The New Empowerment After eXposure to Trauma (NEXT) Study
NCT ID: NCT07175025
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
106 participants
INTERVENTIONAL
2025-09-15
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Narrative Exposure Therapy (NET)
Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
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.
No interventions assigned to this group
Interventions
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Narrative Exposure Therapy (NET)
Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
Eligibility Criteria
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Inclusion Criteria
* able to read and speak English
* diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Indiana University
OTHER
Responsible Party
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Michelle L. Miller
Assistant Professor
Principal Investigators
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Michelle L. Miller, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kays MB, Wack MF, Smith DW, Denys GA. Azithromycin treatment failure in community-acquired pneumonia caused by Streptococcus pneumoniae resistant to macrolides by a 23S rRNA mutation. Diagn Microbiol Infect Dis. 2002 Jun;43(2):163-5. doi: 10.1016/s0732-8893(02)00379-6.
Stevens NR, Miller ML, Soibatian C, Otwell C, Rufa AK, Meyer DJ, Shalowitz MU. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET). BMC Psychol. 2020 Dec 9;8(1):130. doi: 10.1186/s40359-020-00503-4.
Other Identifiers
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