Attention Bias Modification Treatment for Anxious Youth (ABMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01979263
First received: September 30, 2013
Last updated: November 22, 2013
Last verified: November 2013
  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

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 Primary Completion Date: October 2015 (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

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
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
  • Concurrent psychotherapy
  • Baseline attention bias toward threat of less than 8 msec (as measured at evaluation)
  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

Contacts
Contact: Megan E Hughes, PhD 914-997-8688 meh9033@med.cornell.edu
Contact: Alex E Keller, BA 212-746-5930 alk2021@med.cornell.edu

Locations
United States, New York
Payne Whitney Manhattan Child Division Recruiting
New York, New York, United States, 10065
Contact: Shannon Bennett, PhD    212-821-0789    smb9017@med.cornell.edu   
Contact: Alex E Keller, BA    212-746-5930    alk2021@med.cornell.edu   
Principal Investigator: Shannon Bennett, PhD         
New York Presbyterian Hospital--Westchester Division Recruiting
White Plains, New York, United States, 10605
Contact: Megan E Hughes, PhD    914-997-8688    meh9033@med.cornell.edu   
Principal Investigator: Megan E Hughes, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Megan E Hughes, PhD Weill Medical College of Cornell University
  More Information

No publications provided

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: November 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Obsessive-Compulsive Disorder
Phobic Disorders
Compulsive Personality Disorder
Mental Disorders Diagnosed in Childhood
Personality Disorders

ClinicalTrials.gov processed this record on August 28, 2014