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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
Indiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGFeasibility Tracking
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).
Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
Acceptability
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
Time frame: Post-intervention time period (12 weeks post-baseline)
Perinatal NET Protocol Acceptability Questionnaire (PNPAQ)
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).
Time frame: Post-intervention time period (12 weeks post-baseline) for the NET treatment group
PTSD Checklist for DSM-5 (PCL-5)
Self-report assessment of PTSD symptoms in response to a traumatic event in past week or past month
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)
Self-report assessment of depressive symptoms in the perinatal period, including suicidality.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Life Events Checklist (LEC)
Used to self-report traumatic events over the lifetime at start of study as well as any new traumas experienced during treatment period.
Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
Perinatal Quality of Life
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.
Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)