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

Primary Purpose

Attentional Bias, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Attentional Bias Modification (ABM) task
Control task
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attentional Bias focused on measuring Attentional Bias, Anxiety risk, Adolescence, Eye-tracking, Resting-state functional magnetic resonance imaging

Eligibility Criteria

11 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Attentional Bias Modification (ABM) group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Change from baseline in resting-state functional connectivity (rsFC)
rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).

Full Information

First Posted
May 30, 2019
Last Updated
April 25, 2023
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03973580
Brief Title
Using Attention Training to Reduce Adolescents' Anxious Symptoms
Acronym
ABM
Official Title
Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of the COVID-19 pandemic (Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention).
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attentional Bias, Anxiety
Keywords
Attentional Bias, Anxiety risk, Adolescence, Eye-tracking, Resting-state functional magnetic resonance imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attentional Bias Modification (ABM) group
Arm Type
Active Comparator
Arm Description
Participants in this arm will participate in a six-session ABM task, one session per week.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will participate in a six-session control task, one session per week.
Intervention Type
Behavioral
Intervention Name(s)
Attentional Bias Modification (ABM) task
Intervention Description
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
Intervention Name(s)
Control task
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up
Description
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.
Time Frame
3 weeks from baseline (after completing the 3rd weekly training session)
Title
Change from baseline in parent-reported anxious symptoms at 6 weeks follow-up
Description
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.
Time Frame
6 weeks from baseline (after completing the 6th weekly training session)
Title
Change from baseline in youth self-reported anxious symptoms at 3 weeks follow-up
Description
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.
Time Frame
3 weeks from baseline (after completing the 3rd weekly training session)
Title
Change from baseline in youth self-reported anxious symptoms at 6 weeks follow-up
Description
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.
Time Frame
6 weeks from baseline (after completing the 6th weekly training session)
Secondary Outcome Measure Information:
Title
Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up
Description
This outcome will be assessed by a behavioral dot-probe task.
Time Frame
6 weeks from baseline (after completing the 6th weekly training session)
Title
Change from baseline in eye-movement-indexed Attentional Bias (AB) at 6 weeks follow-up
Description
This outcome will be assessed by an eye-tracking task.
Time Frame
6 weeks from baseline (after completing the 6th weekly training session)
Title
Change from baseline in resting-state functional connectivity (rsFC)
Description
rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).
Time Frame
6 weeks from baseline (after completing the 6th weekly training session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth P Hayden, Ph.D
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
28362826
Citation
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.
Results Reference
background
PubMed Identifier
23046776
Citation
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.
Results Reference
result
PubMed Identifier
17201568
Citation
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.
Results Reference
result
PubMed Identifier
29413142
Citation
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.
Results Reference
result

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Using Attention Training to Reduce Adolescents' Anxious Symptoms

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