RecruitingNot Applicable

Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)

United States60 participantsStarted 2025-08-01

Plain-language summary

Pregnant women with a primary diagnosis of posttraumatic stress disorder (PTSD) (PTSD Checklist for DSM-5 (PCL-5) score \> 33) will be randomized to receive conventional cognitive processing therapy (CPT) (60-min session once/week for 12 weeks) or massed CPT (mCPT) (an intensive schedule of 12 60-min sessions over 5 days, approximately 2-3 sessions per day) via telemedicine, for treatment of PTSD. The research aims will be three-fold: (1) Evaluate the relative efficacy and tolerability of CPT vs. mCPT for treatment of perinatal PTSD and depression; (2) Determine the effect of CPT upon maternal-infant attachment and interaction; (3) Collect pilot data of obstetric and neonatal outcomes among those receiving the two CPT delivery schedules.

Who can participate

Age range

18 Years – 46 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female, ages 18-46, Pregnant (\< 25 weeks), able to read and write in English, History of at least 1 criterion A trauma, Primary diagnosis of PTSD (confirmed by SCID), Psychotropic medications must be stable with no changes ≥ 2 weeks (≥ 6 weeks for fluoxetine), and no medication changes can be made during the course of therapy Exclusion Criteria: * Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (\> 4x weekly)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses Cognitive Processing Therapy specifically for PTSD during pregnancy — can you help me understand whether my PTSD symptoms and pregnancy situation match what this study is designed for, and whether this timing feels safe and appropriate for me?
2Since this trial is listed as Phase NA, which often means it's studying a behavioral therapy rather than a drug, what do we already know about the safety and effectiveness of Cognitive Processing Therapy for people who are pregnant or recently postpartum?
3The trial is measuring PTSD symptoms using a questionnaire called the PCL-5 — does that mean the main goal is to see if symptoms improve over time, and how would my progress actually be tracked and shared with my regular care team?
4Given that I'm pregnant or recently postpartum, what would the time commitment and session schedule for this therapy look like, and is it realistic to manage alongside prenatal or postnatal appointments and everything else that comes with this stage?
5Are there standard treatment options for perinatal PTSD that I should consider first, or discuss alongside this trial, so I can make a fully informed decision about what path makes the most sense for me and my baby?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

Timeframe: Baseline, then at 1 week, 4 weeks, 8 weeks, 12 weeks, and 16 weeks following initiation of treatment in both the mCPT and traditional CPT groups

Trial details

NCT IDNCT07060144

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Research Associate I

512-766-6209 ambreen.rana@austin.utexas.edu

View on ClinicalTrials.gov More Posttraumatic Stress Disorder (PTSD) trials