Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients

NCT06670079 | Recruiting

• 1 other identifier: UVM CHRMS STUDY00002930
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in posttraumatic stress disorder symptom severity - self-reported

  From baseline to the 12-week assessment

• Mean change in subjective units of distress

  Within 1-hour

• Mean percent change in heart rate

  Within 1-hour

• Change in self-reported posttraumatic stress disorder symptom severity between PE sessions

  In the 1 week

• Prolonged exposure therapy discontinuation

  From baseline to the 12-week assessment

Study Arms (1)

Prolonged exposure therapy + incentives for therapy session attendance

EXPERIMENTAL

Behavioral: Prolonged exposure therapy + incentives for therapy session attendance

Interventions

Prolonged exposure therapy + incentives for therapy session attendance BEHAVIORAL

Prolonged exposure therapy plus incentives for therapy session attendance

Prolonged exposure therapy + incentives for therapy session attendance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Kelly Peck, PhD

CONTACT

802-656-9610; kelly.peck@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)