The New Empowerment After eXposure to Trauma (NEXT) Study

Browse trials for

• Combat Disorders 200
• Stress Disorders, Post-Traumatic 2,682

Keywords

• Pregnancy
• Postpartum Period
• Narrative Exposure Therapy
• Post-Traumatic Stress Disorder
• Brief interventions

Combat Disorders

200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.

This study's planned enrollment of 106 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Study arms

• Experimental
  Treatment Group

  Participants will complete a brief Narrative Exposure Therapy (NET) intervention. NET is a potent exposure-based intervention that is fully manualized, short-term, and developed for individuals with multiple traumas. NET is effective in as little as four sessions and can be completed virtually. NET involves four parts: 1) psychoeducation on trauma exposure and PTSD, 2) laying the Lifeline (constructing a life events inventory, including meaningful events and trauma exposures), 3) exposure sessions (retelling of a traumatic event while constructing the trauma narrative in the context of the life course), and 4) reading of the full written narrative, written by the study therapist after each exposure.

  Behavioral: Narrative Exposure Therapy (NET)

• No intervention
  Usual Care Group

  This group will receive usual care for physical and mental health concerns during pregnancy and the postpartum period. Participation in the usual care group will consist of symptom monitoring (study staff) and participant's primary care/obstetric care for all other concerns. After enrollment in the study, the research assistant will have a structured 10-15 call/visit with usual care group participants to assess existing psychosocial support/health providers and provide a list of mental health services across IUSM and the state of Indiana/perinatal supports. They will encourage participants to follow-up with their primary care/obstetric care provider/community organizations for more help if needed. All usual care group participants will be offered the NET intervention after study assessments have been collected.

Interventions

• BehavioralNarrative Exposure Therapy (NET)

  Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.

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 group

Secondary 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 period

2. 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

3. 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 period

3. 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)

5. Centrality of Event (CE)

   This 7-item measure assesses how central a traumatic event is to a participant's identity and life story and if that changes with intervention.

   Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

6. Social Isolation

   The UCLA 3-item Social Isolation scale will be used to assess loneliness and social isolation, a predictor of maternal health.

   Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)

7. Therapist Alliance

   The Working Alliance Inventory-Short-Form (WAI-SF) will be used to assess how participant feels about fit with study therapist assigned to them at mid- and end of treatment.

   Time frame: *Week 4 of intervention period *Post-intervention time period (12 weeks post-baseline) for the NET treatment group

Publications

• Miller ML, Wasson RS, Jiang LJ, Ward MJ, Meyer DJ, Haas DM. Narrative Exposure Therapy: Expanding Virtual Treatment of Posttraumatic Stress Disorder to the Postpartum Period. J Aggress Maltreat Trauma. 2025;34(4):538-557. doi: 10.1080/10926771.2025.2491772. Epub 2025 Apr 20. PubMed 40395722 ↗
• Stevens NR, Miller ML, Soibatian C, Otwell C, Rufa AK, Meyer DJ, Shalowitz MU. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET). BMC Psychol. 2020 Dec 9;8(1):130. doi: 10.1186/s40359-020-00503-4. PubMed 33298159 ↗

Individual participant data

Plan to share: Yes — We will share the study protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF)

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The Study Protocol and SAP will be pre-registered and available at the start of the trial (9/15/25). The Informed Consent form will be approved by the Institution IRB prior to the start of the trial and available by request. There is not a specified end date for these materials.

Access criteria: The study team currently has access to all documents and the Study Protocol and SAP are available through the OSF preregistration website.