ABMT: Attention Bias Modification Treatment for Anxious Youth

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT01979263

Collaborator

(none)

Enrollment

Locations

Arms

39.6

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia Specific Phobia Obsessive-Compulsive Disorder	Other: Attention Bias Modification Computer Task Other: Placebo Computer Task	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 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 :

Oct 1, 2013

Actual Primary Completion Date :

Jan 17, 2017

Actual Study Completion Date :

Jan 17, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Variation in genes associated with treatment response [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Payne Whitney Manhattan Child Division	New York	New York	United States	10065
2	New York Presbyterian Hospital--Westchester Division	White Plains	New York	United States	10605