Cognitive Behavioural Therapy in Dissociative Seizures: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- seizure frequency
研究概览
简要总结
The purpose of this study is to determine whether adults with disoociative (psychogenic non-epileptic) seizures receiving cognitive behavioural therapy (CBT) show a greater reduction in seizures and health service use and greater improvement in employment status and overall psychosocial functioning than patients who receive standard care.
详细描述
Preliminary results from a pilot study demonstrated that cognitive behavioural therapy (CBT) is associated with a significant benefit for patients with dissociative seizures. The current study aims to extend these findings by conducting a randomised controlled trial comparing CBT with standard outpatient medical care. Standard outpatient care has been chosen as the comparison treatment as it most closely resembles what is currently offered to this group of patients by the National Health Service. The primary outcome measure will be seizure frequency. Secondary outcome measures will be work and social adjustment and health service use.
Our hypothesis is that CBT will be superior to standard outpatient care for patients with dissociative seizures as determined by the above measures.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of dissociative seizures
- •diagnosis confirmed by video EEG telemetry where practicable
- •aged 16 - 70
排除标准
- •co existent diagnosis (past or present) of epilepsy
- •seizure frequency of less than 2 seizures per month
- •current alcohol or drug abuse
- •benzodiazepine use exceeding the equivalent of 10mg diazepam per day.
结局指标
主要结局
seizure frequency
时间窗: previous month
次要结局
- Employment Status(Pre-treatment, end of treatment and six-months follow-up)
- Health Service Use(Pre-treatment, end of treatment and six-months follow-up)
- seizure freedom(3 months)
- Work & Social Adjustment scale (Marks, 1986)(Pre-treatment, end of treatment and six-months follow-up)
- Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)(Pre-treatment, end of treatment and six-months follow-up)