Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Beck Depression Inventory score
研究概览
简要总结
The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.
详细描述
patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.
The second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •Diagnosed with TLE according to the criteria of the International League Against Epilepsy
- •Literates had sign an informed consent
- •Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression
排除标准
- •Patients with high risk of suicide who required hospitalization
- •Patients who abused or are dependent on drugs
- •Those with a history of head trauma six months prior to the interview
- •Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
- •Patients who have previously received CBT
- •Patients who have started, an antidepressant drug the last 8 weeks
研究组 & 干预措施
Cognitive behavioral Therapy
CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy.
12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.
干预措施: Cognitive behavioral therapy (Other)
Selective serotonin euptake inhibitor
Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.
干预措施: SSRI (Drug)
结局指标
主要结局
Change in Beck Depression Inventory score
时间窗: baseline, 6 weeks and 12 weeks
次要结局
- Quality of Life in Epilepsy Scale(baseline, 6 weeks and 12 weeks)
- Hospital anxiety and depression scale (HADS)(baseline, 4weeks and 12 weeks)
研究者
Edgar Daniel Crail Melendez
Md
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez