Gaze Contingent Feedback in Major Depressive Disorder
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 from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
研究概览
简要总结
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)
详细描述
The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed consent form
- •Men and women between the ages of 18 and
- •Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV
- •MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
- •Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
排除标准
- •Psychotic episode in the past or the present time.
- •Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- •Another psychotherapeutic treatment during the study.
- •Usage of neuroleptic medication.
- •Change in medication status during the study.
- •Substantial usage of drugs or alcohol in the present time.
- •Poor judgment capacity (i.e., children under 18 and special populations).
- •High Risk of Suicide.
结局指标
主要结局
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
时间窗: post treatment (1 week after treatment completion) and 3-month follow up
The SIGMA is a ten-item diagnostic structured interview which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on scale ranging from 0 to 6 with a possible total score of 60, with regard to the passing week.
次要结局
- Change from baseline - BDI-II - Beck Depression Inventory(post treatment (1 week after treatment completion) and 3-month follow up)
研究者
Yair Bar-Haim
Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University
Tel Aviv University