Recruiting

CPT vs. mCPT

Sponsor:

University of Texas at Austin

Code:

NCT07060144

Conditions

Posttraumatic Stress Disorder (PTSD)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 46

Healthy Volunteers: Not accepted

Interventions

Regular CPT

Massed CPT

Study Details

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

Study ID

NCT07060144

Start date

Aug 1, 2025

Status verified date

Jun, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 46

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Regular CPT

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

Massed CPT

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 and Locations

Central contacts

Research Associate I

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

Locations

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

Recruiting

Austin, Texas, United States, 78701

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • PTSD
  • pregnancy
  • cognitive processing therapy
  • psychotherapy
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-16.