Prolonged exposure therapy with attendance incentives for pregnant people with PTSD
Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
This program will try prolonged exposure therapy plus small financial incentives to help pregnant people reduce PTSD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Vermont Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT06670079 on ClinicalTrials.gov |
What this trial studies
This single-arm intervention provides weekly individual prolonged exposure therapy sessions for one hour over 12 weeks combined with financial incentives to encourage attendance. Participants complete assessment visits every four weeks during the 12-week period, and researchers will collect delivery information from medical records after birth. All enrolled participants who meet DSM-5 criteria for PTSD and are ≤25 weeks gestation receive the same PE+ intervention rather than being randomized. People on psychotropic medications must be on a stable dose for at least 14 days prior to enrollment, and individuals with active psychosis, unstable bipolar disorder, imminent suicide risk, or currently receiving another evidence-based PTSD treatment are excluded.
Who should consider this trial
Good fit: Pregnant people over 18 years old who are ≤25 weeks gestation and meet DSM-5 criteria for PTSD, and who are not in other evidence-based PTSD treatment, are ideal candidates.
Not a fit: People with active psychosis, unstable bipolar disorder, imminent suicide risk, those past 25 weeks gestation, without a current PTSD diagnosis, or already enrolled in another evidence-based PTSD treatment are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, PE+ could reduce PTSD symptoms during pregnancy, improving maternal mental health and possibly pregnancy and birth outcomes.
How similar studies have performed: Prolonged exposure is an established, effective PTSD therapy in nonpregnant adults and incentives have improved treatment attendance, but combining PE with incentives specifically in pregnant patients is not well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Burlington, Vermont
- University of Vermont — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Kelly Peck, PhD
- Email: kelly.peck@uvm.edu
- Phone: 802-656-9610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.