Written Exposure Therapy for PTSD

Overseen By Jasper Oliver, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Psychiatric medications

Disqualifiers: Pregnant, Incarcerated, Assaulted at work, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a type of writing therapy conducted over the phone can help prevent PTSD (post-traumatic stress disorder) in women following a sexual assault. Participants will either write about their experience in a structured manner or engage in neutral, unemotional writing. This small-scale study will assess whether this approach, known as Written Exposure Therapy (WET), merits further testing on a larger scale. Women who speak English, have recently experienced a sexual assault, and are open to remote therapy may be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could influence future PTSD treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot join if you've changed your psychiatric medications in the past month.

What prior data suggests that this therapy is safe for PTSD treatment?

Research shows that Written Exposure Therapy (WET) is generally safe for people with PTSD. Some studies indicate it is well-tolerated, even for those with other mood disorders or substance use issues. Most people do not experience serious side effects from this therapy. While it helps reduce PTSD symptoms, it requires minimal time with a therapist, making it easier for many to fit into their schedules.

Overall, WET has proven to be a safe option for many dealing with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy for PTSD because it offers a unique, efficient approach compared to traditional treatments like cognitive behavioral therapy and medication. This therapy involves just five sessions of writing exercises, which can be delivered remotely, making it more accessible and less time-consuming. Unlike other treatments that often focus on extensive verbal discussion, Written Exposure Therapy allows patients to process traumatic experiences through structured writing, potentially offering a more private and less intimidating option for those who find it challenging to open up in a face-to-face setting.

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

Research shows that Written Exposure Therapy (WET), which participants in this trial may receive, effectively treats PTSD. Studies have found it significantly reduces PTSD symptoms and has a strong impact. It also helps decrease depression symptoms. WET works as well as other longer therapies but has fewer participants discontinuing treatment. This makes WET a practical and efficient choice for managing PTSD symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Samuel A McLean, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a sexual assault and are at risk of developing post-traumatic stress disorder (PTSD). The details on specific inclusion and exclusion criteria are not provided, but typically these would involve age limits, the timeframe since the assault, mental health history, and other factors relevant to PTSD.

Inclusion Criteria

Meets PTSD risk score criteria

I have an email address.

I sought care within a week after experiencing a sexual assault.

Exclusion Criteria

History or condition that in investigator's judgment would likely make a participant non-compliant/unsuitable for participation, including deafness or blindness

Pregnant

Incarcerated or in police custody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive five sessions of remotely-delivered written exposure therapy or unemotional writing control

8 weeks

5 virtual sessions

Follow-up

Participants are monitored for changes in PTSD, pain, depressive, and somatic symptoms

5 months

Remote follow-ups via REDCap self-report surveys

What Are the Treatments Tested in This Trial?

Interventions

• Written Exposure Therapy

Trial Overview

The study is testing two different types of writing therapies delivered via telehealth: Unemotional Writing and Written Exposure Therapy. It aims to see if they can help prevent PTSD in those who've recently survived a sexual assault.

How Is the Trial Designed?

Group I: Written Exposure Therapy Experimental Treatment 1 Intervention

Five sessions of remotely-delivered written exposure therapy.

Group II: Unemotional Writing Placebo Group 1 Intervention

Five sessions of remotely-delivered non-emotional writing.

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?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Foundation of Hope, North Carolina

Collaborator

Trials

18

Recruited

670+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

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) 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) 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 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]

Citations

1.

ptsd.va.gov

ptsd.va.gov/professional/treat/txessentials/written_exposure_therapy.asp

Written Exposure Therapy for PTSD - National Center for PTSD

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), ...

2.

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 ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0005789424000297

State of the Science: Written Exposure Therapy for ...

The evidence indicates that WET is an efficacious and effective treatment approach for PTSD and is noninferior to more time-intensive evidence-based treatments ...

4.

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 ...

5.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ...

Studies have also shown that WET is noninferior to CPT, with significantly fewer treatment dropouts. Moreover, PTSD symptom severity, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8390941/

An Open Pilot Trial of Written Exposure Therapy ...

Written exposure therapy (WET) is exposure therapy for post-traumatic stress disorder (PTSD). Compared to evidence-based treatments for PTSD, WET requires ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S245186542100065X

Comparing written exposure therapy to Prolonged ...

In an ongoing randomized controlled trial (RCT) we are investigating whether WET is non-inferior in treating PTSD compared with the more time intensive PE.

8.

tandfonline.com

tandfonline.com/doi/full/10.1080/20008066.2025.2545048

Full article: Feasibility of written exposure therapy for PTSD ...

Average therapist time required was under six hours per patient. Within-group analyses showed significant reductions in PTSD symptoms at one-month follow-up (d ...