Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prolonged exposure therapy + incentives for therapy session attendance.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder, Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Prolonged exposure therapy + incentives for therapy session attendance
Prolonged exposure therapy plus incentives for therapy session attendance
Primary outcome measures
- Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated [Time frame: From baseline to the 12-week assessment]
- Acceptability of prolonged exposure therapy + incentives for therapy session attendance [Time frame: From baseline to the 12-week assessment]
Secondary outcome measures (8)
- Change in posttraumatic stress disorder symptom severity - self-reported [Time frame: From baseline to the 12-week assessment]
- Mean change in subjective units of distress [Time frame: Within 1-hour]
- Mean percent change in heart rate [Time frame: Within 1-hour]
- Change in self-reported posttraumatic stress disorder symptom severity between PE sessions [Time frame: In the 1 week]
- Prolonged exposure therapy discontinuation [Time frame: From baseline to the 12-week assessment]
- Neonatal birth weight [Time frame: Delivery]
- Gestational age at delivery [Time frame: Delivery]
- Maternal delivery complications [Time frame: Delivery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Vermont — Burlington
Identifiers
NCT: NCT06670079 · UVM CHRMS STUDY00002930