The New Empowerment After eXposure to Trauma (NEXT) Study
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• 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)
Locations
United States
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Contact Information
Primary
Michelle L. Miller, PhD
mlm41@iu.edu
317-963-7257
Backup
Neva Brown, BA
mlm41@iu.edu
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 106
Treatments
Experimental: Treatment Group
Participants will complete a brief Narrative Exposure Therapy (NET) intervention. NET is a potent exposure-based intervention that is fully manualized, short-term, and developed for individuals with multiple traumas. NET is effective in as little as four sessions and can be completed virtually. NET involves four parts: 1) psychoeducation on trauma exposure and PTSD, 2) laying the Lifeline (constructing a life events inventory, including meaningful events and trauma exposures), 3) exposure sessions (retelling of a traumatic event while constructing the trauma narrative in the context of the life course), and 4) reading of the full written narrative, written by the study therapist after each exposure.
No_intervention: Usual Care Group
This group will receive usual care for physical and mental health concerns during pregnancy and the postpartum period. Participation in the usual care group will consist of symptom monitoring (study staff) and participant's primary care/obstetric care for all other concerns. After enrollment in the study, the research assistant will have a structured 10-15 call/visit with usual care group participants to assess existing psychosocial support/health providers and provide a list of mental health services across IUSM and the state of Indiana/perinatal supports. They will encourage participants to follow-up with their primary care/obstetric care provider/community organizations for more help if needed. All usual care group participants will be offered the NET intervention after study assessments have been collected.
Related Therapeutic Areas
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Indiana University