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

The University of Texas System (UT)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder (PTSD); Pregnancy

Treatments: Behavioral: Regular CPT; Behavioral: Massed CPT

Study type: Interventional

Funder types: Other

Identifiers

NCT07060144

00006641

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Regular CPT

Experimental group

Description:

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

Treatment:

Behavioral: Regular CPT

mCPT

Experimental group

Description:

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

Treatment:

Behavioral: Massed CPT