Status:
RECRUITING
The New Empowerment After eXposure to Trauma (NEXT) Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
PTSD - Post Traumatic Stress Disorder
PTSD (Childbirth-Related)
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT07175025
Start Date
September 15 2025
End Date
July 31 2028
Last Update
November 19 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202