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

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT07060144
Status
Recruiting

Conditions

  • Posttraumatic Stress Disorder (PTSD)
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 46 Years
Healthy Volunteers
Not accepted

Interventions

  • Regular CPT — BEHAVIORAL
    Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total
  • Massed CPT — BEHAVIORAL
    Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regular CPT
    Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total
  • Experimental: mCPT
    Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)

Primary Outcome Measure

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at Austin, Dell Medical School, Department of PsychiatryAustinTexas78701-

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