Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers
Completed · Phase 2 · Has a placebo group
Conditions studied: Anxiety
In brief
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.
Key facts
- Study ID
- NCT02200003
- Run by
- Hunter College of City University of New York
- People needed
- 100
- Starts
- 2015-02-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-08-01
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Exclusion criteria include current or past episodes of disorders that include psychotic features (e.g., mania, schizophrenia, etc.,), suicidal intent, substance dependence, changes in pharmacological treatments during the 12 weeks prior to study entry, any concurrent psychotherapy, and serious medical illness.
- Other current and/or past Axis I diagnoses will not be excluded, but will be tracked.
- Given high rates of co-morbidity with anxiety, depressive symptoms will also be measured to assess impact on findings.
- To ensure understanding of the protocol, other exclusion criteria include inability to read, inability to complete assessments (i.e., severely impaired), and lack of English language comprehension.
Where it is running
- Hunter College of the City University of New York — New York, New York, United States
Full record on ClinicalTrials.gov
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