Written Exposure Therapy for Post-Traumatic Stress Disorder

Overseen By Jesse McCann, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jesse McCann

Must be taking: Psychotropic medications

Disqualifiers: Psychotic disorders, Dissociative identity, 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: 6

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Written Exposure Therapy (WET) can reduce PTSD symptoms and feelings of mental contamination (feeling dirty without physical contact) in individuals affected by sexual trauma. Participants will engage in five therapy sessions where they write about their trauma, a method that has shown promise in other PTSD cases, such as those involving car accidents and combat. The trial will include two groups, each starting with a different baseline period before therapy begins. Ideal participants are those with PTSD from sexual trauma who currently experience mental contamination and can write and speak English. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research in PTSD treatment.

Will I have to stop taking my current medications?

You can continue taking your current medications if they are psychotropic (affecting the mind) and you have been on a stable dose for at least 4 weeks before the study. You must also agree to keep the dosage stable during the study.

What prior data suggests that Written Exposure Therapy is safe for individuals with PTSD?

Research has shown that Written Exposure Therapy (WET) is a treatment for PTSD that most people can handle well. Studies indicate that few people drop out of WET, suggesting they find it manageable and not too difficult. Many participants report satisfaction with the treatment and continue to feel better over time.

In one study, a large number of participants no longer had PTSD after completing WET, suggesting its effectiveness and safety for those dealing with PTSD.

WET is designed to be short and simple. It involves writing about traumatic events in a structured way, with minimal therapist assistance. This method appears effective for many people without causing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Written Exposure Therapy (WET) is unique because it offers a streamlined approach to treating Post-Traumatic Stress Disorder (PTSD) by focusing on written expression over a compact schedule. Traditional PTSD treatments, like Cognitive Processing Therapy or Prolonged Exposure Therapy, often require many sessions and can be emotionally intense. WET, however, involves just five weekly sessions, making it potentially less burdensome and more accessible for patients. Researchers are excited about WET because it may provide similar benefits to existing therapies but in a shorter, more manageable format, which could lead to improved patient adherence and outcomes.

What evidence suggests that Written Exposure Therapy could be an effective treatment for PTSD?

Research has shown that Written Exposure Therapy (WET) effectively reduces PTSD symptoms in various groups, such as car accident survivors and combat veterans. Studies indicate that WET significantly lowers PTSD symptoms, with a strong impact on PTSD and a moderate impact on depression. WET is also known for low dropout rates and high participant satisfaction. In this trial, participants will be randomized to either a 3-week or 5-week baseline period before receiving WET. The treatment is brief, requiring only five sessions, and involves minimal therapist involvement. These factors suggest it could also help reduce PTSD symptoms related to sexual trauma, including feelings of mental contamination. ^{3 6 7 8 9}

Who Is on the Research Team?

Christal L Badour, PhD

Principal Investigator

University of Kentucky

Jesse McCann, MS

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults who have experienced sexual trauma, can read and write in English, and are currently dealing with PTSD symptoms and mental contamination. They must not be starting new trauma-related treatments or changing their stable psychotropic medication doses during the study.

Inclusion Criteria

I have been on a stable dose of my mental health medication for at least 4 weeks.

Patients must be willing to refrain from additional trauma-related treatment for the duration of the study.

I can speak, read, and write in English fluently.

Exclusion Criteria

Individuals who endorse factors for which the treatment being studied (WET) may be contraindicated; these factors may include having no or limited memory of the trauma that would prevent the individual from engaging in written exposures.

I do not have severe psychological conditions that require different treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone or virtual)

Baseline

Participants complete weekly assessments of PTSD symptoms and mental contamination

3-5 weeks

Weekly assessments (virtual)

Treatment

Participants receive 5 weekly sessions of Written Exposure Therapy (WET)

5 weeks

5 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in PTSD symptoms and mental contamination

4 weeks

Weekly assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Written Exposure Therapy

Trial Overview

The trial tests Written Exposure Therapy (WET), a brief treatment involving writing about one's traumatic experience over five sessions. The goal is to see if WET reduces PTSD symptoms and feelings of internal 'dirtiness' without physical contact, known as mental contamination.

How Is the Trial Designed?

Group I: 5-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 5-week baseline period with repeated weekly assessment after the initial intake. Following the 5-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.

Group II: 3-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 3-week baseline period with repeated weekly assessment after the initial intake. Following the 3-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.

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?

Jesse McCann

Lead Sponsor

Trials

2

Recruited

20+

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) 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 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 as effective as cognitive processing therapy (CPT) in treating PTSD, showing noninferior symptom reduction over time in a study of 126 participants.

WET requires significantly fewer sessions (5 sessions) compared to CPT (12 sessions) and resulted in lower dropout rates, suggesting it may be a more efficient treatment option for patients with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. Sloan, DM., Marx, BP., Lee, DJ., et al.[2022]

Written Exposure Therapy (WET) significantly reduced PTSD symptoms (effect size d = .84), depression symptoms (d = .47), and functional impairment (d = .36) in a study involving 277 veterans, demonstrating its effectiveness in a clinical setting.

The treatment was effective regardless of whether it was delivered in-person or via telehealth, with telehealth showing a lower dropout rate, suggesting it may be a more accessible option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. LoSavio, ST., Worley, CB., Aajmain, ST., 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]

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]

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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 ...

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