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Recruiting NCT07175025

The New Empowerment After eXposure to Trauma (NEXT) Study

No phase Interventional PTSD - Post Traumatic Stress Disorder PTSD (Childbirth-Related)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Narrative Exposure Therapy (NET).
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder, PTSD (Childbirth-Related). Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • 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]
  • Life Events Checklist (LEC) [Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)]
  • Perinatal Quality of Life [Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Indiana University School of Medicine — Indianapolis

Publications

  • Miller ML, Wasson RS, Jiang LJ, Ward MJ, Meyer DJ, Haas DM. Narrative Exposure Therapy: Expanding Virtual Treatment of Posttraumatic Stress Disorder to the Postpartum Period. J Aggress Maltreat Trauma. 2025;34(4):538-557. doi: 10.1080/10926771.2025.2491772. Epub 2025 Apr 20. PMID 40395722
  • 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

Identifiers

NCT: NCT07175025 · K23HD115845 · K23HD115845

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