Recruiting

NET

Sponsor:

Indiana University

Code:

NCT07175025

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD (Childbirth-Related)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Narrative Exposure Therapy (NET)

Study Details

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 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.

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD (Childbirth-Related)

Study ID

NCT07175025

Start date

Sep 24, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 12 weeks) at the time of the eligibility screen Exclusion criteria
  • 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
  • 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

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Narrative Exposure Therapy (NET)

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

Primary outcome measure

  • Feasibility Tracking [ Time Frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) ]
  • Acceptability [ Time Frame: Post-intervention time period (12 weeks post-baseline) ]
  • Perinatal NET Protocol Acceptability Questionnaire (PNPAQ) [ Time Frame: Post-intervention time period (12 weeks post-baseline) for the NET treatment group ]

Central Contacts and Locations

Central contacts

Michelle L. Miller, PhD

317-963-7257mlm41@iu.edu

Neva Brown, BA

mlm41@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Michelle L. Miller, PhD

3179637257mlm41@iu.edu

Neva Brown, BA

nevabrow@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Pregnancy
  • Postpartum Period
  • Narrative Exposure Therapy
  • Post-Traumatic Stress Disorder
  • Brief interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-18.