Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regular CPT, Massed CPT.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder (PTSD), Pregnancy. Basic parameters: 18 years — 46 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Regular CPT
Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total - Behavioral Massed CPT
Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Patient Health Questionnaire (PHQ-9) [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]
- Prenatal Attachment Inventory (PAI) [Time frame: Baseline]
- Maternal Attachment Inventory (MAI) [Time frame: Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)]
- Infant CARE-Index (CARE-Index) [Time frame: Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas at Austin, Dell Medical School, Department of Psychiatry — Austin
Identifiers
NCT: NCT07060144 · 00006641