Attentional BiasABMNCT03973580
Using Attention Training to Reduce Adolescents' Anxious Symptoms
A study testing Attentional Bias Modification (ABM) task in people with Attentional Bias and Anxiety, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Attentional Bias, Anxiety
- What is being tested?
- Attentional Bias Modification (ABM) task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English-speaking 11-13-year-old youth without significant medical, psychological, cognitive, or language impairments.
Who cannot join
- Adolescents with clinically significant anxiety disorders or conditions in conflict with MRI scanning (e.g., orthodontics) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
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.
Read the 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.
- Conditions
- Attentional Bias, Anxiety
- Being tested
- Attentional Bias Modification (ABM) task, Control task
- Keywords
- Attentional Bias, Anxiety risk, Adolescence, Eye-tracking, Resting-state functional magnetic resonance imaging
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias Modification (ABM) taskBehavioural
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 taskBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Attentional Bias Modification (ABM) group | Active comparator | Participants in this arm will participate in a six-session ABM task, one session per week. Receives: 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. Receives: Behavioral: Control task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
This outcome will be assessed by a behavioral dot-probe task.
Measured: 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
This outcome will be assessed by an eye-tracking task.
Measured: 6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in resting-state functional connectivity (rsFC)
rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).
Measured: 6 weeks from baseline (after completing the 6th weekly training session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start29 Jul 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attentional BiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Hayden, Western University, Canada
- Investigators
- Elizabeth P Hayden, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973580
- Sponsor's protocol ID
- Western HSREB #113928
- Acronym
- ABM
- Status last verified
- Apr 2023
- First submitted
- 30 May 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for outcome measures will be made available.
Publications
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.
PubMed 28362826Beard 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.
PubMed 23046776Bar-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.
PubMed 17201568Liu 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.
PubMed 29413142
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
- ClinicalTrials.gov ID
- NCT03973580
- Acronym / sponsor ID
- ABM / Western HSREB #113928
- Conditions
- Attentional Bias, Anxiety
- Keywords
- Attentional Bias, Anxiety risk, Adolescence, Eye-tracking, Resting-state functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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).
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Attentional Bias Modification (ABM) group | Active comparator | Behavioral: Attentional Bias Modification (ABM) taskParticipants in this arm will participate in a six-session ABM task, one session per week. |
| Control group | Placebo comparator | Behavioral: Control taskParticipants in this arm will participate in a six-session control task, one session per week. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- English-speaking 11-13-year-old youth without significant medical, psychological, cognitive, or language impairments.
Key exclusion criteria (1 listed)
- Adolescents with clinically significant anxiety disorders or conditions in conflict with MRI scanning (e.g., orthodontics) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attentional Bias Modification (ABM) taskParticipants 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. | Behavioural | Attentional Bias Modification (ABM) group |
| Control taskThe 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). | Behavioural | Control group |
Primary outcome
Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up
Time frame: 3 weeks from baseline (after completing the 3rd weekly training session)
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
Time frame: 6 weeks from baseline (after completing the 6th weekly training session)
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
Time frame: 3 weeks from baseline (after completing the 3rd weekly training session)
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
Time frame: 6 weeks from baseline (after completing the 6th weekly training session)
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 secondary outcomes
Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up
Time frame: 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
Time frame: 6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in resting-state functional connectivity (rsFC)
Time frame: 6 weeks from baseline (after completing the 6th weekly training session)
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 28362826Sanchez 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 publication: PubMed 23046776Beard 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 publication: PubMed 17201568Bar-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 publication: PubMed 29413142Liu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth P Hayden, Ph.D principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional Bias Modification (ABM) task in people with Attentional Bias and Anxiety, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up (time frame: 3 weeks from baseline (after completing the 3rd weekly training session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973580, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.