跳至主要内容
临床试验/NCT01730625
NCT01730625已完成不适用

Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial

Tel Aviv University0 个研究点目标入组 119 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
主要终点
Change in frequency of anxiety symptoms (based on ADIS)

研究概览

简要总结

The development of easily disseminated and efficacious treatment of psychiatric disorder is an important goal for translational neuroscience research. To that end, Attention Bias Modification Treatment (ABMT), a novel intervention targeting threat-related attention biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the treatment of choice for anxiety disorders. Studying this question in youth is particularly important given that the onset of most anxiety disorders is during childhood, and early interventions may reduce long-term affliction. The current study is the first randomized control trial designed to examine the augmenting effects of ABMT on CBT among clinically anxious youth.

The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic tool. During training, the target location is systematically manipulated to increase the proportion of targets appearing at the location opposite the patient's bias. For example, in a training protocol intended to reduce threat bias, targets would appear more frequently at locations of neutral than threat stimuli.

Although CBT is an effective treatment for anxiety disorders, combining it with other treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two interventions targeting different aspects of anxiety and therefore could potentially complement one another. While CBT modifies explicit and voluntary attention through verbal intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT, the integration of the two treatments can have few significant benefits: First, it will combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce the number of patients who respond poorly to CBT or do not respond at all. Second, computer-based training of attention may be more acceptable than traditional in-person therapy formats for some children and adolescents and can raise the cooperation in therapy. Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered consistently

The current study was designed to examine the ABMT augmentation effects on CBT for children with anxiety disorders. This study is the first randomized control trial in clinically anxious youth. Participants were randomly assigned to one of three conditions: 1. Training condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT alone). We hypothesize that participants in the training condition will show the greatest improvement in anxiety symptoms.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children ranging in age from 6 - 18 year
  • At least one clinical diagnoses of either separation anxiety disorder (SAD), social phobia (SP), specific phobia, or generalized anxiety disorder (GAD) (American Psychiatric Association [APA], 1994)

排除标准

  • Lifetime history of psychosis
  • Child's inability to comply to CBT
  • Diagnosis of post traumatic stress disorder (PTSD), diagnosis of obsessive compulsive disorder (OCD), or selective mutism

结局指标

主要结局

Change in frequency of anxiety symptoms (based on ADIS)

时间窗: Change from baseline to up to 3 weeks after last treatment session

Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.

Change in severity of anxiety symptoms (based on ADIS)

时间窗: Change from baseline to up to 3 weeks after last treatment session

ADIS interview (see above)

次要结局

  • SCARED parent/child(pre and post treatment)

研究者

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

Yair Bar-Haim

Prof. Yair Bar-Haim, Ph.D.

Tel Aviv University

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