Attention Bias Modification for Transdiagnostic Anxiety

Neural Dimensions of 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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Anxiety
• Intervention / Treatment: Behavioral: Attention Bias Modification; Behavioral: Neutral Training

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants will:

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

Exclusion Criteria:

1. Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
2. 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.
3. currently suicidal or at risk for harm to self or others,
4. visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed)
5. <6th grade reading level as per the Wide Range Achievement Test
6. presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
7. positive urine drug test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized Attention Bias Modification	Behavioral: Attention Bias Modification; 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.
Sham Comparator: Computerized Neutral Training	Behavioral: Neutral Training; A control version of computerized attention training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CAPS--Hypervigilance item	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood and Anxiety Symptoms Questionnaire		1 month
Mini International Neuropsychiatric Interview (MINI)		1 month
Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)	Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking	immediate
Penn State Worry Questionnaire		1 month
Liebowitz Social Anxiety Scale		1 month
World Health Organization Disability Assessment Scale (WHODAS)		1 month
Speilberger State-Trait Anxiety Inventory		1 month
Beck Anxiety Inventory		1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Magnetic Resonance Imaging	(collected post-treatment in subsample of active arm only)	1 month
Pupillometry		1 month

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Price RB, Cummings L, Gilchrist D, Graur S, Banihashemi L, Kuo SS, Siegle GJ. Towards personalized, brain-based behavioral intervention for transdiagnostic anxiety: Transient neural responses to negative images predict outcomes following a targeted computer-based intervention. J Consult Clin Psychol. 2018 Dec;86(12):1031-1045. doi: 10.1037/ccp0000309.
• Price RB, Brown V, Siegle GJ. Computational Modeling Applied to the Dot-Probe Task Yields Improved Reliability and Mechanistic Insights. Biol Psychiatry. 2019 Apr 1;85(7):606-612. doi: 10.1016/j.biopsych.2018.09.022. Epub 2018 Oct 5.

Helpful Links

• NIH reporter page for NIMH K23 award

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: anxiety; computer; attention bias modification
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 5K23MH100259 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No