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The New Empowerment After eXposure to Trauma (NEXT) Study | Clinical Trials | Clareo Health

RECRUITINGNA

The New Empowerment After eXposure to Trauma (NEXT) Study

NCT07175025•Indiana University

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.

Eligibility

Age

18 - 50 years

Sex

FEMALE

Healthy Volunteers

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)

Exclusion Criteria

•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

Locations (1)

Indiana University School of Medicine

Indianapolis, Indiana, United States

Key Dates

Start Date

September 15, 2025

Primary Completion Date

December 1, 2027

Completion Date

July 31, 2028

Last Updated

November 19, 2025

Enrollment

106

ESTIMATED participants

Conditions

PTSD - Post Traumatic Stress DisorderPTSD (Childbirth-Related)

Interventions

Narrative Exposure Therapy (NET)

BEHAVIORAL

Contacts

Michelle L. Miller, PhD

CONTACT

317-963-7257 mlm41@iu.edu

Neva Brown, BA

CONTACT

mlm41@iu.edu

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

NCT07462312

PTSD - Post Traumatic Stress Disorder

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RECRUITING

Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany

NCT07368166

PTSD - Post Traumatic Stress DisorderPTSD-Related Functional Impairment in Children and Adolescents

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The New Empowerment After eXposure to Trauma (NEXT) Study

Inclusion Criteria

Exclusion Criteria

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany

Transcranial Magnetic Stimulation in Veterans With PTSD

Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects

Restorative Early Sleep Treatment After the Emergency Department