Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
研究概览
简要总结
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:
Does PE+ decrease PTSD symptoms?
All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.
Participants will:
- Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
- Receive financial incentives for attending each PE+ session.
- Attend assessment visits every 4 weeks for the 12 weeks of the trial.
- Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Gestational age ≤ 25 weeks
- •Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- •Participants receiving psychotropic medications must be maintained on a stable dose for >14 days prior to enrollment.
排除标准
- •Under 18 years old
- •Gestational age > 25 weeks
- •No current diagnosis of PTSD
- •Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
- •Enrolled in another ongoing evidence-based treatment for PTSD.
研究组 & 干预措施
Prolonged exposure therapy + incentives for therapy session attendance
干预措施: Prolonged exposure therapy + incentives for therapy session attendance (Behavioral)
结局指标
主要结局
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
时间窗: From baseline to the 12-week assessment
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
时间窗: From baseline to the 12-week assessment
Change in treatment acceptability as measured by the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item scale, each with a range of 1-7 and some of which are reverse-scored. The total TAAS score is calculated by summing the score for the 10 TAAS items and the overall TAAS score ranges from 10-70, with higher scores representing better outcomes (greater treatment acceptability).
次要结局
- Change in posttraumatic stress disorder symptom severity - self-reported(From baseline to the 12-week assessment)
- Mean change in subjective units of distress(Within 1-hour)
- Change in self-reported posttraumatic stress disorder symptom severity between PE sessions(In the 1 week)
- Prolonged exposure therapy discontinuation(From baseline to the 12-week assessment)
- Neonatal birth weight(Delivery)
- Gestational age at delivery(Delivery)
- Maternal delivery complications(Delivery)
- Change in posttraumatic stress disorder symptom severity - self-reported(From baseline to the 12-week assessment)
- Mean change in subjective units of distress(Within 1-hour)
- Mean percent change in heart rate(Within 1-hour)
- Change in self-reported posttraumatic stress disorder symptom severity between PE sessions(In the 1 week)
- Prolonged exposure therapy discontinuation(From baseline to the 12-week assessment)
- Neonatal birth weight(Delivery)
- Gestational age at delivery(Delivery)
- Maternal delivery complications(Delivery)
研究者
Kelly Peck
Professor
University of Vermont