Posttraumatic Stress Disorder (PTSD)NCT07060144
Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
A study testing Regular CPT and Massed CPT in people with Posttraumatic Stress Disorder (PTSD) and Pregnancy, run by University of Texas at Austin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Pregnancy
- What is being tested?
- Regular CPT and Massed CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (> 4x weekly)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin, Dell Medical School, Department of Psychiatry
Austin, Texas, 78701
About this study
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
- Being tested
- Regular CPT, Massed CPT
- Keywords
- PTSD, pregnancy, cognitive processing therapy, psychotherapy, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular CPTBehavioural
Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total
Massed CPTBehavioural
Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total)
| Study group | Role | What they receive |
|---|---|---|
| Regular CPT | Experimental | Standard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total Receives: Behavioral: Regular CPT |
| mCPT | Experimental | Massed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total) Receives: Behavioral: Massed CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure. Higher scores reflect greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity. PCL-5 Monthly will be collected at Visit 1, and the PCL-5 weekly will be collected at 1 week, 4 weeks, 8 weeks, 12 weeks, and 16 weeks following initiation of treatment in both groups.
Measured: 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 outcomes (4)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is used for screening, diagnosing, monitoring, and measuring the severity of depression. Nine questions each scored from 0 (Not at all) to 3 (Nearly every day). Total score ranging from 0 to 27, with higher scores indicating more severe depression: 1 - 4: Minimal or no depression, 5 - 9: Mild depression, 10 - 14: Moderate depression, 15 - 19: Moderately severe depression, and 20 - 27: Severe depression
Measured: 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)
The Prenatal Attachment Inventory (PAI) is a 21-item questionnaire designed to assess a pregnant woman's thoughts, feelings, and experiences related to her unborn child and her level of attachment to the fetus. It uses a 4-point Likert scale for each item (4 = almost always; 3 = often; 2 = sometimes, 1 = almost never), with scores ranging from 21 to 84, where higher scores indicate a stronger prenatal attachment.
Measured: Baseline
Maternal Attachment Inventory (MAI)
The Maternal Attachment Inventory (MAI) is a 26-item, self-report questionnaire used to assess the emotional bond between a mother and her infant. It measures maternal feelings and behaviors that reflect affection and love for the baby. Higher scores on the MAI indicate a stronger maternal attachment. The scale utilizes a four-point Likert scale for responses (4 = almost always; 3 = often; 2 = sometimes, 1 = almost never), and the total score ranges from 26 to 104.
Measured: Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)
Infant CARE-Index (CARE-Index)
The Infant CARE-Index assesses parent-infant interaction. It is a videotaped 3-5 minute free-play observation in which the adult is asked 'to play with your child as you usually would'. Gives an assessment of the best of their potential interaction at times of low stress, i.e ideal functioning, but the scores are highly correlated with attachment. The Infant CARE-Index (ICI) is unique because it can be used from birth to 15 months and in multiple locations. The videotapes are coded by reliable coders who are blind to all information about the dyad. Based on directions in the manual, the ICI yields: Adult scores on sensitivity, control, and unresponsiveness; Infant scores on cooperation, compulsivity, difficultness, and passivity. A dyadic synchrony indicative of the degree of risk to the child's future development.
Measured: Once within 1-90 days following participant's delivery (i.e once within 3 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Richardson, University of Texas at Austin
- Investigators
- Erin Richardson, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060144
- Sponsor's protocol ID
- 00006641
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07060144
- Acronym / sponsor ID
- 00006641
- Conditions
- Posttraumatic Stress Disorder (PTSD), Pregnancy
- Keywords
- PTSD, pregnancy, cognitive processing therapy, psychotherapy, trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular CPT | Experimental | Behavioral: Regular CPTStandard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total |
| mCPT | Experimental | Behavioral: Massed CPTMassed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total) |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (> 4x weekly)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular CPTStandard-model Cognitive Processing Therapy (CPT) - one 60-min session per week for 12 weeks total | Behavioural | Regular CPT |
| Massed CPTMassed CPT - two 60-min sessions each day for 5 consecutive days (10 sessions total) | Behavioural | mCPT |
Primary outcome
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
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure. Higher scores reflect greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity. PCL-5 Monthly will be collected at Visit 1, and the PCL-5 weekly will be collected at 1 week, 4 weeks, 8 weeks, 12 weeks, and 16 weeks following initiation of treatment in both groups.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Richardson principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular CPT and Massed CPT in people with Posttraumatic Stress Disorder (PTSD) and Pregnancy, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Associate I (512-766-6209, ambreen.rana@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.