PTSD - Post Traumatic Stress DisorderNEXTNCT07175025
The New Empowerment After eXposure to Trauma (NEXT) Study
A study testing Narrative Exposure Therapy (NET) in people with PTSD - Post Traumatic Stress Disorder and PTSD (Childbirth-Related), run by Indiana University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, PTSD (Childbirth-Related)
- What is being tested?
- Narrative Exposure Therapy (NET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neva Brown, BA contact
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Michelle L. Miller, PhD, 3179637257, mlm41@iu.edu
Neva Brown, BA, nevabrow@iu.edu
About this study
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.
- Being tested
- Narrative Exposure Therapy (NET)
- Keywords
- Pregnancy, Postpartum Period, Narrative Exposure Therapy, Post-Traumatic Stress Disorder, Brief interventions
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure Therapy (NET)Behavioural
Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Narrative Exposure Therapy (NET) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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).
Measured: Post-intervention time period (12 weeks post-baseline) for the NET treatment group
Secondary outcomes (4)
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
Measured: *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.
Measured: *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.
Measured: 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.
Measured: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start24 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michelle L. Miller, Indiana University
- Investigators
- Michelle L. Miller, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175025
- Sponsor's protocol ID
- K23HD115845
- Other IDs
- K23HD115845
- Acronym
- NEXT
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the study protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF)
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 40395722Stevens 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Empowerment After eXposure to Trauma (NEXT) Study
- ClinicalTrials.gov ID
- NCT07175025
- Acronym / sponsor ID
- NEXT / K23HD115845
- Keywords
- Pregnancy, Postpartum Period, Narrative Exposure Therapy, Post-Traumatic Stress Disorder, Brief interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Narrative Exposure Therapy (NET)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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure Therapy (NET)Narrative Exposure Therapy (NET) is the PTSD intervention for the treatment group. | Behavioural | Treatment Group |
Primary outcome
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).
4 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5)
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)
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
Life Events Checklist (LEC)
Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
Perinatal Quality of Life
Time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 40395722Miller 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.
- Background: PubMed 33298159Stevens 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.
- Individual participant dataSharing planned: Yes. We will share the study protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neva Brown, BA contact
Michelle L. Miller, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy (NET) in people with PTSD - Post Traumatic Stress Disorder and PTSD (Childbirth-Related), run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle L. Miller, PhD (317-963-7257, mlm41@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Tracking (time frame: Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.