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A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention

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ClinicalTrials.gov Identifier: NCT00482820
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center

Brief Summary:

Studies show that children with high levels of anxiety tend to pay more attention to threatening stimulus in the environment. They tend to attend to these stimuli and have difficulty to disengage from them. These attention biases enhance and maintain the level of anxiety. The aim of this study is to test a method of therapeutically intervention which focuses on shifting these attentional biases, with the use of a computer game which was designed to train the child to focus his/her attention away from the threatening stimuli and to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety disorders who seek treatment. We will first assess threat-related attention bias and anxiety symptoms using structured psychiatric interviews and questionnaires. We will then randomly assign these children to one of four conditions: training to avoid threatening stimuli and attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for positive-neutral stimuli. Upon completion of training we will again assess attention bias and anxiety.

Two sets of predictions will be tested, one set concerns the effects of training on attention, and the other concerns the effects of training on anxiety. In terms of training effects on attention, we hypothesize that children with anxiety disorders can be trained to either avoid threat or attend to positive stimuli. In terms of training effects on anxiety symptoms, we hypothesize that the experimental training sessions will produce greater reduction in symptoms of anxiety than the placebo-control training sessions.


Condition or disease Intervention/treatment Phase
Anxiety Behavioral: attention-bias training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Study Start Date : July 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
attention training away from threat
Behavioral: attention-bias training
one group recive an attention training away from threat. The second group, the controll group, recive a placebo training
Placebo Comparator: 2
placebo attention training
Behavioral: attention-bias training
one group recive an attention training away from threat. The second group, the controll group, recive a placebo training



Primary Outcome Measures :
  1. anxiety questionnaire - that are specified in the protocol. mood scale- as described in the protocol attention bias scores- as described in the protocol [ Time Frame: 2-4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with Clinical diagnosis of Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD).

Exclusion Criteria:

  • Children with the diagnoses of OCD, specific phobia, and PTSD in the absence of comorbid GAD, SP, or SAD.
  • Other exclusion criteria include ongoing major depressive disorder, and use of psychotropic medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482820


Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Bar-Haim Yair, Phd Tel-aviv university; and schnider children's medical center of isreal

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: alan apter, Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00482820     History of Changes
Other Study ID Numbers: 4373
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by alan apter, Rabin Medical Center:
anxiety
attention-biases
children

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders