CClinicalTrials.gg
TerminatedNCT01979263ABMTUpdated Jul 30, 2019

Attention Bias Modification Treatment for Anxious Youth

An interventional study of Attention Bias Modification Computer Task and Placebo Computer Task in Generalized Anxiety Disorder, Separation Anxiety Disorder and Social Phobia, sponsored by Weill Medical College of Cornell University. Terminated at 2 sites in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Why this study was terminated
Insufficient recruitment/data collection
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
  • Social Phobia
  • Specific Phobia
  • Obsessive-Compulsive Disorder
03

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    Attention Bias Modification

    Attention Bias Modification computer task

    Other: Attention Bias Modification Computer Task

  • Placebo comparator
    Placebo Computer Task

    Placebo computer task

    Other: Placebo Computer Task

Interventions

  • OtherAttention Bias Modification Computer Task

    Computer task aimed at actively modifying attention bias

  • OtherPlacebo Computer Task

    Computer task that does not actively modify attention bias

05

What researchers measure

Primary outcomes

  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 outcomes

  1. 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)

    Time frame: week 1

06

Study locations

2 sites
  • Payne Whitney Manhattan Child Division
    New York, New York 10065, United States
  • New York Presbyterian Hospital--Westchester Division
    White Plains, New York 10605, United States
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT01979263
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Nov 8, 2013
Start date
Oct 2013
Primary completion
Jan 17, 2017
Completion
Jan 17, 2017
Last update
Jul 30, 2019

Study contacts

Megan H Feltenberger, PhD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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