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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women with PTSD (post-traumatic stress disorder) by testing a therapy called Written Exposure Therapy (WET). The study will compare the effectiveness of WET when delivered by mental health clinicians versus community health workers and will also test another therapy called Emotion Focused Supportive Therapy (EFST). Pregnant women who are less than 28 weeks along and have PTSD symptoms may be suitable candidates for this trial. The goal is to find accessible ways to treat PTSD during pregnancy, which can improve outcomes for both the mother and baby.

As an unphased trial, this study provides a unique opportunity to explore new therapeutic options for managing PTSD during pregnancy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Written Exposure Therapy (WET) for PTSD is practical and well-received, particularly for pregnant women. Studies have found WET to be a promising treatment during pregnancy, with no major side effects reported. Previous findings suggest that participants handle the therapy easily, with most completing it without major issues.

Similarly, researchers have studied Emotion Focused Supportive Therapy (EFST) for PTSD during pregnancy. Case studies have shown no side effects, and the treatment is considered likely safe. Overall, both therapies appear to be safe options for pregnant women dealing with PTSD, based on available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy (WET) and Emotion Focused Supportive Therapy (EFST) for PTSD during pregnancy because they offer new ways to tackle this condition. Unlike typical PTSD treatments like cognitive-behavioral therapy or medication, WET is a structured, short-term therapy that focuses on processing trauma through writing, potentially making it more accessible and less intimidating. EFST, on the other hand, emphasizes emotional support and understanding, which can be crucial during the vulnerable period of pregnancy. Together, these therapies aim to provide pregnant individuals with more tailored and supportive options for managing PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD during pregnancy?

This trial will compare Written Exposure Therapy (WET) and Emotion Focused Supportive Therapy (EFST) for treating PTSD during pregnancy. Studies have shown that WET effectively reduces PTSD symptoms. In one study, symptoms significantly decreased from before to after treatment, and this improvement lasted for six months after giving birth. Research also shows that WET works as well as other well-known therapies like Prolonged Exposure Therapy but with fewer participants dropping out. Meanwhile, EFST has shown promise in improving mental health and daily functioning for those with PTSD. Both therapies aim to relieve PTSD symptoms during pregnancy, which can help improve overall well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Yael I Nillni, PhD

Principal Investigator

BUSM Department of Psychiatry and VA Boston Healthcare System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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) 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]

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]

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]

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05486793

Treatment for Antepartum Posttraumatic Stress Disorder ... The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05486793/treatment-for-antepartum-posttraumatic-stress-disorder-ptsd-study

Treatment for Antepartum Posttraumatic Stress Disorder ... The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during ...

3. withpower.com withpower.com/trial/phase-post-traumatic-stress-disorder-ptsd-11-2022-d78ae

WET + EFST for PTSD During Pregnancy (TAPS Trial) 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6255986/

Effectiveness of Trauma-Focused Psychological Therapies for ... Results suggest that TFPT are effective for reducing PTSD symptoms in the short term (up to 3 months postpartum [4 RCTs, n = 301, SMD = −0.50, 95% CI = −0.73 to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0266613825001007

A scoping review of effective health practices for the ... The first session delivered early (within the first 72 h of birth) by a clinician (midwife/psychologist/counsellor) significantly reduced BT/CB-PTSD in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7473051/

The effects of PTSD treatment during pregnancy Despite the fact that case studies as the one presented here report no adverse events, and treatment is likely safe, due to the poor ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000578942500084X

A Feasibility and Acceptability Trial of Narrative Exposure ... Linear mixed models showed significant decreases in PTSD and depressive symptoms over time, with sustained symptom improvement extending into ...