WET + EFST for PTSD During Pregnancy
(TAPS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University
Disqualifiers: Psychosis, Unstable bipolar, Incarceration, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12345How 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.
678910Eligibility 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
+1 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Written Exposure Therapy (WET)Experimental Treatment1 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 Treatment1 Intervention
Participants randomized into this arm will receive the WET intervention administered by community health workers.
Group III: Emotion Focused Supportive Therapy (EFST)Active Control1 Intervention
Participants randomized into this arm will receive the EFST intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Medical Center and remoteBoston, MA
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Who Is Running the Clinical Trial?
Boston UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Brief novel therapies for PTSD: Written Exposure Therapy. [2022]Written Exposure Therapy (WET) is a 5-session exposure-based intervention for the treatment of posttraumatic stress disorder (PTSD). WET was developed through a series of systematic evaluations of the expressive writing procedure. It is an efficient intervention, requiring limited patient and therapist time and no between-session assignments. The treatment results in statistically and clinically significant symptom change among individuals, including veterans, with PTSD.
An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. [2021]Written exposure therapy (WET) is exposure therapy for post-traumatic stress disorder (PTSD). Compared to evidencebased treatments for PTSD, WET requires only five sessions, has a shorter session time, and no between-session assignments. The current study examined the efficacy of WET among Korean patients with PTSD due to various traumatic events on PTSD symptoms, depressive symptoms, and global functioning levels.
Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2023]Evidence-based treatments for posttraumatic stress disorder (PTSD) exist, but all require 8 to 15 sessions and thus are less likely to be completed than brief treatments. Written exposure therapy (WET) is a brief and efficacious treatment that has not been directly compared with prolonged exposure therapy (PE), a more time-intensive, exposure-based treatment.
Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]Written exposure therapy (WET) is a 5-session PTSD treatment that may address barriers in treatment for posttraumatic stress disorder (PTSD) given its brevity and tolerability. A recent study found outcomes for WET were non-inferior to outcomes from Cognitive Processing Therapy (CPT) through 36 weeks from first treatment session (Sloan, Marx, Lee, & Resick, 2018); the current study examined whether treatment gains were maintained through 60 weeks from first session, and also evaluated both treatments' effect on depressive symptoms.
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]This pilot open trial examined the feasibility, acceptability, and preliminary effectiveness of Written Exposure Therapy (WET), a 5-session evidence-based intervention for posttraumatic stress disorder (PTSD) during pregnancy. Participants were pregnant women with comorbid PTSD and substance use disorder (SUD) receiving prenatal care in a high risk obstetrics-addictions clinic.
Surfactant sufficiency for immature infants--prenatal induction vs. postnatal treatment. [2008]The prenatal and postnatal therapeutic management of surfactant insufficiency are reviewed. Prenatal maternal glucocorticoid therapy promotes lung maturation and enhances lung surfactant levels in the neonate, but a minimum of 24 hr treatment is required and the therapy is of limited effectiveness even under optimal conditions. Relatively few women in premature labour are good candidates for glucocorticoid therapy. Research into combinations of glucocorticoids with hormones (e.g. thyroid), and adrenergic agents in progress. The authors are studying the effects of fibroblast-pneumonocyte factor (FPF) on the fetal lung surfactant system. Postnatal therapy with insufflated natural and artificial surfactants has been studied in several centres with varying degrees of success. Currently, the risk:benefit ratios favour attempts to reduce the risks of respiratory distress syndrome (RDS) by both prenatal surfactant induction and postnatal replacement therapy. Greater understanding of the underlying mechanisms should permit the establishment of more satisfactory treatment.
Sedation of newborn infants for the INSURE procedure, are we sure? [2021]Neonatal intubation is a stressful procedure that requires premedication to improve intubation conditions and reduce stress and adverse physiological responses. Premedication used during the INSURE (INtubation, SURfactant therapy, Extubation) procedure should have a very short duration of action with restoration of spontaneous breathing within a few minutes.
Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach. [2021]Despite antenatal corticosteroids therapy, respiratory distress syndrome (RDS) is still a leading cause of neonatal morbidity and mortality in premature newborns. To date, the relationship between in utero fetal drug exposure and occurrence of RDS remains poorly evaluated. This study aims to describe the pharmacokinetics of betamethasone in pregnant women and to evaluate the transplacental drug transfer and administration scheme for the prevention of RDS. Pregnant women > 27 weeks' gestation and who received at least a single dose of betamethasone for prevention of RDS were enrolled. Maternal, cord blood, and amniotic fluid betamethasone time-courses were analyzed using the Monolix software. A total of 220 maternal blood, 56 cord blood, and 26 amniotic fluid samples were described by a two-compartment model with two effect compartments linked by rate transfer constants. Apparent clearances and volumes of distribution parameters were allometrically scaled for a 70 kg third trimester pregnant woman. The impact of a twin pregnancy was found to increase maternal clearance by 28%. Using a fetal-to-mother exposure ratio, the median (95% confidence interval (CI)) transplacental transfer of betamethasone was estimated to 35% (95% CI 0.11-0.67). After adjustment for gestational age and twin pregnancy, RDS was found to be associated to the time spent in utero below quantifiable concentrations (i.e.,
ACOG committee opinion. Antenatal corticosteroid therapy for fetal maturation. American College of Obstetricians and Gynecologists. [2016]The National Institute of Child Health and Human Development and the Office of Medical Applications of Research of the National Institutes of Health convened consensus conferences in 1994 and 2000 that recommended giving a single course of corticosteroids to all pregnant women between 24 and 34 weeks of gestation who are at risk of preterm delivery within 7 days. Because of insufficient scientific evidence, the consensus panel also recommended that repeat corticosteroid courses, including so-called "rescue therapy," should not be routinely used but should be reserved for women enrolled in clinical trials. Betamethasone and dexamethasone have been most widely studied and have generally been the preferred corticosteroids for antenatal treatment to accelerate fetal organ maturation. The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice supports the conclusions of the consensus conferences.
ACOG committee opnion: antenatal corticosteroid therapy for fetal maturation. [2019]The National Institute of Child Health and Human Development and the Office of Medical Applications of Research of the National Institutes of Health convened consensus conference in 1194 and 2000 that recommended giving a single course of corticosteriods to all pregnant women between 24 and 34 weeks of gestation who are at risk of preterm delivery within 7 days. Because of insufficient scientific evidence, the consensus panel also recommended that repeat corticosteroid courses, including so-called "rescue therapy," should not be routinely used but should be reserved for women enrolled in clinical trials. Betamethasone and dexamethasone have been most widely studied and have generally been the preferred corticosteroids for antenatal treatment to accelerate fetal organ maturation. The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice supports the conclusions of the consensus conferences.