The New Empowerment After eXposure to Trauma (NEXT) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorIndiana University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Narrative Exposure Therapy (NET)
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov