Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- CGI
研究概览
简要总结
Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics. There is no known empirically validated treatment approach to functional symptoms. Cognitive Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision. The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as compared to treatment as usual (TAU) improves patient outcomes.
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
- •Adult neurology outpatient with functional symptoms not largely explained by neurologic disease.
排除标准
- •Unable to use the Guided Self-Help intervention, such as due to significant cognitive impairment or unable to comprehend English.
- •Requires specialist psychiatric care.
- •Has headache as the only symptom.
研究组 & 干预措施
TAU+GSH
Treatment As Usual plus Guided Self Help.
干预措施: Guided Self-Help (Behavioral)
TAU
Treatment AS Usual.
干预措施: Treatment As Usual (Behavioral)
TAU+GSH
Treatment As Usual plus Guided Self Help.
干预措施: Treatment As Usual (Behavioral)
结局指标
主要结局
CGI
时间窗: 3 months
Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.
次要结局
未报告次要终点