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

NCT07060144 | Recruiting

• 1 other identifier: 00006641
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Pregnancy

Keywords

PTSD; pregnancy; cognitive processing therapy; psychotherapy; trauma

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure. Higher scores reflect greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity. PCL-5 Monthly will be collected at Visit 1, and the PCL-5 weekly will be collected at 1 week, 4 weeks, 8 weeks, 12 weeks, and 16 weeks following initiation of treatment in both groups.

  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

Secondary Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  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

• Prenatal Attachment Inventory (PAI)

  Baseline

• Maternal Attachment Inventory (MAI)

  Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)

• Infant CARE-Index (CARE-Index)

  Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)

Study Arms (2)

Regular CPT

EXPERIMENTAL

Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total

Behavioral: Regular CPT

mCPT

EXPERIMENTAL

Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)

Behavioral: Massed CPT

Interventions

Regular CPT BEHAVIORAL

Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total

Regular CPT

Massed CPT BEHAVIORAL

Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)

mCPT

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (\> 4x weekly)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin, Dell Medical School, Department of Psychiatry

Austin, Texas, 78701, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Erin Richardson

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Associate I

CONTACT

512-766-6209; ambreen.rana@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Nurse

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)