- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200003
Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers (ABMT)
July 30, 2018 updated by: Tracy Dennis, Hunter College of City University of New York
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Hunter College of the City University of New York
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attention Bias Modification
640 Trials (20 minutes) four times over four weeks
|
|
Sham Comparator: Sham Attention bias modification
640 Trials (20 minutes) four times over four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety severity - immediate post intervention
Time Frame: Change in anxiety severity will be assessed five weeks after the baseline assessment
|
Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
|
Change in anxiety severity will be assessed five weeks after the baseline assessment
|
Change in threat bias
Time Frame: Change in threat bias will be assessed five weeks after the baseline assessment
|
RT-based measures of facilitated attention to threat (e.g., dot probe)
|
Change in threat bias will be assessed five weeks after the baseline assessment
|
Change in anxiety severity - four-month follow-up
Time Frame: Change in anxiety severity will be assessed four months after the post-intervention assessment - a total of five months, one week from the baseline assessment
|
Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
|
Change in anxiety severity will be assessed four months after the post-intervention assessment - a total of five months, one week from the baseline assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in neural responses to threat
Time Frame: Change in neural responses to threat will be assessed five weeks after the baseline assessment
|
Scalp-recorded event-related potential measures (P1, P2, N2, P3) in response to threat stimuli
|
Change in neural responses to threat will be assessed five weeks after the baseline assessment
|
Change in behavioral stress reactivity
Time Frame: Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment
|
Observed and subjective feelings of stress and anxiety during the Trier Social Stress Test
|
Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment
|
Change in physiological measures of stress reactivity
Time Frame: Change in physiological stress reactivity will be assessed five weeks after the baseline assessment
|
Heart rate and skin conductance during the Trier Social Stress Test
|
Change in physiological stress reactivity will be assessed five weeks after the baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tracy Dennis, Ph.D., Hunter College of the City University of New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
July 21, 2014
First Submitted That Met QC Criteria
July 23, 2014
First Posted (Estimate)
July 25, 2014
Study Record Updates
Last Update Posted (Actual)
August 1, 2018
Last Update Submitted That Met QC Criteria
July 30, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 SC MH 109349-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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