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临床试验/NCT02460536
NCT02460536已完成不适用

Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)

研究概览

简要总结

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious 10-18 year-olds. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. Attentional threat bias, Attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of ABMT efficacy.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of GAD, SOP, or SAD.
  • Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
  • Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.

排除标准

  • To be excluded youth must:
  • meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
  • show high likelihood of hurting themselves or others.
  • have not been living with a primary caregiver who is legally able to give consent for the child's participation.
  • be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
  • be involved currently in another psycho-social treatment.
  • have a serious vision problem that is not corrected with prescription lenses.
  • have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

研究组 & 干预措施

Attention Bias Modification treatment (ABMT)

Experimental

Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.

干预措施: Attention Bias Modification treatment (ABMT) (Behavioral)

Exposure only +ABMT

Active Comparator

Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.

干预措施: Exposure only +ABMT (Behavioral)

Attention training only +ABMT

Active Comparator

Attention training via repeated trials of a dot-probe task using non-emotional stimuli.

干预措施: Attention training only +ABMT (Behavioral)

Placebo group

Placebo Comparator

Identical discrimination task including a single non-emotional stimulus in each trial.

干预措施: Placebo group (Behavioral)

结局指标

主要结局

Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)

时间窗: 4 weeks, 8 weeks, and 18 weeks (follow-up)

The PARS assesses global anxiety severity across different anxiety disorders in youth.

次要结局

  • Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P)(4 weeks, 8 weeks, and 18 weeks (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, Head School of Psychological Sciences

Tel Aviv University

研究点 (1)

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