Mindfulness-based Psychotherapy and Social Support Intervention for Drug-resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention
研究概览
简要总结
Psychological problems are prevalent among patients with drug-resistant epilepsy. The bi-directional interaction between psychological well-being and seizure have been recognized in recent years. Reduction of psychological stress has the potential to improve seizure manifestation.
The present study uses an assessor-blinded prospective randomized controlled trial to evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social support on improving psychological well-being, seizure control and cognitive performance among adult patients with drug-resistant epilepsy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of epilepsy
- •over 18 years of age
- •resistant to pharmacological treatment according to the ILAE guideline
- •no previous history of neurosurgery
- •adequate level of reading and understanding ability to fill in questionnaires
- •capable to communicate with the investigator with considerable expressive capacity
- •patients who agree to cooperate with the study procedures required by the protocol
- •patients who understand the nature of the study, agree to participate and sign the informed consent form
排除标准
- •with primary diagnosis of substance use disorder, mood disorder, bipolar affective disorder, psychosis, or organic mental disorder
- •with diagnosis of learning disability or mental retardation
研究组 & 干预措施
Social support group
Social support group is an attention-placebo with the same contact hours (four bi-weekly two-and-a-half-hour) as the experimental group, but without active treatment input. The aim of the social support group is to provide a supportive group atmosphere for patients with drug-resistant epilepsy.
干预措施: Social support group (Behavioral)
Mindfulness-based therapy
Mindfulness-based therapy is a four biweekly two-and-a-half-hour psychotherapy tailored for patients with drug-resistant epilepsy. The aims of this therapy are to introduce and practice mindfulness-based stress reduction techniques in coping with drug-resistant epilepsy.
干预措施: Mindfulness-based therapy (Behavioral)
结局指标
主要结局
Change in quality of life (Quality of Life in Epilepsy Inventory-31-P Total Score) from baseline to post-intervention
时间窗: Baseline, 4-week post-intervention
次要结局
未报告次要终点
研究者
Venus Tang
Dr
Chinese University of Hong Kong