Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients

The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:

Does PE+ decrease PTSD symptoms?

All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.

Participants will:

• Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
• Receive financial incentives for attending each PE+ session.
• Attend assessment visits every 4 weeks for the 12 weeks of the trial.
• Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged exposure therapy + incentives for therapy session attendance

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Peck, PhD; Phone Number: 802-656-9610; Email: kelly.peck@uvm.edu

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont
      • Contact: Kelly Peck; Phone Number: 8026569610; Email: kelly.peck@uvm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female
• >18 years old
• Gestational age ≤ 25 weeks
• Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
• Participants receiving psychotropic medications must be maintained on a stable dose for >14 days prior to enrollment.

Exclusion Criteria:

• Male
• Under 18 years old
• Gestational age > 25 weeks
• No current diagnosis of PTSD
• Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
• Enrolled in another ongoing evidence-based treatment for PTSD.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged exposure therapy + incentives for therapy session attendance	Behavioral: Prolonged exposure therapy + incentives for therapy session attendance; Prolonged exposure therapy plus incentives for therapy session attendance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated	Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).	From baseline to the 12-week assessment
Acceptability of prolonged exposure therapy + incentives for therapy session attendance	Change in treatment acceptability as measured by the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item scale, each with a range of 1-7 and some of which are reverse-scored. The total TAAS score is calculated by summing the score for the 10 TAAS items and the overall TAAS score ranges from 10-70, with higher scores representing better outcomes (greater treatment acceptability).	From baseline to the 12-week assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in posttraumatic stress disorder symptom severity - self-reported	Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).	From baseline to the 12-week assessment
Mean change in subjective units of distress	The mean change in subjective units of distress scale (SUDS) ratings from before each imaginal exposure exercise to the peak (highest) level of distress reported during the exercise measured with a single item (range: 0-100).	Within 1-hour
Change in self-reported posttraumatic stress disorder symptom severity between PE sessions	The percentage of participants who have a reliable exacerbation in PTSD symptoms between sessions	In the 1 week
Prolonged exposure therapy discontinuation	The percentage of participants who complete <8 prolonged exposure therapy sessions	From baseline to the 12-week assessment
Neonatal birth weight	Neonatal birth weight in grams	Delivery
Gestational age at delivery	Gestational age at delivery in weeks	Delivery
Maternal delivery complications	The percentage of participants who experience delivery complications (i.e., abruption/bleeding, hypertensive disorders, and preterm premature rupture of membranes or preterm labor)	Delivery
Mean percent change in heart rate	The mean percent change in heart rate from before each imaginal exposure exercise to peak (highest) heart rate during the exercise	Within 1-hour

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 22, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: UVM CHRMS STUDY00002930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No