The New Empowerment After eXposure to Trauma (NEXT) Study

Not Applicable

Not yet recruiting

• Conditions: PTSD - Post Traumatic Stress Disorder; PTSD (Childbirth-Related)

• Registration Number: NCT07175025
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study Start: 2025-09-15
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2027-12
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 106

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
• current psychotic or manic symptoms
• cognitive impairment
• concurrent trauma-focused psychotherapy
• unstable dose of psychiatric medications (must be stable for 6 weeks)
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility Tracking	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).
Acceptability	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
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).

Secondary Outcome Measures

Name	Time	Method
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	Self-report assessment of PTSD symptoms in response to a traumatic event in past week or past month
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	Self-report assessment of depressive symptoms in the perinatal period, including suicidality.
Life Events Checklist (LEC)	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.
Perinatal Quality of Life	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.

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States