Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients

NCT ID: NCT06670079

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-04-30

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolonged exposure therapy + incentives for therapy session attendance

Group Type: EXPERIMENTAL

Prolonged exposure therapy + incentives for therapy session attendance

Intervention Type: BEHAVIORAL

Prolonged exposure therapy plus incentives for therapy session attendance

Interventions

Prolonged exposure therapy + incentives for therapy session attendance

Prolonged exposure therapy plus incentives for therapy session attendance

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Kelly Peck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont

Burlington, Vermont, United States

Countries

United States

Central Contacts

Kelly Peck, PhD

Role: CONTACT

kelly.peck@uvm.edu

802-656-9610

Facility Contacts

Kelly Peck

Role: primary

kelly.peck@uvm.edu

8026569610

Other Identifiers

UVM CHRMS STUDY00002930

Identifier Type: -

Identifier Source: org_study_id