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The NEXT Study for Perinatal PTSD

The NEXT Study is looking at a new way to help women who have Post-Traumatic Stress Disorder (PTSD) related to childbirth. This study will test Narrative Exposure Therapy (NET), a type of behavioral therapy, to see if it's a good and practical treatment for pregnant or new mothers with PTSD. You might be able to join if you are a woman between 18 and 50 years old, can read and speak English, and have probable PTSD. The study wants to enroll 106 participants and compare NET to usual care. We will look at how easy the treatment is to use and how well people accept it over 24 weeks.

Study design
This is a randomized controlled pilot study, meaning participants will be randomly assigned to receive either Narrative Exposure Therapy (NET) or usual care. The study aims to enroll 106 participants.
What's involved
The study will track your progress at the beginning, 12 weeks after the intervention, and again at 24 weeks after the beginning of the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after the start of the study.

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NCT07175025

The New Empowerment After eXposure to Trauma (NEXT) Study

Recruiting
NAAges 18–50InterventionalTreatment
Indiana University
~106 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Narrative Exposure Therapy (NET)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility Tracking
Measured over Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
+2 more outcomes measured

Conditions

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

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Michelle L. Miller, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Michelle L. Miller, PhD
[email protected]
317-963-7257
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Feasibility TrackingBaseline, 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).

  • AcceptabilityPost-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

  • Perinatal NET Protocol Acceptability Questionnaire (PNPAQ)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).