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临床试验/NCT02945735
NCT02945735已完成不适用

Gaze Contingent Feedback in Major Depressive Disorder

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月6日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yair Bar-Haim

Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Tel Aviv University

研究点 (1)

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