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Attention Bias Modification Treatment for Anxious Youth (ABMT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01979263
First received: September 30, 2013
Last updated: September 9, 2016
Last verified: September 2016
  Purpose
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 Intervention
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
Specific Phobia
Obsessive-Compulsive Disorder
Other: Attention Bias Modification Computer Task
Other: Placebo Computer Task

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Treatment for Anxious Youth

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variation in genes associated with treatment response [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 44
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01979263     History of Changes
Other Study ID Numbers: 1207012686R001-IRB 
Study First Received: September 30, 2013
Last Updated: September 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on September 30, 2016