Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Nonepileptic seizure frequency
研究概览
简要总结
An outpatient randomized controlled clinical trial conducted at the Northeast Regional Epilepsy Group's PNES Program, involving mental health clinicians certified in PE and trained in administering PsychoEd.
详细描述
A randomized parallel group trial was utilized to compare two therapeutic interventions for PNES, PE or PsychoEd, both delivered remotely via teletherapy. Each psychotherapeutic modality provided 12, 90-minute sessions. Seizure frequency was the primary outcome measure. Secondary outcome measures were depression (Beck Depression Inventory) and post-traumatic stress symptomatology (Post-Traumatic Disorder Diagnostic Scale and PTSD Checklist). Data was collected prospectively, including baseline measures before initiating treatment, upon treatment completion, and at follow-up intervals of 3, 6, and 12-months post-treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults (18 years and older) Confirmed diagnosis of PNES through video-EEG monitoring Confirmed diagnosis of current PTSD At least one psychogenic non-epileptic seizure in the month prior to beginning treatment.
排除标准
- •Concurrent mixed epilepsy and PNES or video EEG findings that cannot clearly distinguish epilepsy and PNES Active suicidality Active psychotic symptoms Active substance or alcohol use or dependence that could interfere with participation in therapy Application for disability
研究组 & 干预措施
Prolonged exposure
干预措施: imaginal and in vivo exposure (Behavioral)
Psychoeducational Intervention for PNES
This psychoeducational treatment was based on a similar intervention reported in 2004
干预措施: psychoeducation for psychogenic nonepileptic seizures (Behavioral)
结局指标
主要结局
Nonepileptic seizure frequency
时间窗: From enrollment until session 12 and at 3, 6 and 12month follow up
frequency of nonepileptic seizures (PNES) per month
次要结局
- Beck Depression Inventory (BDI)(From enrollment to session 12 and at 3, 6 and 12 months follow up)
- Posttraumatic Stress Disorder Checklist (PCL) for DSM 5(From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up)
- Posttraumatic Diagnostic Scale(From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up)
- Clinician Administered PTSD Scale for DSM 5 (CAPS)(From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up)
研究者
Dr. Lorna Myers
Director, PNES Program
Northeast Regional Epilepsy Group