The New Empowerment After eXposure to Trauma (NEXT) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Feasibility Tracking
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Study statistician
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Narrative Exposure Therapy (NET) (Behavioral)
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.
结局指标
主要结局
Feasibility Tracking
时间窗: 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
时间窗: 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)
时间窗: 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).
次要结局
- PTSD Checklist for DSM-5 (PCL-5)(*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)(*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)(Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline))
- Perinatal Quality of Life(Baseline, post-intervention time period (12 weeks post-baseline), and follow-up (24 weeks post-baseline))
研究者
Michelle L. Miller
Assistant Professor
Indiana University