The New Empowerment After eXposure to Trauma (NEXT) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorIndiana University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Narrative Exposure Therapy (NET)
BehavioralNarrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility 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)2
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)3
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 groupSecondary outcomes
1
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 period2
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 period3
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)4
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)Other outcomes
1
Parental Stress Scale (PSS)
Exploratory self-report measure that assesses participants' feelings about their parenting role
Time frame
Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)2
Treatment Tracking
A brief study-specific measure to assess changes to medication doses and/or psychotherapy
Time frame
*Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) *Weekly to biweekly across 12 week intervention time period3
Perinatal Life Events Checklist
Exploratory study specific self-report measure used to assess potentially traumatic events that occur during pregnancy and the postpartum period.
Time frame
Baseline and follow-up (24 weeks post-baseline)4
Posttraumatic Growth Inventory (PGI)
A self-report measure assessing to assess post-trauma growth and self-improvement a person undergoes.
Time frame
Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov