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临床试验/NCT01819311
NCT01819311已完成不适用

Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Florida International University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年4月1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
入组人数
64
试验地点
1
主要终点
Clinician Rating on the Pediatric Anxiety Rating Scale

研究概览

简要总结

This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.

详细描述

This application proposes a pilot test of Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder a full year after completion of CBT. There is currently not a single empirical study in the youth anxiety treatment literature that has systematically examined a treatment augment for youth who fail to respond to a full course of CBT. Empirical efforts to address this issue are important because youths who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders, experience frustration and demoralization by perceived "failure," and likely pose a financial burden on the health care system.

ABMT is a novel translational treatment for anxiety based on experimental and neuroscience research findings on attention processes. Research demonstrates that ABMT leads to reductions in anxiety and its disorders. Based on recent theory and research demonstrating an attention bias toward threat predicts CBT nonresponse among anxious youth, researchers have postulated that ABMT may hold promise as an augment to CBT because of its specific focus on attention bias that targets both frontal-cortical and subcortical circuitry.

This study will recruit an estimated 70 children and adolescents who have completed a 12-14 week CBT trial for anxiety disorders and at the one year follow-up continue to meet criteria for a primary diagnosis of an anxiety disorders. These 70 children and adolescents (ages 8-16 years) will be randomly assigned to complete eight biweekly sessions of either ABMT or a placebo control (PC) task. Clinician ratings on youth anxiety severity will be collected and evaluated as the primary outcome. Youth self ratings on anxiety symptoms and parent ratings on youth anxiety symptoms will be collected and evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an eight week follow up. The following specific aims will be addressed.

Aim 1: Test whether ABMT leads to significantly lower levels of anxiety at posttreatment as compared to a Placebo Control Task.

Aim 2: Examine whether ABMT leads to significantly lower levels of anxiety as compared to a Placebo Control Task at a follow up evaluation eight weeks posttreatment. This would suggest the maintenance of ABMT effects after eight weeks of no treatment.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •8-16 years old
  • •completed a 12-14 week cognitive behavioral therapy for anxiety
  • •a primary DSM-IV diagnosis of generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder
  • •if other psychiatric disorders are present, they must be treated with medication and stable

排除标准

  • •meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation
  • •a high likelihood of harming self or others
  • •not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation
  • •previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services;
  • •involved currently in another psychosocial/behavioral treatment
  • •a serious vision problem that is not corrected with prescription lenses
  • •a physical disability that interferes with the ability to click a mouse button rapidly and repeatedly

研究组 & 干预措施

Attention Bias Modification

Experimental

Attention Bias Modification is a computer-based attention training program

干预措施: Attention Bias Modification (Behavioral)

Placebo Attention Task

Placebo Comparator

The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.

干预措施: Placebo Attention Task (Behavioral)

结局指标

主要结局

Clinician Rating on the Pediatric Anxiety Rating Scale

时间窗: 8-week follow-up

The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

Clinician Rating on the Pediatric Anxiety Rating Scale

时间窗: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

次要结局

  • Screen for Child Anxiety Related Emotional Disorders - Parent Version(8-week follow-up)
  • Screen for Child Anxiety Related Emotional Disorders - Child Version(8-week follow-up)
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version(post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification))
  • Screen for Child Anxiety Related Emotional Disorders - Child Version(post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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