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Completed

NCT Number: NCT02303691

Attention Bias Modification for Transdiagnostic Anxiety

This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. A computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. This work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Department of Psychiatry

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will:
  • be between the ages of 18 and 55 years,
  • score >45 on the Spielberger State-Trait Anxiety Inventory-trait form.
  • score >=75th percentile on the World Health Organization Disability Assessment Schedule 2.0

Exclusion criteria

  • Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
  • Failure to meet standard Magnetic Resonance Imaging (MRI) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, Intrauterine Devices, metal braces, or other metal objects in their body, especially in the eye. If the subject has any metal or implants in the body they must be deemed safe by the MRI Research Center's safety screening procedure prior to enrollment. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on females.
  • currently suicidal or at risk for harm to self or others,
  • visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed)
  • <6th grade reading level as per the Wide Range Achievement Test
  • presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
  • positive urine drug test

Treatment and study plan

Attention Bias Modification

Behavioral

Excessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations.

Neutral Training

Behavioral

A control version of computerized attention training.

Primary outcomes

  1. CAPS--Hypervigilance item

    Time frame: 1 month

Secondary outcomes

  1. Mood and Anxiety Symptoms Questionnaire

    Time frame: 1 month

  2. Mini International Neuropsychiatric Interview (MINI)

    Time frame: 1 month

  3. Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)

    Time frame: immediate

    Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking

  4. Penn State Worry Questionnaire

    Time frame: 1 month

  5. Liebowitz Social Anxiety Scale

    Time frame: 1 month

  6. World Health Organization Disability Assessment Scale (WHODAS)

    Time frame: 1 month

  7. Speilberger State-Trait Anxiety Inventory

    Time frame: 1 month

  8. Beck Anxiety Inventory

    Time frame: 1 month

Other outcomes

  1. Functional Magnetic Resonance Imaging

    Time frame: 1 month

    (collected post-treatment in subsample of active arm only)

  2. Pupillometry

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Dec 1, 2014
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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