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 trial tests Written Exposure Therapy (WET), a type of writing therapy, to determine its effectiveness in reducing PTSD symptoms in pregnant and postpartum young people. The researchers aim to assess whether this therapy is practical and well-received by participants. It targets individuals who are pregnant or have given birth within the past year and are experiencing PTSD symptoms. Participants must be able to read and write in English or Spanish and have been referred by a clinician for pregnancy-related care. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance mental health care for pregnant and postpartum individuals.

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.

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

Research has shown that Written Exposure Therapy (WET) is generally safe for treating PTSD. Studies have found that it can significantly reduce PTSD symptoms, even months after treatment ends. The available data reports no serious side effects or safety issues. In general, exposure therapy, such as WET, is well-tolerated, particularly because it uses writing exercises instead of medication. This method has also been used successfully during pregnancy, indicating safety for both the mother and the baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy (WET) for perinatal PTSD because it offers a unique approach compared to traditional treatments like cognitive behavioral therapy (CBT) and medication. Unlike these standard options, which often require lengthy sessions or involve pharmaceuticals, WET is a brief, non-pharmacological intervention that involves writing about traumatic experiences over a few sessions. This method could be more accessible and appealing to new mothers who may have time constraints or concerns about medication. Furthermore, WET aims to directly process and reduce trauma-related symptoms by transforming how individuals understand and emotionally respond to their traumatic experiences, potentially offering quicker relief.

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

Research has shown that Written Exposure Therapy (WET) effectively treats PTSD in pregnant and postpartum individuals. Studies have found that PTSD symptoms significantly decreased from before to after the therapy, with improvements lasting for at least six months. Participants also find WET practical and acceptable, making it a promising option. This therapy could be especially useful in areas with limited resources, as it helps overcome many common barriers to treatment. ^{1 2 4 6 7}

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 (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 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) 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, 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) 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587907/

Written exposure therapy for treatment of perinatal PTSD ... Conclusions: WET was a feasible and acceptable treatment for PTSD in this sample. Randomized clinical trial studies with a general group of pregnant women are ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834323000713

Written exposure therapy for treatment of perinatal PTSD ... PTSD symptoms significantly decreased from pre-intervention to post-intervention (S = 26.6, p = 0.006), which sustained at the 6-month postpartum follow-up (S = ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06771817

Empowering Perinatal Adolescents Through Writing WET may be an optimal treatment for pregnant or postpartum adolescents and youth with PTSD in a low resource setting. WET addresses many of the barriers above.

4. link.springer.com link.springer.com/article/10.1007/s40615-024-02203-w

A Pilot Study Exploring the Feasibility of Virtual Written ... In this study, we explored the initial feasibility of the virtual delivery of WET to reduce PTSD symptoms among Black perinatal women.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37119780/

Written exposure therapy for treatment of perinatal PTSD ... This pilot open trial examined the feasibility, acceptability, and preliminary effectiveness of Written Exposure Therapy (WET), a 5-session evidence-based ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05486793

Treatment for Antepartum Posttraumatic Stress Disorder ... Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., ...

7. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-020-00503-4

Exposure therapy for PTSD during pregnancy: a feasibility ... Conclusions. Results suggest that a brief exposure therapy PTSD treatment can be successfully implemented during pregnancy, suggesting promising ...