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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone, with suicide attempt rates three times higher for Veterans with alcohol use disorder and PTSD (Norman, Haller, Hamblen, Southwick \& Pietrzak, 2018). For patients with PTSD-SUD, there is evidence of greater PTSD symptom severity and poorer SUD treatment outcomes (e.g., Back et al., 2000), as well as higher rates of homelessness and disability (Bowe \& Rosenheck, 2015). PTSD-SUD treatments have shown promising reductions in PTSD and SUD symptoms (Flanagan, Korte, Killeen \& Back,2016). Yet, there are still major challenges in widely implementing concurrent or single-target gold-standard treatments for this population, especially with rural veterans where care access may be limited (e.g., Flanagan et al., 2016). Written Exposure Therapy (WET) is a front-line, brief and effective treatment for PTSD that addresses some of the challenges posed by other gold-standard treatments. This project is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD while they are completing a 28 day-residential SUD program (DOM SUD). The preliminary effects of the treatment during the program, and at one month and 3-month follow-up periods will also be examined, with particular attention to rates of substance use, homelessness, treatment attendance, treatment completion, quality of life, suicidality, and PTSD and depression symptoms. Veterans enrolled in the residential substance use disorder clinic will be recruited for screening into the study. Those that meet criteria for PTSD will be randomized into one of two treatment arms: Treatment as Usual (TAU: DOM SUD) and Written Exposure Therapy in a residential SUD program (resWET). Those in the TAU control group will participate in the DOM SUD treatment program, while those in the resWET group will also have five individual treatment sessions of WET. Participants will complete weekly measures of symptoms, in addition to rating cravings for substance use. Treatment completion rates will also be compiled for both DOM SUD and resWET. Participants will complete pre-treatment, post-treatment, 1 month, and 3 month follow-up measures to look for important trends regarding symptom responses to treatment (e.g., PTSD, depression), as well as suicide attempts, homelessness, treatment attendance, treatment completion, substance use, and quality of life. This preliminary data will be used to inform future studies. Additionally, providers will provide feedback to provide essential information about implementation barriers that need to be addressed for the broader uptake of the treatment approach and to enhance accessibility of the treatment. All Veterans will also provide feedback about their treatment. Findings will be used to improve the treatment and assessment approach and to prepare for a larger study to evaluate resWET.

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.

What data supports the idea that Written Exposure Therapy for PTSD and Substance Use Disorders is an effective treatment?

The available research shows that Written Exposure Therapy (WET) is effective for treating PTSD. One study found that WET was just as effective as Cognitive Processing Therapy (CPT) in reducing PTSD symptoms over a long period, up to 60 weeks. This suggests that WET can be a good alternative to other therapies. Additionally, WET is brief and has low dropout rates, making it a practical option for many people. While the research does not directly compare WET to treatments for substance use disorders, it highlights WET's effectiveness for PTSD, which often co-occurs with substance use issues. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Written Exposure Therapy for PTSD and Substance Use Disorders?

Research shows that Written Exposure Therapy (WET) is effective for PTSD, with outcomes similar to Cognitive Processing Therapy, and it maintains treatment gains over time. Additionally, exposure-based therapies like WET have been shown to reduce PTSD symptoms without increasing substance use in patients with co-occurring substance use disorders. ^{1 2 3 4 5}

What safety data exists for Written Exposure Therapy for PTSD and Substance Use Disorders?

Written Exposure Therapy (WET) is generally considered safe for treating PTSD, even in individuals with co-occurring substance use disorders. Studies indicate that WET has low treatment dropout rates and is associated with minimal adverse events. For example, a study comparing trauma-focused and nontrauma-focused interventions found no significant difference in adverse events, suggesting that implementing PTSD treatment in substance abuse programs is safe. Additionally, WET has shown non-inferior outcomes compared to Cognitive Processing Therapy, with maintained treatment gains and low risk of negative consequences. ^{1 4 6 7 8}

Is Written Exposure Therapy safe for people with PTSD and substance use disorders?

Research suggests that Written Exposure Therapy (WET) is generally safe for people with PTSD, including those with substance use disorders. Studies have shown low rates of adverse events (unwanted side effects) and minimal impact on psychiatric and substance abuse symptoms when PTSD treatments are implemented in substance abuse programs. ^{1 4 6 7 8}

Is Treatment as Usual a promising treatment for PTSD and Substance Use Disorders?

The information provided does not specifically address the effectiveness of Treatment as Usual for PTSD and Substance Use Disorders. However, Written Exposure Therapy (WET) is highlighted as a promising treatment for PTSD, offering benefits like fewer sessions, shorter time commitment, and significant symptom improvement. WET is efficient and well-tolerated, making it a strong option for treating PTSD. ^{1 4 6 9 10}

How is Written Exposure Therapy different from other treatments for PTSD and Substance Use Disorders?

Written Exposure Therapy (WET) is unique because it is a brief treatment consisting of only five sessions, requires no homework between sessions, and has shown to be effective in reducing PTSD symptoms. This makes it more efficient and accessible compared to other longer and more intensive therapies. ^{1 4 6 9 10}

Research Team

Dana Holohan

Principal Investigator

Salem VA Medical Center, Salem, VA

Eligibility Criteria

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

I am currently experiencing a manic episode.

Current Suicidal Intent

Previous Written Exposure treatment

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a prolonged exposure-based intensive outpatient program for veterans with posttraumatic stress disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. [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

The Effects of Prolonged Exposure on Substance Use in Patients With Posttraumatic Stress Disorder and Substance Use Disorders. [2021]

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

Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial. [2022]

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

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. [2021]

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

Written disclosure treatment for posttraumatic stress disorder in substance use disorder inpatients. [2012]

9. 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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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