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临床试验/NCT03971903
NCT03971903已完成不适用

Department of Psychology, Hunan Normal University

Hunan Normal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Changes of depressive symptoms

研究概览

简要总结

In this study, the investigators test whether a 4-week 12-session attention bias modification treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the investigators also test whether a 2-week 4-session ABMT booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up

详细描述

Attention Bias Modification Training was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. The placebo training procedure is a classic dot-probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month and 12-month follow-ups after training.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses

排除标准

  • a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).

研究组 & 干预措施

Attention bias modification treatment

Experimental

12-session of ABMT

干预措施: Attention bias modification (Behavioral)

Placebo controls

Placebo Comparator

12-session of placebo(i.e.,sham) training

干预措施: Attention bias modification (Behavioral)

结局指标

主要结局

Changes of depressive symptoms

时间窗: pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )

Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

Changes of attention bias score

时间窗: pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )

Attention bias score changes tested by a typical dot-probe task

Changes of severity of depression

时间窗: pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )

The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D)

次要结局

  • Changes of self-reported trait anxiety(pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training ))
  • Changes of self-reported rumination(pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training ))
  • Changes of self-reported depressive symptoms(pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training ))

研究者

发起方
Hunan Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenhui Yang

Department of Psychology

Hunan Normal University

研究点 (1)

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