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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder (PTSD) Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regular CPT

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

Group Type EXPERIMENTAL

Regular CPT

Intervention Type BEHAVIORAL

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

mCPT

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

Group Type EXPERIMENTAL

Massed CPT

Intervention Type BEHAVIORAL

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

Interventions

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Regular CPT

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

Intervention Type BEHAVIORAL

Massed CPT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No