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NCT07175025NARecruiting

The New Empowerment After eXposure to Trauma (NEXT) Study

Indiana University

Start Date

9/24/2025

Completion Date

7/31/2028

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.

Eligibility Criteria

Age Range: 18 years to 50 years

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

Interventions

BEHAVIORAL

Narrative Exposure Therapy (NET)

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Conditions

PTSD - Post Traumatic Stress DisorderPTSD (Childbirth-Related)

Locations

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States