New Empowerment After Exposure to Trauma (NEXT) perinatal PTSD program
The New Empowerment After eXposure to Trauma (NEXT) Study
This project tries a short virtual Narrative Exposure Therapy program to see if it helps pregnant and recently postpartum people with PTSD compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07175025 on ClinicalTrials.gov |
What this trial studies
This randomized pilot enrolls perinatal participants who screen positive for probable PTSD on the PCL-5 and randomizes them to brief virtual Narrative Exposure Therapy (NET) or usual care, with roughly 45 people per arm. The protocol tests a revised, brief perinatal NET delivered remotely to pregnant or postpartum people (delivered within the protocol's postpartum window) and focuses on feasibility and acceptability. Key exclusions include current severe suicide risk, active psychosis or mania, cognitive impairment, ongoing trauma-focused psychotherapy, legal proceedings related to the trauma, or medical contraindications to exposure-based work. Outcomes will center on feasibility metrics, participant-reported acceptability, and preliminary changes in PTSD symptoms to inform a larger definitive trial.
Who should consider this trial
Good fit: Pregnant people or those within the protocol's early postpartum window, age 18 or older, who can read and speak English and screen positive for probable PTSD on the PCL-5 are the ideal candidates.
Not a fit: People who do not meet PTSD criteria, are outside the trial's postpartum timing window, or who have contraindications such as current severe suicide risk, active psychosis or mania, cognitive impairment, concurrent trauma-focused therapy, legal actions related to their trauma, or medical reasons limiting exposure therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, a brief virtual NET program could reduce PTSD symptoms and expand access to trauma-focused care during pregnancy and the early postpartum period.
How similar studies have performed: Narrative Exposure Therapy has shown benefit for PTSD in other populations such as refugees and complex trauma groups, but brief virtual delivery specifically for perinatal PTSD remains relatively untested and this pilot aims to fill that gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * able to read and speak English * diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5) * pregnant or postpartum (delivered within 16 weeks) at the time of the eligibility screen Exclusion criteria * current severe suicide risk * current psychotic or manic symptoms * cognitive impairment * concurrent trauma-focused psychotherapy * medical advice limiting participation in exposure therapy * current legal actions related to trauma * does not meet criteria for PTSD * not pregnant or delivered more than 12 weeks after timing of eligibility screening
Where this trial is running
Indianapolis, Indiana
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Michelle L. Miller, PhD — Indiana University
- Study coordinator: Michelle L. Miller, PhD
- Email: mlm41@iu.edu
- Phone: 317-963-7257
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.