Attention Bias Modification for Transdiagnostic Anxiety

NCT02303691 | Completed

• 1 other identifier: 5K23MH100259
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Anxiety Disorders

Keywords

anxiety; attention bias modification; computer

Outcome Measures

Primary Outcomes (1)

• CAPS--Hypervigilance item

  1 month

Secondary Outcomes (8)

• 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)

  immediate

• Penn State Worry Questionnaire

  1 month

• Liebowitz Social Anxiety Scale

  1 month

Other Outcomes (2)

• Functional Magnetic Resonance Imaging

  1 month

• Pupillometry

  1 month

Study Arms (2)

Computerized Attention Bias Modification

EXPERIMENTAL

Behavioral: Attention Bias Modification

Computerized Neutral Training

SHAM COMPARATOR

Behavioral: Neutral Training

Interventions

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.

Computerized Attention Bias Modification

Neutral Training BEHAVIORAL

A control version of computerized attention training.

Computerized Neutral Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Department of Psychiatry

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 30507228 DERIVED

• 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.

  PMID: 30449531 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: April 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (1)