Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 46 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Texas at Austin

Study Contact

Research Associate I
512-766-6209
ambreen.rana@austin.utexas.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.