NCT07175025 · Indiana University
The New Empowerment After eXposure to Trauma (NEXT) Study
(NEXT)
What this study is about
The NEXT Study is a randomly assigned 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 randomly assigned to usual care (n=45; comparator group).
View original scientific description
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)
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
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
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Indianapolis, Indiana
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations