Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Feasibility via retention rate (sessions completed/dropout rate)
研究概览
简要总结
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented.
Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures.
Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention.
Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment.
Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews.
With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).
详细描述
Investigators will conduct a feasibility and acceptability study of Narrative Exposure Therapy (NET) to treat up to 30 pregnant trauma survivors with clinically-significant symptoms of PTSD.
Up to 100 participants will be recruited with the aim of enrolling 30 participants in NET. Pregnant patients will be recruited from Rush OB/GYN resident training clinics. The racial/ethnic composition of patients served at these clinics (>70% ethno-racial minorities) will ensure that participants of color will be highly represented. Methods of recruitment include NET brochures that will be placed in the clinic's waiting rooms, OB/GYN physicians and nurse referring patients with a known history of trauma, and a 2-item screening measure -- the PTSD Checklist, Civilian Version (PCL-2) -- at the patient's initial OB appointment to facilitate recruitment.
Following initial referral, the study team will conduct a brief phone screen to ensure basic eligibility criteria are met, describe the study purpose, and schedule eligible participants for an initial study session (week 0). During the initial visit participants will sign informed consent and complete self-report measures (week 1 of the study) - after which they will then be enrolled in the intervention (weeks 1-6 of the study). Participants will complete post-treatment self-report measures and treatment evaluation measures at 1 week and 1-month following their last NET session (week 7 and week 10, respectively), and again at 1-month postpartum. The participant will also be invited to complete a qualitative feedback interview upon completion of the intervention (or early withdrawal from intervention).
Participants will be compensated for completion of all assessments and study components.
Due to the Coronavirus/COVID-19 pandemic, all study activities will be conducted via telephone or telehealth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility via retention rate (sessions completed/dropout rate)
时间窗: Week 1 (NET Session 1) to Week 6 (NET Session 6)
Investigators will calculate the mean number of sessions attended and the dropout rate, recording reason for drop out, such as participants' desire to withdraw from the NET treatment vs. medical complications of pregnancy or early delivery.
Acceptability of the NET intervention via participant satisfaction
时间窗: 1 Week Post-treatment (Post-treatment evaluation)
Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).
Feasibility via recruitment rate
时间窗: Screening to enrollment (Week 1)
Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.
Acceptability of the NET intervention via participant expectancy
时间窗: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)
Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.
Acceptability of the NET intervention via qualitative feedback
时间窗: Upon study completion (up to 10 months) or upon early withdrawal from intervention
Primary outcome will include qualitative feedback regarding aspects of the NET intervention and its acceptability during pregnancy and in preparation for the transition to parenthood via a study-developed qualitative interview.
Change in Symptoms of PTSD
时间窗: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will use the Posttraumatic Check List for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Feasibility via retention rate (completion of follow-up questionnaires)
时间窗: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)
Investigators will calculate the mean number of follow-up questionnaires completed.
Acceptability of the NET intervention via perceived benefit
时间窗: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.
次要结局
- Change in Symptoms of Perinatal Depression(Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation))
研究者
Natalie Stevens
Research Director
Rush University Medical Center