Written Exposure Therapy for PTSD and Substance Use Disorders

Overseen By Dana Holohan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Current manic episode, suicidal intent, 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: 1

Duration: 4 weeks

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) for veterans with both PTSD and substance use disorder. The goal is to determine if WET can improve symptoms such as substance use, PTSD, depression, and overall quality of life when added to the usual treatment program. Participants will join a 28-day residential program and be divided into two groups: one receiving standard care and the other receiving additional WET sessions. Veterans with both PTSD and substance use issues who are part of this residential program are well-suited for the study. Feedback from participants and providers will help refine the treatment for future use. As an unphased trial, this study offers veterans the opportunity to contribute to innovative treatment approaches that could enhance their recovery journey.

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

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for more information.

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

Research has shown that Written Exposure Therapy (WET) is a safe treatment for people with PTSD and substance use disorders. Studies have found that WET helps reduce PTSD symptoms and is well-tolerated by patients, including those with mood disorders or substance use issues. This indicates that the treatment typically doesn't cause serious side effects or problems for participants. Evidence supports that WET can be a helpful and manageable option for individuals dealing with both PTSD and substance use concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy (WET) for PTSD and Substance Use Disorders because it offers a fresh approach to therapy. Unlike other treatments like Cognitive-Behavioral Therapy, which often require lengthy sessions and homework, WET is concise and structured, with each session lasting just 40-60 minutes. Patients engage in focused writing exercises, guided by trained therapists, allowing them to process trauma without the need for formal homework. This method is not only time-efficient but also accessible, as it can be delivered in a residential setting, potentially making therapy more manageable for those with substance use disorders.

What evidence suggests that this trial's treatments could be effective for PTSD and Substance Use Disorders?

Research has shown that Written Exposure Therapy (WET), which participants in this trial may receive as part of the resWET arm, effectively treats PTSD. Studies indicate that WET helps reduce PTSD and depression symptoms, even in individuals with substance use issues. WET is safe and can improve mental health in veterans with PTSD. In one study, veterans with PTSD showed significant symptom improvement with WET. This therapy is brief and can be easily offered in various settings, making it a practical choice. ^{1 2 3 4 6}

Who Is on the Research Team?

Dana Holohan

Principal Investigator

Salem VA Medical Center, Salem, VA

Are You a Good Fit for This Trial?

This trial is for veterans enrolled in a residential substance use disorder program at the Salem VAMC who have both PTSD and SUD. It's not open to those currently experiencing a manic episode, with current suicidal intent, previous Written Exposure treatment, or inability to write.

Inclusion Criteria

Enrolled in the residential substance use disorder treatment program (DOM SUD) at the Salem VAMC

I have been diagnosed with both a substance use disorder and PTSD.

Exclusion Criteria

Current Suicidal Intent

Previous Written Exposure treatment

I am currently experiencing a manic episode.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 28-day residential SUD program with or without Written Exposure Therapy (WET) sessions

4 weeks

Weekly in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month and 3 months

12 weeks

Assessments at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Residential Written Exposure Therapy
• Treatment as Usual

Trial Overview The study tests if adding Written Exposure Therapy (WET) to usual substance use disorder treatment helps veterans with PTSD and SUD. Participants are randomly assigned to receive either standard treatment or standard plus WET over five sessions.

How Is the Trial Designed?

Group I: resWET Experimental Treatment 1 Intervention

Residential Written Exposure Therapy (resWET): Treatment as Usual (TAU) plus 5-individual Written Exposure Therapy (WET) sessions (40-60 min each; Marx \& Sloan, 2019) twice a week for two weeks and once a week for the final session, administered by WET trained psychologists, social workers, or postdoctoral residents. Treatment instructions are read, patients write for 30 minutes, and the writing is briefly processed. No formal written homework is required.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Treatment as Usual (DOM SUD): The DOM SUD (TAU) is a 24-bed intensive substance use disorder (SUD) residential program with a typical 28-day length of stay. The program focuses on evidence-based treatments for SUD such as Cognitive-Behavioral Therapy, Motivational Enhancement Therapy, Medication Assisted Treatment, and Contingency Management therapy. Patients diagnosed with Post-traumatic Stress Disorder (PTSD) are typically referred to outpatient PTSD treatment following DOM SUD and often attend Seeking Safety during the program. Most of the programming is group-based though Veterans also have weekly individual case management appointments.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

