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NCT Number: NCT06670079

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Pregnancy Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Location status: Recruiting

Location contact

Kelly Peck

CONTACT

[email protected]

8026569610

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolonged exposure therapy + incentives for therapy session attendance

Behavioral

Prolonged exposure therapy plus incentives for therapy session attendance

Primary outcomes

  1. Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated

    Time frame: From baseline to the 12-week assessment

    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).

  2. Acceptability of prolonged exposure therapy + incentives for therapy session attendance

    Time frame: From baseline to the 12-week assessment

    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).

Secondary outcomes

  1. Change in posttraumatic stress disorder symptom severity - self-reported

    Time frame: From baseline to the 12-week assessment

    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).

  2. Mean change in subjective units of distress

    Time frame: Within 1-hour

    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).

  3. Mean percent change in heart rate

    Time frame: Within 1-hour

    The mean percent change in heart rate from before each imaginal exposure exercise to peak (highest) heart rate during the exercise

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

    Time frame: In the 1 week

    The percentage of participants who have a reliable exacerbation in PTSD symptoms between sessions

  5. Prolonged exposure therapy discontinuation

    Time frame: From baseline to the 12-week assessment

    The percentage of participants who complete <8 prolonged exposure therapy sessions

  6. Neonatal birth weight

    Time frame: Delivery

    Neonatal birth weight in grams

  7. Gestational age at delivery

    Time frame: Delivery

    Gestational age at delivery in weeks

  8. Maternal delivery complications

    Time frame: Delivery

    The percentage of participants who experience delivery complications (i.e., abruption/bleeding, hypertensive disorders, and preterm premature rupture of membranes or preterm labor)

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Peck, PhD

CONTACT

[email protected]

802-656-9610

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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