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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD115845 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
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| Usual Care Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrative Exposure Therapy (NET) | Behavioral | Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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). | Post-intervention time period (12 weeks post-baseline) for the NET treatment group |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | *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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Stress Scale (PSS) | Exploratory self-report measure that assesses participants' feelings about their parenting role | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) |
| Treatment Tracking |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle L. Miller, PhD | Contact | 317-963-7257 | mlm41@iu.edu | |
| Neva Brown, BA | Contact | mlm41@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle L. Miller, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40395722 | Background | 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. | |
| 33298159 | Background | 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. |
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We will share the study protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF)
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.
The study team currently has access to all documents and the Study Protocol and SAP are available through the OSF preregistration website.
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Potential participants will be screened to determine eligibility. If interested and eligible, informed consent will be obtained prior to beginning the study. After signing consent, participants will be asked to complete a self-report baseline assessment. After collection of baseline data, participants will be randomized 1:1 to the NET intervention or usual care group. Block randomization will be used with computer-generated randomization lists provided by the study statistician. All participants will be asked to complete self-report assessments at standard intervention assessment time points: Time 1 (0 weeks; baseline) Time 2 (12 weeks; post-intervention) and Time 3 (24 weeks; 3-month follow-up). Qualitative feedback will be gathered at Time 3, after other data collection is complete. Recruitment procedures, eligibility determination, and assessments will be identical for both groups. Study participation will last 24 weeks, starting at Time 1 (Week 0).
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Study statistician
| Edinburgh Postnatal Depression Scale (EPDS) |
Self-report assessment of depressive symptoms in the perinatal period, including suicidality. |
| *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 |
| 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. | 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. | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) |
A brief study-specific measure to assess changes to medication doses and/or psychotherapy
| *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 |
| Perinatal Life Events Checklist | Exploratory study specific self-report measure used to assess potentially traumatic events that occur during pregnancy and the postpartum period. | Baseline and follow-up (24 weeks post-baseline) |
| Posttraumatic Growth Inventory (PGI) | A self-report measure assessing to assess post-trauma growth and self-improvement a person undergoes. | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) |
| 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. | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) |
| Social Isolation | The UCLA 3-item Social Isolation scale will be used to assess loneliness and social isolation, a predictor of maternal health. | Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline) |
| 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. | *Week 4 of intervention period *Post-intervention time period (12 weeks post-baseline) for the NET treatment group |