Center for Biostatistics and Health Data Science

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study involving 353 women in substance abuse treatment, the integrated PTSD treatment (Seeking Safety) did not result in significantly more adverse events compared to a non-trauma-focused intervention (Women's Health Education), indicating that it is safe to implement PTSD treatment in these settings.

Both interventions had low rates of adverse events (9.6% for Seeking Safety and 7.2% for Women's Health Education), suggesting that addressing PTSD in substance abuse programs does not worsen psychiatric or substance use symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Killeen, T., Hien, D., Campbell, A., 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]

In a study involving 221 participants with PTSD and substance use disorders, integrated cognitive-behavioral therapy (ICBT) showed better outcomes in reducing drug use compared to individual addiction counseling (IAC) and standard care (SC), although PTSD symptoms improved similarly across all groups.

ICBT also resulted in higher therapy retention rates than IAC, indicating that patients were more likely to continue treatment, and there were no unexpected adverse events reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. McGovern, MP., Lambert-Harris, C., Xie, H., et al.[2022]

In a study of 44 patients with substance use disorders (SUD) undergoing prolonged exposure therapy for PTSD, there were no significant increases in substance craving or use during therapy sessions, except for a slight increase in cocaine craving during one session.

The therapy led to a decrease in PTSD symptoms and emotional distress over time, suggesting that exposure therapy is safe and effective for SUD patients without exacerbating their substance use or other psychiatric issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Prolonged Exposure on Substance Use in Patients With Posttraumatic Stress Disorder and Substance Use Disorders. Peirce, JM., Schacht, RL., Brooner, RK.[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]

A 2-week intensive outpatient program (IOP) for PTSD involving daily prolonged exposure therapy showed high retention rates (91%) and significant reductions in PTSD and depression symptoms among 376 veterans and military service members.

Long-term follow-up indicated that while there were small increases in symptoms after 3 months, large reductions in PTSD and depression were maintained up to 12 months, highlighting the lasting effectiveness of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a prolonged exposure-based intensive outpatient program for veterans with posttraumatic stress disorder. Yasinski, CW., Watkins, LE., Maples-Keller, JL., 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]

Writing disclosure (WD) treatment, based on Pennebaker's method, significantly reduced PTSD symptoms in 45 substance use disorder inpatients, showing promise as an effective intervention.

The symptom reductions observed after WD treatment were stable at a 3-month follow-up, indicating potential long-term benefits and cost-effectiveness for treating PTSD in individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written disclosure treatment for posttraumatic stress disorder in substance use disorder inpatients. Bragdon, RA., Lombardo, TW.[2012]

The COPE treatment, which integrates prolonged exposure therapy with usual care, significantly reduced PTSD symptoms in patients with both PTSD and substance dependence, showing a mean difference of -16.09 points compared to usual treatment alone.

Importantly, the COPE treatment did not lead to an increase in substance dependence severity, indicating that it is a safe and effective option for treating individuals with co-occurring PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial. Mills, KL., Teesson, M., Back, SE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11809123/

A pilot study of twice-weekly group-based written exposure ... Findings demonstrate that brief, group-delivered WET is feasible and shows promise for addressing PTSD and depressive symptoms in residential SUD treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05536908

Evaluating Supplementing Residential Substance Use ... This project is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD.

3. 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), ...

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

Written Exposure Therapy vs Prolonged ... Findings In this randomized clinical trial of 178 veterans diagnosed with PTSD, participants in both treatments improved significantly, with ...

5. 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 ...

6. 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 ...