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)
Conditions
PTSD - Post Traumatic Stress DisorderPTSD (Childbirth-Related)
Locations
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States