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Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
NCT07060144 · University of Texas at Austin
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility 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)
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2025-07
Estimated completion: 2026-12
Last updated: 2025-07-11
Interventions
Behavioral: Regular CPTBehavioral: Massed CPT
Primary outcomes
- • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) (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)
Sponsor
University of Texas at Austin · other
Contacts & investigators
ContactResearch Associate I · contact · ambreen.rana@austin.utexas.edu · 512-766-6209
InvestigatorErin Richardson · principal_investigator, University of Texas at Austin
All locations (1)
University of Texas at Austin, Dell Medical School, Department of PsychiatryRecruiting
Austin, Texas, United States