Using Attention Training to Reduce Adolescents' Anxious Symptoms

NCT03973580 | Terminated

• 1 other identifier: Western HSREB #113928
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Attentional Bias; Anxiety

Keywords

Attentional Bias; Anxiety risk; Adolescence; Eye-tracking; Resting-state functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up

  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

  6 weeks from baseline (after completing the 6th weekly training session)

• Change from baseline in resting-state functional connectivity (rsFC)

  6 weeks from baseline (after completing the 6th weekly training session)

Study Arms (2)

Attentional Bias Modification (ABM) group

ACTIVE COMPARATOR

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

Behavioral: Attentional Bias Modification (ABM) task

Control group

PLACEBO COMPARATOR

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

Behavioral: Control task

Interventions

Attentional Bias Modification (ABM) task 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.

Attentional Bias Modification (ABM) group

Control task 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).

Control group

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6A 5B7, Canada

Location

Related Publications (4)

• 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.

  PMID: 28362826 BACKGROUND

• 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.

  PMID: 23046776 RESULT

• 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.

  PMID: 17201568 RESULT

• 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.

  PMID: 29413142 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elizabeth P Hayden, Ph.D

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: July 29, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• 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.

Locations

CA (1)