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

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive re-experiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus \& Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother \& Rachman, 2004; Radomsky \& Elliott, 2009). Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination. Written Exposure Therapy (WET) is a five-session treatment for PTSD that was designed to be both brief and easy to administer (Sloan et al., 2012). According to Sloan and colleagues' (2012) protocol, sessions broadly involve 30-minute exposures in which the patient writes about the events of their trauma in detail, followed by 10 minutes of discussing the exposure with the therapist. This treatment protocol has minimal therapist involvement, no homework assignments, and shorter treatment sessions. Research shows that WET is efficacious among different samples (e.g., survivors of motor vehicle accidents and combat veterans), has low dropout rates, treatment satisfaction is high, and the gains seen by participants after completion are maintained at follow-up (Sloan et al., 2012, 2013, 2018; Thompson-Hollands et al., 2018, 2019). Given these factors, WET has the potential to be a useful intervention in reducing symptoms of PTSD among a sample of survivors of sexual trauma. Given its relevance to this trauma population, a test of this intervention for its impact on reducing trauma-related mental contamination is also needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: Explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 5 sessions of WET. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.

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.

Is Written Exposure Therapy (WET) safe for humans?

Written Exposure Therapy (WET) is generally considered safe for humans, as it is a brief and tolerable treatment for post-traumatic stress disorder (PTSD) that has been studied in various trials without reports of significant safety concerns. ^{1 2 3 4 5}

How is Written Exposure Therapy different from other PTSD treatments?

Written Exposure Therapy (WET) is unique because it is a brief treatment requiring only five sessions, with no homework between sessions, making it more time-efficient and easier to complete compared to other PTSD treatments that typically require 8 to 15 sessions. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Written Exposure Therapy (WET) for Post-Traumatic Stress Disorder?

Research shows that Written Exposure Therapy (WET) is effective for treating PTSD, with significant symptom improvement in patients, including veterans. It is a brief treatment that has been found to be as effective as longer therapies like Cognitive Processing Therapy, with benefits lasting up to 60 weeks. ^{1 2 3 4 7}

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 (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) 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) 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]

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, 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]

Citations

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

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2023]

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

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]

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

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. [2022]

7. 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]