Effectiveness of Cognitive Processing Therapy in Reducing Post-traumatic Symptoms and Enhancing Birth Outcomes in Pregnant Women With a Previous Pregnancy Loss or Complication
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6
研究概览
简要总结
The purpose of this study is to examine the effects of experiencing a previous pregnancy loss or complication on current physiological and emotional aspects of a current pregnancy.
详细描述
This study will assess the effectiveness of cognitive processing therapy (CPT) or cognitive behavioral therapy (CBT) among women who are experiencing symptoms of post-traumatic stress disorder (PTSD) and/or anxiety relating to a previous pregnancy loss or complication. Lastly, this study includes an option to participate in a procedure whereas startle response will be measured using the eyeblink reflex twice during pregnancy and once in the postpartum period. Startle response is examined using a standard acoustic startle procedure whereby heart rate, skin temperature and eye blinking reflex are measured.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for full PTSD or partial PTSD.
- •Clinician Administered PTSD Scale (CAPS) score of ≥
- •Gestational age at the time of presentation is between 8 and 30 weeks.
- •History of at least one of the following: previous pregnancy loss or losses, voluntary termination due to fetal anomaly, obstetrical complication including childbirth, premature birth (<32 weeks), unexpected neonatal complication, emergency C-section, neonatal death within 28 days of delivery.
- •Fluency in spoken and written English.
排除标准
- •Presence of any lifetime or comorbid DSM-IV Axis I psychotic disorder (including bipolar disorder and MDD (Major Depressive Disorder) with psychotic features and excepting Psychosis NOS (Not Otherwise Specified) related to sensory hallucinations, i.e. reexperiencing symptoms).
- •Presence of any comorbid Axis I or Axis II (as determined using the SCID-II (Structured Clinical Interview for DSM-IV)) disorder, which would require immediate treatment or renders the subject clinically unsuitable for this RTC (randomized clinical trial).
- •History of PTSD due to a NON-Pregnancy related traumatic event.
- •Presence of a known abnormality in the present fetus.
- •Presence of a serious medical or neurological illness.
- •Starting a new psychotropic agent within the previous 3 months.
- •Assessed to require a new psychotropic medication at the screening appointment or an adjustment in current dose of psychotropic medication.
结局指标
主要结局
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6
时间窗: 6 weeks
The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.
次要结局
未报告次要终点