Anxiety Clinical Trial
— ABMOfficial title:
Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
Verified date | April 2023 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 13 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Western University | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) |
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