The New Empowerment After eXposure to Trauma (NEXT) Study

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07175025
Status
Recruiting
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Conditions

  • PTSD (Childbirth-Related)
  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Narrative Exposure Therapy (NET) — BEHAVIORAL
    Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Feasibility Tracking [ Time Frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202
Michelle L. Miller, PhD
[email protected]
3179637257
Neva Brown, BA
[email protected]

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By research site
Indiana University School of Medicine· Indianapolis, IN

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