WET + EFST for PTSD During Pregnancy

(TAPS Trial)

Overseen By Hannah Brown, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Psychosis, Unstable bipolar, Incarceration, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving exposure-based PTSD treatment elsewhere, you would not be eligible to participate.

What data supports the effectiveness of this treatment for PTSD during pregnancy?

Written Exposure Therapy (WET) has been shown to significantly reduce PTSD symptoms in various populations, including veterans and pregnant women with PTSD and substance use disorder. It is a brief, efficient treatment that has demonstrated similar effectiveness to longer therapies, making it a promising option for treating PTSD during pregnancy. ^{1 2 3 4 5}

Is Written Exposure Therapy (WET) safe for humans?

Written Exposure Therapy (WET) has been studied in various groups, including pregnant women with PTSD and substance use disorder, and has shown to be a brief and tolerable treatment. It has been compared to other PTSD treatments and found to be effective without significant safety concerns. ^{1 2 3 4 5}

How is Written Exposure Therapy (WET) unique for treating PTSD during pregnancy?

Written Exposure Therapy (WET) is unique because it involves writing about traumatic experiences in a structured way, which can be less intimidating and more accessible than traditional talk therapy. This approach allows pregnant women to process trauma at their own pace, potentially reducing stress without the need for medication. ^{6 7 8 9 10}

What is the purpose of this trial?

The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.

Research Team

Yael I Nillni, PhD

Principal Investigator

BUSM Department of Psychiatry and VA Boston Healthcare System

Eligibility Criteria

This trial is for pregnant women under 28 weeks gestation, receiving prenatal care at BMC OB/GYN Department, who meet criteria for PTSD or have significant symptoms. It's not suitable for those needing inpatient care, with current psychosis or unstable bipolar disorder, already undergoing specific PTSD treatments elsewhere, or incarcerated individuals.

Inclusion Criteria

Pregnant woman receiving prenatal care at BMC OB/GYN Department

Presenting for prenatal care prior to gestational age of 28 weeks

I have been diagnosed with PTSD or show significant symptoms of it.

Exclusion Criteria

Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)

Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)

Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 sessions of Written Exposure Therapy (WET) or Emotion Focused Supportive Therapy (EFST) during pregnancy

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for PTSD symptom severity and other psychological symptoms at multiple postpartum intervals

12 months

Assessments at 1, 6, and 12 months postpartum

Treatment Details

Interventions

• Emotion Focused Supportive Therapy (EFST)
• Written Exposure Therapy (WET)

Trial Overview The study tests the effectiveness of Written Exposure Therapy (WET) for perinatal PTSD and compares its delivery by community health workers versus mental health clinicians. This randomized controlled trial aims to address treatment accessibility and evaluate a brief evidence-based intervention within usual obstetrics settings.

Participant Groups

Group I: Written Exposure Therapy (WET) Experimental Treatment 1 Intervention

Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.

Group II: Community Health Workers- Written Exposure Therapy (CHW-WET) Experimental Treatment 1 Intervention

Participants randomized into this arm will receive the WET intervention administered by community health workers.

Group III: Emotion Focused Supportive Therapy (EFST) Active Control 1 Intervention

Participants randomized into this arm will receive the EFST intervention.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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 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) 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) 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 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]

Prenatal glucocorticoid therapy can help mature the lungs and increase surfactant levels in newborns, but it requires at least 24 hours of treatment and is not always effective, especially since not all women in premature labor are suitable candidates.

Postnatal treatments using natural and artificial surfactants have shown varying success, but current evidence suggests that both prenatal and postnatal therapies are beneficial in reducing the risks of respiratory distress syndrome (RDS) in neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surfactant sufficiency for immature infants--prenatal induction vs. postnatal treatment. Taeusch, HW., Smith, BT.[2008]

A systematic review of 12 studies on premedication for neonatal intubation during the INSURE procedure found that both propofol and remifentanil provided good intubation conditions with an average extubation time of about 20 minutes.

However, the review highlighted a lack of sufficient data on other common sedatives like fentanyl and morphine, indicating that more research is needed to determine the safest and most effective premedication for newborns of varying gestational ages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedation of newborn infants for the INSURE procedure, are we sure? de Kort, EH., Reiss, IK., Simons, SH.[2021]

The study analyzed the pharmacokinetics of betamethasone in pregnant women and found that the transplacental transfer of the drug is approximately 35%, which is crucial for its effectiveness in preventing respiratory distress syndrome (RDS) in premature newborns.

It was determined that the time spent in utero with betamethasone concentrations below 1 ng/mL is associated with an increased risk of RDS, suggesting that maintaining adequate drug levels is important for reducing neonatal morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach. Foissac, F., Zheng, Y., Hirt, D., et al.[2021]

Corticosteroids, specifically betamethasone and dexamethasone, are recommended for pregnant women between 24 and 34 weeks of gestation who are at risk of preterm delivery, as they help accelerate fetal organ maturation.

The consensus panels advised against routine repeat courses of corticosteroids, suggesting they should only be used in clinical trials due to insufficient evidence for their safety and efficacy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG committee opinion. Antenatal corticosteroid therapy for fetal maturation. American College of Obstetricians and Gynecologists. [2016]

A single course of corticosteroids, such as betamethasone or dexamethasone, is recommended for pregnant women between 24 and 34 weeks of gestation who are at risk of preterm delivery, as it helps accelerate fetal organ maturation.

Repeat courses of corticosteroids, or 'rescue therapy,' should not be routinely used and are only recommended for women participating in clinical trials due to insufficient evidence supporting their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG committee opnion: antenatal corticosteroid therapy for fetal maturation. [2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

6. Denmark pubmed.ncbi.nlm.nih.gov

Surfactant sufficiency for immature infants--prenatal induction vs. postnatal treatment. [2008]

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

Sedation of newborn infants for the INSURE procedure, are we sure? [2021]

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

Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach. [2021]

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

ACOG committee opinion. Antenatal corticosteroid therapy for fetal maturation. American College of Obstetricians and Gynecologists. [2016]

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

ACOG committee opnion: antenatal corticosteroid therapy for fetal maturation. [2019]