The New Empowerment After eXposure to Trauma (NEXT) Study

Indiana University

Status: Enrolling

Conditions: PTSD - Post Traumatic Stress Disorder; PTSD (Childbirth-Related)

Treatments: Behavioral: Narrative Exposure Therapy (NET)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07175025

K23HD115845 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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 16 weeks) at the time of the eligibility screen Exclusion criteria
• current severe suicide risk
• current psychotic or manic symptoms
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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.

Treatment:

Behavioral: Narrative Exposure Therapy (NET)

Usual Care Group

No Intervention group

Description:

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.