NCT07060144 · University of Texas at Austin
Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
What this study is about
Pregnant women with a primary diagnosis of posttraumatic stress disorder (PTSD) (PTSD Checklist for DSM-5 (PCL-5) score \> 33) will be randomly assigned 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 effectiveness 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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Austin, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations