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Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers

Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02200003
Acronym
ABMT
Enrollment
100
Registered
2014-07-25
Start date
2015-02-28
Completion date
2018-07-31
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

attention bias modification, anxiety, event-related potentials

Brief summary

Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective, and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT is effective, limiting clinical translation. The proposed research involves an RCT using a highly sensitive measure of neurocognitive functioning, scalp-recorded event-related potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety. Researchers will recruit 90 anxious participants to engage in the study and pursue the following three specific aims: Aim 1 will examine relations between neural and behavioral responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat, threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and reductions in threat bias and anxiety. Researchers will test whether post-training neural changes, specified in Aim 2, are associated with reductions in behavioral threat bias and anxiety severity. Researchers will also explore whether ERP measures of greater attention capture and/or reduced control of attention to threat at baseline predict treatment response, helping identify which patients will benefit most from ABMT. Through the innovative combination of a highly sensitive neurocognitive measure and an RCT design, this study aims to delineate core neurocognitive responses to threat as mechanisms in the remediation of anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of development of more biologically-informed, accessible, and targeted interventions for anxiety.

Detailed description

Anxiety disorders are the most common psychiatric diagnosis, affecting as many as 29% of people during their lifetime. In addition to the devastating personal cost of anxiety, the yearly economic cost to society has been estimated to be around $46.6 billion in the U.S. Empirically-based treatments for anxiety have improved in recent years, but barriers to access, side effects, and high remission rates (\ 50%) suggest the need for complementary treatments. Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective, and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or exaggerated attention feared or threatening stimuli. Two decades of research show that reducing threat bias via computerized ABMT also reduces anxiety severity at levels comparable to gold-standard treatments. Despite its promise, no randomized clinical trials (RCTs) have evaluated specific mechanisms underlying ABMT's effects on anxiety, nor identified predictors of treatment response. Therefore, it remains unclear how and for whom ABMT is effective, limiting clinical translation. This study is a randomized clinical trial using a highly sensitive measure of neurocognitive functioning to delineate key mechanisms of an emerging treatment for anxiety. Specifically, the study will use scalp-recorded event-related potentials (ERPs) to elucidate neurocognitive processes implicated in attention bias modification treatment (ABMT) and to predict treatment response. Researchers will recruit 90 anxious patients to engage in the study and pursue the following three specific aims: Aim 1 will examine relations between neural and behavioral responses to threat prior to ABMT. Researchers will test whether greater behavioral threat bias is associated with ERP responses indicating greater attention capture by threat (larger P1 and P2 ERPs), and reduced top-down control of attention to threat (smaller N2, N2pc, P3 ERPs). Aim 2 will examine the effects of ABMT on ERPs to threat, threat bias, and anxiety. Analyses will focus on whether ABMT relative to placebo training will result in greater reductions in automatic attention capture and/or controlled attention to threat measured via ERPs. Aim 3 will examine relations between ERP responses to threat and reductions in threat bias and anxiety. Researchers will test whether post-training neural changes, specified in Aim 2, will be associated with reductions in behavioral threat bias and anxiety severity. These predicted relations,together with those tested in Aim 2a, support the utility of these ERPs as neural markers for the specific cognitive processes underlying ABMT efficacy. Researchers will also explore whether ERP measures of greater attention capture and/or reduced control of attention to threat at baseline predict treatment response, helping identify which patients will benefit most from ABMT. Through the innovative combination of a highly sensitive neurocognitive measure and an RCT design, this proposal aims to delineate core neurocognitive responses to threat as mechanisms in the remediation of anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of development of more biologically-informed, accessible, and targeted interventions for anxiety.

Interventions

BEHAVIORALattention bias modification for anxiety

Sponsors

Hunter College of City University of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

RCT of Attention Bias Modification

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* We will recruit ninety adults with moderate to severe symptoms of anxiety between the ages of 21 and 40, with an equal balance of males and females.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety severity - immediate post interventionChange in anxiety severity will be assessed five weeks after the baseline assessmentDiagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
Change in threat biasChange in threat bias will be assessed five weeks after the baseline assessmentRT-based measures of facilitated attention to threat (e.g., dot probe)
Change in anxiety severity - four-month follow-upChange in anxiety severity will be assessed four months after the post-intervention assessment - a total of five months, one week from the baseline assessmentDiagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating

Secondary

MeasureTime frameDescription
Change in neural responses to threatChange in neural responses to threat will be assessed five weeks after the baseline assessmentScalp-recorded event-related potential measures (P1, P2, N2, P3) in response to threat stimuli
Change in behavioral stress reactivityChange in behavioral stress reactivity will be assessed five weeks after the baseline assessmentObserved and subjective feelings of stress and anxiety during the Trier Social Stress Test
Change in physiological measures of stress reactivityChange in physiological stress reactivity will be assessed five weeks after the baseline assessmentHeart rate and skin conductance during the Trier Social Stress Test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026