therapy for PTSD in Veterans with Substance Use Disorders

(WET Trial)

Overseen By Michael Merritt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Schizophrenia, Bipolar, Suicidal, 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: 8

Duration: 5 weeks

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of written exposure therapy for Veterans with both PTSD and substance use disorders. It focuses on whether writing about traumatic events can reduce PTSD symptoms when combined with regular treatment, compared to writing about neutral topics. Veterans receiving treatment for substance use at the VA who also have PTSD and a substance use disorder may be suitable candidates. The trial aims to discover better methods to help Veterans improve their mental health while managing substance use issues. As an unphased trial, it offers Veterans a unique opportunity to contribute to innovative research that could enhance mental health treatments.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Written Exposure Therapy is safe for Veterans with PTSD and Substance Use Disorders?

Research has shown that Written Exposure Therapy (WET) is safe and well-tolerated for people with PTSD, even for those with additional mental health issues like mood disorders and substance use disorders. In previous studies, participants reported high satisfaction with WET, and fewer people dropped out compared to other treatments. This suggests that most people manage the therapy well without serious problems. For those considering joining a trial using WET, these findings might help ease concerns about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard PTSD treatments, which often involve medication or verbal therapy, Written Exposure Therapy (WET) focuses on the power of writing. WET is unique because it requires patients to write about their traumatic experiences in detail over five sessions, helping them process deep emotions. This approach is less about conversation and more about personal reflection through writing, allowing for an introspective and potentially transformative experience. Researchers are excited about WET because it offers a structured yet personal way to address trauma, potentially making it more accessible and less intimidating than traditional therapies.

What evidence suggests that Written Exposure Therapy is effective for PTSD in Veterans with Substance Use Disorders?

Research has shown that Written Exposure Therapy (WET), one of the treatments in this trial, effectively treats PTSD. Studies have found that WET significantly reduces PTSD symptoms and also alleviates depression. Veterans with PTSD and substance use issues have reported high satisfaction with this therapy and often continue with it. Specifically, early results from a small study with Veterans showed a reduction in PTSD symptoms when using WET. This suggests WET could be a promising option for those facing both PTSD and substance use challenges. Another treatment arm in this trial involves Neutral Topic Writing, which serves as an active comparator. ^{1 2 3 6 7}

Who Is on the Research Team?

Sarah Meshberg-Cohen, PhD MS BS

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veterans approved for substance use disorder (SUD) treatment at VA Connecticut Healthcare System, aged 18 or older, who have both SUD and PTSD. It's not open to those with schizophrenia-type disorders, current severe suicidal or homicidal risks, recent PTSD psychotherapy within the past 6 months, or literacy issues.

Inclusion Criteria

I am a veteran and 18 years old or older.

I have been diagnosed with PTSD.

You have been diagnosed with a substance use disorder (SUD) according to the DSM-5.

Exclusion Criteria

current suicidal or homicidal risks necessitating a higher level of care;

I am a veteran who has undergone PTSD therapy in the last 6 months.

Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Written Exposure Therapy (WET) or a neutral topic writing condition over 5 sessions

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for PTSD and substance use outcomes post-treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Neutral Topic Writing
• Written Exposure Therapy

Trial Overview

The study tests Written Exposure Therapy (WET), a brief trauma-focused intervention aimed at treating PTSD in Veterans with co-occurring SUD. Participants will be compared to those writing on neutral topics to see if WET leads to better outcomes.

How Is the Trial Designed?

Group I: Written Exposure Therapy Experimental Treatment 1 Intervention

Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Group II: Neutral Topic Writing Active Control 1 Intervention

Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

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 (WET) significantly reduced PTSD symptoms in pregnant women, with improvements lasting up to 6 months postpartum, indicating its potential effectiveness for this population.

The intervention was found to be feasible and acceptable, with high participant satisfaction and strong therapist adherence to the treatment protocol, suggesting it could be a viable option for managing PTSD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Nillni, YI., Baul, TD., Paul, E., et al.[2023]

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, 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) 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) 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 (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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38365173/

Written exposure therapy for veterans with co-occurring ...

Written exposure therapy (WET), a five-session evidence-based psychotherapy (EBP) for PTSD, has high patient satisfaction, and lower dropout ...

2.

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), ...

3.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ...

This randomized clinical trial compares treatment outcomes for written exposure therapy and prolonged exposure therapy among veterans ...

4.

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05327504

Written Exposure Therapy for Veterans With SUD and PTSD

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11275991/

Effects on PTSD and Depressive Symptoms

Findings demonstrate that brief, group-delivered WET shows promise for addressing PTSD and depressive symptoms in residential SUD treatment.

7.

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 ...