Narrative Exposure Therapy for Post-Traumatic Stress Disorder

(NEXT Trial)

Overseen By Neva Brown, BA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Severe suicide risk, Psychotic symptoms, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of Narrative Exposure Therapy (NET) for treating post-traumatic stress disorder (PTSD) in pregnant or postpartum women. NET involves discussing traumatic events in a structured manner and is designed to be quick and effective, even online. The trial will compare women receiving NET to those receiving usual care to determine which approach is more helpful. Suitable participants are those who are pregnant or have given birth in the last 16 weeks and exhibit symptoms of PTSD. As an unphased trial, this study provides a unique opportunity to enhance understanding of how NET can benefit pregnant or postpartum women with PTSD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for perinatal PTSD?

Research has shown that Narrative Exposure Therapy (NET) is generally safe for treating post-traumatic stress disorder (PTSD). Studies have found that NET effectively reduces PTSD symptoms, with many individuals completing the therapy without major issues.

For instance, one study found that NET helped reduce symptoms in people with PTSD without causing significant side effects. Another study demonstrated that NET was suitable and practical for different groups, such as homeless individuals with PTSD.

While NET is primarily used for trauma, it has not received FDA approval for other conditions. However, its use in many studies suggests it is generally well-tolerated. No major negative effects have been widely reported, which is reassuring for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Narrative Exposure Therapy (NET) is unique because it offers a structured, short-term approach specifically designed for individuals with multiple traumas, unlike many existing PTSD treatments that can be lengthy and less targeted. NET stands out by focusing on building a detailed life events inventory, which helps contextualize traumatic experiences within a person's life story, allowing for deeper understanding and processing. Researchers are excited about NET because it can be effectively delivered in just a few sessions, even virtually, making it more accessible and convenient for patients compared to traditional therapies.

What evidence suggests that Narrative Exposure Therapy is effective for PTSD?

Research has shown that Narrative Exposure Therapy (NET), which participants in this trial may receive, helps reduce symptoms of post-traumatic stress disorder (PTSD). In studies, people who received NET experienced fewer symptoms after treatment, and these improvements persisted over time. One review found that NET noticeably reduced PTSD symptoms both immediately after treatment and during follow-ups. Although some studies did not find significant changes, the overall evidence supports NET as an effective treatment for PTSD. This therapy involves discussing traumatic events in a structured manner to help manage and relieve symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Michelle L. Miller, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

The NEXT Study is for perinatal individuals who are experiencing PTSD. To participate, they must be in the perinatal period and have a diagnosis of PTSD. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Able to read and speak English

I am 18 years old or older.

I have been diagnosed with PTSD based on the PCL-5 checklist.

Exclusion Criteria

Does not meet criteria for PTSD

Not pregnant or delivered more than 12 weeks after timing of eligibility screening

Current legal actions related to trauma

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive Narrative Exposure Therapy (NET) intervention, which includes psychoeducation, constructing a life events inventory, exposure sessions, and reading of the full written narrative.

12 weeks

Weekly to biweekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Narrative Exposure Therapy (NET)

Trial Overview This study tests Narrative Exposure Therapy (NET) as a treatment for perinatal PTSD against usual care. It's a pilot trial with participants randomly assigned to either receive NET or standard care to compare outcomes.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

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.

Group II: Usual Care Group Active Control 1 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 Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6450467/

The effectiveness of narrative exposure therapy: a review ... Narrative exposure therapy is effective in post-traumatic stress disorder symptom reduction at post-treatment (g = 1.18) and follow-up (g = 1.37).

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1516144/full

Feasibility and preliminary effectiveness of a highly ... Trauma-focused therapies offered in a highly intensive format have been found to lead to higher adherence and faster symptom reduction, but no ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S235201322300100X

The feasibility and preliminary efficacy of narrative ... The study highlights the promising initial effectiveness of narrative exposure therapy in reducing symptoms of post-traumatic stress disorder, depression, and ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cpp.3044

Effectiveness of Narrative Exposure Therapy for Treatment ... Results revealed no significant reduction of PTSD symptoms during NET treatment, nor an increase in quality of life, as compared to baseline.

5. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1585394.pdf

Exposure therapy for PTSD: A meta-analysis Findings support the overall efficacy of exposure therapy and highlight that there are a number of efficacious exposure-based therapies ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03781297

Narrative Exposure Therapy Study for PTSD Among the ... The purpose of this study is to assess the acceptability and feasibility of delivering Narrative Exposure Therapy to homeless individuals with Post-Traumatic ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468749924000395

Narrative exposure therapy for PTSD and structural ... Post-traumatic stress disorder (PTSD) and dissociation symptoms were reduced, and depression scores were not reduced at the point of the three months after NET.

8. psychiatryinvestigation.org psychiatryinvestigation.org/m/journal/view.php?number=1724

Review Article This analysis showed that NET can alleviate depression and anxiety. It may thus be used in clinical settings to alleviate patients' negative feelings and aid ...