Using Attention Training to Reduce Adolescents' Anxious Symptoms (ABM)

Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)

During adolescence, youth undergo rapid developmental change and in some cases experience increases in worries and fearfulness, although the mechanisms that underlie this change are unclear. Previous studies indicate that heightened Attentional Bias (AB) toward threat-related cues may increase fearfulness, and it may be possible to change AB using a computerized, Attention Bias Modification task (ABM). This study will recruit healthy youth with elevated anxious symptoms to index attentional tendencies toward threat-related stimuli using cutting-edge techniques, and to test the effect of a computerized attention training task in altering attention to threatening cues. The investigators will also examine the role of ABM in changing youth's attention-related resting-state functional connectivity (rsFC), a neural marker of at-rest cognition.

Study Overview

• Status: Terminated
• Conditions: Anxiety; Attentional Bias
• Intervention / Treatment: Behavioral: Attentional Bias Modification (ABM) task; Behavioral: Control task

Detailed Description

Adolescence is a critical period for increases in anxious symptoms, potentially due to etiologically significant Attention Biases (AB) favoring threatening cues. However, the specific facets of AB that drive this vulnerability as well as their neurocognitive correlates are unclear, due in large part to the poor psychometric properties of the traditional assessment of AB in this field. By using both a standard behavioral task and a novel eye-tracking task, this study aims to unpack the nuanced facets of AB related to anxiety risks. Additionally, well-controlled Attentional Bias Modification (ABM) tasks designed to train attention away from threatening cues can be used to experimentally manipulate the causal mechanisms of interest, and to test whether ABM reduces symptoms and alters patterns of resting-state functional connectivity (rsFC, the intrinsic brain activity that occurs outside specific tasks) that characterize anxiety risks.

This study will recruit 60 11-13-year-old healthy adolescents with heightened anxious symptoms but without clinically significant anxiety disorders. They will be randomized to a six-session ABM training or a placebo task. Both before and after the training, the investigators will assess their anxious symptoms, AB, and rsFC. By examining the risk processes prior to the onset of clinically significant anxiety disorders, our work will make important new contributions to our understanding of how AB eventuates in anxiety and will have direct implications for early identification of youth at highest risk for anxiety disorders, and the targets that should be focused on in preventative efforts.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth P Hayden, Ph.D; Phone Number: 519-661-3686; Email: ehayden@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5B7
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English-speaking 11-13-year-old youth without significant medical, psychological, cognitive, or language impairments.

Exclusion Criteria:

• Adolescents with clinically significant anxiety disorders or conditions in conflict with MRI scanning (e.g., orthodontics) will be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attentional Bias Modification (ABM) group; Participants in this arm will participate in a six-session ABM task, one session per week.	Behavioral: Attentional Bias Modification (ABM) task; Participants will be presented with a fixation cross (500ms) followed by a pair of identity-matched, angry-neutral faces (1000ms). The pair presentation is replaced by a single arrow-probe (1000ms) in the position of the neural face. Inter-trial intervals (ITI) are 500ms. Participants indicate arrow direction (left or right) by pressing one of two buttons as quickly as possible. By responding to the probe that always replaces the neutral face, participants learn to attend to the non-threat cues and away from threat cues. There are 120 trials of angry-neutral faces in total, and 40 other catch trials with neutral-neutral faces.
Placebo Comparator: Control group; Participants in this arm will participate in a six-session control task, one session per week.	Behavioral: Control task; The control task is identical with the ABM task, except that in the 120 angry-neutral trials, the arrow-probe replaces the angry face and the neutral face with equal probabilities (60 trials each).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up	Parent-reported anxious symptoms will be assessed by the Child Behavior Checklist questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.	3 weeks from baseline (after completing the 3rd weekly training session)
Change from baseline in parent-reported anxious symptoms at 6 weeks follow-up	Parent-reported anxious symptoms will be assessed by the Child Behavior Checklist questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.	6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in youth self-reported anxious symptoms at 3 weeks follow-up	Youth self-reported anxious symptoms will be assessed by the Youth Self Report questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.	3 weeks from baseline (after completing the 3rd weekly training session)
Change from baseline in youth self-reported anxious symptoms at 6 weeks follow-up	Youth self-reported anxious symptoms will be assessed by the Youth Self Report questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.	6 weeks from baseline (after completing the 6th weekly training session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up	This outcome will be assessed by a behavioral dot-probe task.	6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in eye-movement-indexed Attentional Bias (AB) at 6 weeks follow-up	This outcome will be assessed by an eye-tracking task.	6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in resting-state functional connectivity (rsFC)	rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).	6 weeks from baseline (after completing the 6th weekly training session)

Collaborators and Investigators

• Sponsor: Western University, Canada

Publications and helpful links

General Publications

• Beard C, Sawyer AT, Hofmann SG. Efficacy of attention bias modification using threat and appetitive stimuli: a meta-analytic review. Behav Ther. 2012 Dec;43(4):724-40. doi: 10.1016/j.beth.2012.01.002. Epub 2012 Jan 18.
• Sanchez A, Romero N, De Raedt R. Depression-related difficulties disengaging from negative faces are associated with sustained attention to negative feedback during social evaluation and predict stress recovery. PLoS One. 2017 Mar 31;12(3):e0175040. doi: 10.1371/journal.pone.0175040. eCollection 2017.
• Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IJzendoorn MH. Threat-related attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull. 2007 Jan;133(1):1-24. doi: 10.1037/0033-2909.133.1.1.
• Liu P, Taber-Thomas BC, Fu X, Perez-Edgar KE. Biobehavioral Markers of Attention Bias Modification in Temperamental Risk for Anxiety: A Randomized Control Trial. J Am Acad Child Adolesc Psychiatry. 2018 Feb;57(2):103-110. doi: 10.1016/j.jaac.2017.11.016. Epub 2017 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Adolescence; Eye-tracking; Attentional Bias; Resting-state functional magnetic resonance imaging; Anxiety risk
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Western HSREB #113928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the PI. Requests with the sole purpose of research will be approved. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No