Comparing weekly versus intensive cognitive processing therapy for pregnant women with PTSD
Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
This tests whether standard weekly cognitive processing therapy or an intensive five-day version delivered by telemedicine better helps pregnant women with PTSD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 46 Years |
| Sex | Female |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT07060144 on ClinicalTrials.gov |
What this trial studies
Pregnant participants under 25 weeks with a primary PTSD diagnosis are randomized to receive either conventional CPT (12 weekly 60-minute sessions) or massed CPT (12 60-minute sessions delivered over about 5 days) delivered via telemedicine. The trial compares symptom change in PTSD and depression, examines effects on maternal-infant attachment and interaction, and collects pilot obstetric and neonatal outcome data. Medications must be stable before and during therapy, and common exclusions include bipolar or psychotic disorders, active suicidal intent, substance use disorder, and frequent benzodiazepine use. The protocol is conducted through the University of Texas at Austin, Dell Medical School, with telehealth visits scheduled according to each treatment arm.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18–46 who are under 25 weeks gestation, fluent in English, have a primary PTSD diagnosis (PCL-5 >33 confirmed by SCID), and are on stable psychotropic medications if applicable.
Not a fit: People with bipolar disorder, psychotic disorders, active suicidal intent, substance use disorder, regular benzodiazepine use, or those who are not currently pregnant are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could show a faster or more convenient way to reduce PTSD symptoms in pregnancy and potentially improve maternal-infant bonding and short-term obstetric outcomes.
How similar studies have performed: Cognitive Processing Therapy is an established, evidence-based treatment for PTSD, and intensive or 'massed' CPT formats have shown promising results in other populations but have been less studied specifically during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Austin, Texas
- University of Texas at Austin, Dell Medical School, Department of Psychiatry — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Erin Richardson — University of Texas at Austin
- Study coordinator: Research Associate I
- Email: ambreen.rana@austin.utexas.edu
- Phone: 512-766-6209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.