Clinical trial NCT03973580: Using Attention Training to Reduce Adolescents' Anxious Symptoms
Official title: Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attentional Bias
Anxiety
Keywords: Attentional Bias
Anxiety risk
Adolescence
Eye-tracking
Resting-state functional magnetic resonance imaging
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up
timeFrame: 3 weeks from baseline (after completing the 3rd weekly training session)
measure: Change from baseline in parent-reported anxious symptoms at 6 weeks follow-up
timeFrame: 6 weeks from baseline (after completing the 6th weekly training session)
measure: Change from baseline in youth self-reported anxious symptoms at 3 weeks follow-up
timeFrame: 3 weeks from baseline (after completing the 3rd weekly training session)
measure: Change from baseline in youth self-reported anxious symptoms at 6 weeks follow-up
timeFrame: 6 weeks from baseline (after completing the 6th weekly training session)
Secondary outcomes:
measure: Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up
timeFrame: 6 weeks from baseline (after completing the 6th weekly training session)
measure: Change from baseline in eye-movement-indexed Attentional Bias (AB) at 6 weeks follow-up
timeFrame: 6 weeks from baseline (after completing the 6th weekly training session)
measure: Change from baseline in resting-state functional connectivity (rsFC)
timeFrame: 6 weeks from baseline (after completing the 6th weekly training session)
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Elizabeth P Hayden, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.