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

NCT07060144 · University of Texas at Austin
In plain English

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