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Attention Bias Modification Treatment for Anxious Youth (ABMT)

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ClinicalTrials.gov Identifier: NCT01979263
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth.

Condition or disease Intervention/treatment
Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia Specific Phobia Obsessive-Compulsive Disorder Other: Attention Bias Modification Computer Task Other: Placebo Computer Task

Detailed Description:

The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.

This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.

If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Treatment for Anxious Youth
Study Start Date : October 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Attention Bias Modification
Attention Bias Modification computer task
Other: Attention Bias Modification Computer Task
Computer task aimed at actively modifying attention bias
Placebo Comparator: Placebo Computer Task
Placebo computer task
Other: Placebo Computer Task
Computer task that does not actively modify attention bias



Primary Outcome Measures :
  1. Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version [ Time Frame: after a 6-week intervention and 4-week no-treatment follow-up ]

Secondary Outcome Measures :
  1. Variation in genes associated with treatment response [ Time Frame: week 1 ]
    We will study allelic variation in a gene that has been associated with treatment response to anxiety interventions, the serotonin-transporter-linked promoter region (5-HTTLPR)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
  • Age 7 to 17

Exclusion Criteria:

  • Posttraumatic stress disorder or primary diagnosis of major depressive disorder
  • Seizure disorder
  • Current treatment with psychotropic medication
  • Multiple chronic learning disabilities and/or conduct problems

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): NCT01979263


Locations
United States, New York
Payne Whitney Manhattan Child Division
New York, New York, United States, 10065
New York Presbyterian Hospital--Westchester Division
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Megan H Feltenberger, PhD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01979263     History of Changes
Other Study ID Numbers: 1207012686R001-IRB
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobic Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Personality Disorders
Neurodevelopmental Disorders