RecruitingNot Applicable

The New Empowerment After eXposure to Trauma (NEXT) Study

United States106 participantsStarted 2025-09-24

Plain-language summary

The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is specifically focused on childbirth-related PTSD — can you help me figure out whether my experience and symptoms match what this trial is designed to study?
2Since this trial is in an early feasibility phase rather than a later treatment-effectiveness phase, what does that mean for what we'd actually learn about whether the therapy works, versus just whether it's practical to run?
3The study is measuring something called the Perinatal NET Protocol — can you explain what Narrative Exposure Therapy involves and how it differs from other trauma treatments I might be able to access right now?
4Given that this is still a feasibility study, would you recommend I consider this trial alongside or instead of standard PTSD treatments that already have more established evidence behind them?
5This trial is actively recruiting, so if we decide it's worth exploring, what would my actual time commitment look like during the perinatal period, and is the pace realistic given where I am postpartum or in my pregnancy?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility Tracking

Timeframe: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

Acceptability

Timeframe: Post-intervention time period (12 weeks post-baseline)

Perinatal NET Protocol Acceptability Questionnaire (PNPAQ)

Timeframe: Post-intervention time period (12 weeks post-baseline) for the NET treatment group

Trial details

NCT IDNCT07175025

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Michelle L. Miller, PhD

317-963-7257 mlm41@iu.edu

View on ClinicalTrials.gov More PTSD - Post Traumatic Stress Disorder trials