The New Empowerment After eXposure to Trauma (NEXT) Study
Purpose
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.
Conditions
- PTSD - Post Traumatic Stress Disorder
- PTSD (Childbirth-Related)
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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 12 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 - unstable dose of psychiatric medications (must be stable for 6 weeks) - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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).
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- Study statistician
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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|
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. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
