Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): attention bias modification for anxiety
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: RCT of Attention Bias Modification
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention bias modification, anxiety, event-related potentials