Written Exposure Therapy for Perinatal PTSD

(EMPWR Trial)

Overseen By Virgilio Garza, B.S.

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Cognitive impairment, Psychosis, Suicidal risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.

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's best to discuss this with the study team or your doctor.

Is Written Exposure Therapy safe for humans?

Written Exposure Therapy (WET) is generally considered safe for humans, as it has been used in various studies for treating posttraumatic stress disorder (PTSD) and has shown to be well-tolerated by participants, including veterans and pregnant women with PTSD. ^{1 2 3 4 5}

How is Written Exposure Therapy different from other treatments for perinatal PTSD?

Written Exposure Therapy (WET) is unique because it is a brief, 5-session treatment that doesn't require homework between sessions, making it more efficient and accessible compared to other PTSD therapies. It has been shown to be effective in reducing PTSD symptoms, even among pregnant women with additional challenges like substance use disorder. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Written Exposure Therapy for perinatal PTSD?

Written Exposure Therapy (WET) has been shown to be effective for treating PTSD in various groups, including veterans and individuals with different traumatic experiences. It is a brief, 5-session treatment that has demonstrated significant improvements in PTSD symptoms and is comparable to other established therapies like Cognitive Processing Therapy. ^{1 2 3 4 5}

Who Is on the Research Team?

Nabila Haque, MD., PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum adolescents and youth aged 15-24 with PTSD or subthreshold PTSD. Participants must be referred by a clinician, able to read and write in English or Spanish, willing to follow study procedures, and have parental consent if under 18. Excluded are those with conditions that could affect the study's outcome like cognitive impairments, current mania/psychosis, substantial developmental disorders, recent exposure-based therapy, or serious suicidal risk.

Inclusion Criteria

Referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up

Able to read, write and speak in English and Spanish; if the participant is under age 18, parents must be able to understand spoken or written English or Spanish

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments

I am currently experiencing mania, hypomania, or psychosis.

Pervasive or intellectual developmental disorder requiring substantial or very substantial support

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants complete 5 sessions of Written Exposure Therapy, one session per week, with biomarker data collection via a wearable device

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms, sleep quality, emotional regulation, and anxiety at 4, 8, and 12 weeks post-baseline

12 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Written Exposure Therapy

Trial Overview The trial studies Written Exposure Therapy (WET) for treating PTSD in perinatal adolescents. It aims to determine how feasible and acceptable WET is as a treatment option during pregnancy or within one year postpartum.

How Is the Trial Designed?

Group I: Written Exposure Therapy Experimental Treatment 1 Intervention

All participants will receive written exposure therapy

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Texas Child Mental Healthcare Consortium (TCMHCC)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Written Exposure Therapy (WET) significantly reduced PTSD symptoms in pregnant women, with improvements lasting up to 6 months postpartum, indicating its potential effectiveness for this population.

The intervention was found to be feasible and acceptable, with high participant satisfaction and strong therapist adherence to the treatment protocol, suggesting it could be a viable option for managing PTSD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Nillni, YI., Baul, TD., Paul, E., 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) 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) 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, 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 for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. [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. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

6. 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]