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NCT Number: NCT07175025

The New Empowerment After eXposure to Trauma (NEXT) Study

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.

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Combat Disorders Mental Disorders PTSD (Childbirth-Related) Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Michelle L. Miller, PhD

CONTACT

[email protected]

3179637257

Neva Brown, BA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Exposure Therapy (NET)

Behavioral

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

Primary outcomes

  1. Feasibility Tracking

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

    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).

  2. Acceptability

    Time frame: Post-intervention time period (12 weeks post-baseline)

    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

  3. Perinatal NET Protocol Acceptability Questionnaire (PNPAQ)

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

    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).

Secondary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: *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

    Self-report assessment of PTSD symptoms in response to a traumatic event in past week or past month

  2. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: *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

    Self-report assessment of depressive symptoms in the perinatal period, including suicidality.

  3. Life Events Checklist (LEC)

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

    Used to self-report traumatic events over the lifetime at start of study as well as any new traumas experienced during treatment period.

  4. Perinatal Quality of Life

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

    Mother-Generated Index (MGI) will be used to assess valued life domains by specifying up to eight areas of their lives which have been affected by being pregnant/ giving birth to a baby, assessing how the participant felt about this area over the previous month, and describing the domains most important to her.

Other outcomes

  1. Parental Stress Scale (PSS)

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

    Exploratory self-report measure that assesses participants' feelings about their parenting role

  2. Treatment Tracking

    Time frame: *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

    A brief study-specific measure to assess changes to medication doses and/or psychotherapy

  3. Perinatal Life Events Checklist

    Time frame: Baseline and follow-up (24 weeks post-baseline)

    Exploratory study specific self-report measure used to assess potentially traumatic events that occur during pregnancy and the postpartum period.

  4. Posttraumatic Growth Inventory (PGI)

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

    A self-report measure assessing to assess post-trauma growth and self-improvement a person undergoes.

  5. Centrality of Event (CE)

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

    This 7-item measure assesses how central a traumatic event is to a participant's identity and life story and if that changes with intervention.

  6. Social Isolation

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

    The UCLA 3-item Social Isolation scale will be used to assess loneliness and social isolation, a predictor of maternal health.

  7. Therapist Alliance

    Time frame: *Week 4 of intervention period *Post-intervention time period (12 weeks post-baseline) for the NET treatment group

    The Working Alliance Inventory-Short-Form (WAI-SF) will be used to assess how participant feels about fit with study therapist assigned to them at mid- and end of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle L. Miller, PhD

CONTACT

[email protected]

317-963-7257

Neva Brown, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: NEXT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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