Using Attention Training to Reduce Adolescents' Anxious Symptoms

NCT ID: NCT03973580

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Attentional Bias Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sixty adolescents will be randomly assigned to an active ABM task (n=30) or a control task (n=30) in parallel for the duration of the study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The randomized assignment procedure will be conducted solely by the PI. All other research staff and participants will be blind to the assigned condition throughout the course of the study. The PI will use a random number generator in Excel to assign a number 1-10 for each participant. The number will be given to the study coordinator, who notes the number in the participant's file. Participants will be assessed by the coordinator or other research staff. The research staff goes to each participant's home to conduct the ABM training protocol, where the number noted in this participant's file will be entered at the start of the training task to assign the participant to either the ABM task or the control task. The PI will not run the tasks. In communicating with participants, the terms baseline, outcome, and training will not be used.

Study Groups

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Attentional Bias Modification (ABM) group

Participants in this arm will participate in a six-session ABM task, one session per week.

Group Type ACTIVE_COMPARATOR

Attentional Bias Modification (ABM) task

Intervention Type BEHAVIORAL

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.

Control group

Participants in this arm will participate in a six-session control task, one session per week.

Group Type PLACEBO_COMPARATOR

Control task

Intervention Type BEHAVIORAL

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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Hayden

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth P Hayden, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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Western University

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 28362826 (View on PubMed)

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.

Reference Type RESULT
PMID: 23046776 (View on PubMed)

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.

Reference Type RESULT
PMID: 17201568 (View on PubMed)

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.

Reference Type RESULT
PMID: 29413142 (View on PubMed)

Other Identifiers

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Western HSREB #113928

Identifier Type: -

Identifier Source: org_study_id

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