Written Exposure Therapy for PTSD

Overseen By Andrea A Massa, PhD

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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Written Exposure Therapy (WET) for PTSD?

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 is as effective as longer therapies like Cognitive Processing Therapy (CPT) and Prolonged Exposure Therapy (PE), making it a practical option for many patients. ^{1 2 3 4 5}

Is Written Exposure Therapy (WET) safe for humans?

Written Exposure Therapy (WET) is generally considered safe for treating PTSD, as it is a brief and tolerable treatment that has been tested in various clinical 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 requires only five sessions, has shorter session times, and does not involve homework between sessions, making it more efficient and accessible compared to other PTSD treatments that typically require 8 to 15 sessions. ^{1 2 3 4 5}

What is the purpose of this trial?

The main objective of this pilot trial is to determine the feasibility and initial efficacy of telehealth-delivered written exposure therapy to reduce the development of posttraumatic stress disorder after sexual assault. This pilot trial will provide the data necessary to design and support a large-scale trial.

Research Team

Samuel A McLean, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

Pregnant

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

Incarcerated or in police custody

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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) 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]

References

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

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

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. 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]