Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry Guided Breathing Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Percentage of participants initiating assigned treatment
研究概览
简要总结
The purpose of this study is to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivered a live infant within 5 days
- •Severe maternal morbidity or infant admitted to NICU
- •PCL-5 ≥28
- •English-speaking
- •Able to consent and participate
排除标准
- •Active psychosis or mania
- •Current suicidal crisis
- •Current suicidal intent or plan
- •Cognitive impairment preventing participation
研究组 & 干预措施
Postpartum Standard of Care
Participants will follow their current standard of care.
Capnometry-Guided Breathing Intervention (CGRI)
Participants will complete one 45-minute in-hospital training session using the device, which includes a tablet and breathing sensor. They will then practice guided breathing at home twice daily for about 17 minutes each time for 4 weeks, with weekly phone check-ins from study staff.
干预措施: Capnometry-Guided Breathing Intervention (CGRI) (Device)
Written Exposure Therapy (WET)
Participants will complete 5 writing sessions. One 50-minute session will be held in the hospital before discharge, followed by four 50-minute sessions by secure video once a week. Sessions are delivered by a trained study therapist under licensed clinician supervision.
干预措施: Written Exposure Therapy (WET) (Behavioral)
结局指标
主要结局
Percentage of participants initiating assigned treatment
时间窗: Baseline (up to 2 weeks)
Proportion of participants who begin their assigned intervention (≥1 session for WET; completion of initial training for CGRI)
Percentage of participants completing Written Exposure Therapy (WET)
时间窗: Baseline to Week 6
Percentage adherence to Written Exposure Therapy (WET)
时间窗: Baseline to Week 6
Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)
时间窗: Baseline to Week 6
Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)
时间窗: Baseline to Week 6
Participant Satisfaction Scale Score using Client Satisfaction Questionnaire (CSQ-8)
时间窗: Week 5
Participant satisfaction measured using the CSQ-8 questionaire, an 8-item scale. (Scale score 8 - 32. Higher scores represent greater satisfaction with treatment.)
Treatment credibility using the Opinion About Treatment (OAT) form
时间窗: Week 5
Participant perceptions of treatment credibility will be measured using the OAT form. (Scale score 3 - 27. Higher scores represent greater perceived credibility of the intervention.)
次要结局
- Change from baseline in PTSD Checklist for DSM-5 (PCL-5) Scale Score(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12)
- Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) Scale Score(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 12)
- Change from baseline in Whole Person Health Index (WPHI) Scale Score(Baseline, Week 3, Week 6, Week 12)
- Change from baseline in Generalized Anxiety Disorder Questionaire (GAD-7)(Baseline, Week 3, Week 6, Week 12)
- Change from baseline in Maternal-infant bonding (MIBS) Scale Score(Baseline, Week 3, Week 6, Week 12)
- Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score(Baseline, Week 3, Week 6, Week 12)
- Change from baseline in Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF)(Baseline, Week 3, Week 6, Week 12)
- Percentage of participants completing hair sample collection at Baseline and Week 6(Baseline, Week 6)
- Change in hair cortisol concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair cortisone concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair testosterone concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair progesterone concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair corticosterone concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair dehydroepiandrosterone (DHEA) concentration between Baseline and Week 6(Baseline, Week 6)
- Change in hair androstenedione concentration between Baseline and Week 6(Baseline, Week 6)
研究者
Pervez Sultan
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)
Stanford University