New Empowerment After Exposure to Trauma (NEXT) perinatal PTSD program
Official title: The New Empowerment After eXposure to Trauma (NEXT) Study
Run by Indiana University · NCT07175025 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 106 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | July 31, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07175025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 12 weeks) at the time of the eligibility screen Exclusion criteria * current severe suicide risk as determined by the Columbia Suicide Severity Rating Scale Screener (C-SSRS) * current psychotic or manic symptoms as determined by the DIAMOND screener and the Mood Disorder Questionnaire for Bipolar Disorder * 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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
COMP360 psilocybin for PTSD: see if it helps reduce symptoms with guided support
This study tests COMP360 (a lab-made psilocybin) to see if it can help reduce PTSD symptoms in adults, with supervision from a trained team.
-
Virtual Reality–Assisted Trauma-Focused CBT for PTSD
A VR-assisted trauma-focused CBT approach is being tested to see if it helps adults with PTSD related to Northern Ireland–specific trauma.
-
ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury
This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Predicting nightmare awakenings in PTSD using an AI algorithm
The study tests an AI tool called CAUD-PIN to see if it can reliably predict when trauma-related nightmares will wake military personnel or veterans with PTSD.
-
Dexmedetomidine with taVNS to see if PTSD after trauma surgery can be reduced
This study tests whether giving dexmedetomidine together with transcutaneous vagus nerve stimulation after emergency trauma surgery can lower the chances of developing PTSD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.