The New Empowerment After eXposure to Trauma (NEXT) Study

NCT07175025 | Recruiting DMC

• 1 other identifier: K23HD115845
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility Tracking

  The investigators will determine feasibility by enrollment (≥75% of potential participants enroll), treatment adherence (≥80% of treatment group complete 5/6 NET sessions), assessment completion/each time point (≥75% of sample), and study completion (≥75% of sample).

  Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

• Acceptability

  The Triple P-Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), \& Feasibility of Intervention Measure (FIM) scales will be used to assess overall acceptability of the NEXT protocol

  Post-intervention time period (12 weeks post-baseline)

• Perinatal NET Protocol Acceptability Questionnaire (PNPAQ)

  A 20-item study-specific measure used to assess various PNET protocol components as well as 10 exploratory questions on acceptability of potential future protocol elements (e.g., collection biomarkers, in person v. virtual).

  Post-intervention time period (12 weeks post-baseline) for the NET treatment group

Secondary Outcomes (4)

• PTSD Checklist for DSM-5 (PCL-5)

  *Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline). *Weekly to biweekly administration across 12 week intervention period

• Edinburgh Postnatal Depression Scale (EPDS)

  *Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline). *Weekly to biweekly administration across 12 week intervention period

• Life Events Checklist (LEC)

  Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

• Perinatal Quality of Life

  Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

Other Outcomes (10)

• Parental Stress Scale (PSS)

  Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

• Treatment Tracking

  *Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) *Weekly to biweekly across 12 week intervention time period

• Perinatal Life Events Checklist

  Baseline and follow-up (24 weeks post-baseline)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: Narrative Exposure Therapy (NET)

Usual Care Group

NO INTERVENTION

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) BEHAVIORAL

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• current severe suicide risk
• 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

Sponsors & Collaborators

• Indiana University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 12088625 BACKGROUND

• 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.

  PMID: 33298159 BACKGROUND

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michelle L. Miller, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle L. Miller, PhD

CONTACT

317-963-7257; mlm41@iu.edu

Neva Brown, BA

CONTACT

mlm41@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Potential participants will be screened to determine eligibility. If interested and eligible, informed consent will be obtained prior to beginning the study. After signing consent, participants will be asked to complete a self-report baseline assessment. After collection of baseline data, participants will be randomized 1:1 to the NET intervention or usual care group. Block randomization will be used with computer-generated randomization lists provided by the study statistician. All participants will be asked to complete self-report assessments at standard intervention assessment time points: Time 1 (0 weeks; baseline) Time 2 (12 weeks; post-intervention) and Time 3 (24 weeks; 3-month follow-up). Qualitative feedback will be gathered at Time 3, after other data collection is complete. Recruitment procedures, eligibility determination, and assessments will be identical for both groups. Study participation will last 24 weeks, starting at Time 1 (Week 0).

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The Study Protocol and SAP will be pre-registered and available at the start of the trial (9/15/25). The Informed Consent form will be approved by the Institution IRB prior to the start of the trial and available by request. There is not a specified end date for these materials.
• Access Criteria: The study team currently has access to all documents and the Study Protocol and SAP are available through the OSF preregistration website.

Locations

US (1)