Attention Bias Modification Treatment for Anxious Youth

Obsessive-Compulsive Disorder Clinical Trial

— ABMT  

Official title:

Attention Bias Modification Treatment for Anxious Youth

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01979263
• Other study ID #: 1207012686R001-IRB
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 17, 2017

Study information

• Verified date: July 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder
• Phobia, Social
• Phobic Disorders
• Separation Anxiety Disorder
• Social Phobia
• Specific Phobia

Intervention

Other:
• Attention Bias Modification Computer Task
Computer task aimed at actively modifying attention bias
• Placebo Computer Task
Computer task that does not actively modify attention bias

Locations

Country	Name	City	State
United States	Payne Whitney Manhattan Child Division	New York	New York
United States	New York Presbyterian Hospital--Westchester Division	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version		after a 6-week intervention and 4-week no-treatment follow-up
Secondary	Variation in genes associated with treatment response	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)	week 1