AnxietyPhase 2ABMTNCT02200003
Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers
A Phase 2 study testing attention bias modification for anxiety in people with Anxiety, run by Hunter College of City University of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anxiety
- What is being tested?
- attention bias modification for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2018
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter College of the City University of New York
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- attention bias modification for anxiety
- Keywords
- attention bias modification, anxiety, event-related potentials
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attention bias modification for anxietyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification | Experimental | 640 Trials (20 minutes) four times over four weeks Receives: Behavioral: attention bias modification for anxiety |
| Sham Attention bias modification | Sham comparator | 640 Trials (20 minutes) four times over four weeks Receives: Behavioral: attention bias modification for anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety severity - immediate post intervention
Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
Measured: Change in anxiety severity will be assessed five weeks after the baseline assessment
Change in threat bias
RT-based measures of facilitated attention to threat (e.g., dot probe)
Measured: Change in threat bias will be assessed five weeks after the baseline assessment
Change in anxiety severity - four-month follow-up
Diagnostic interview using anxiety disorder modules only (MINI) and anxiety/impairment severity rating
Measured: 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 outcomes (3)
Change in neural responses to threat
Scalp-recorded event-related potential measures (P1, P2, N2, P3) in response to threat stimuli
Measured: Change in neural responses to threat will be assessed five weeks after the baseline assessment
Change in behavioral stress reactivity
Observed and subjective feelings of stress and anxiety during the Trier Social Stress Test
Measured: Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment
Change in physiological measures of stress reactivity
Heart rate and skin conductance during the Trier Social Stress Test
Measured: Change in physiological stress reactivity will be assessed five weeks after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- RCT of Attention Bias Modification
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Dennis, Hunter College of The City University of New York
- Investigators
- Tracy Dennis, Ph.D., Principal investigator, Hunter College of The City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200003
- Sponsor's protocol ID
- 1 SC MH 109349-01
- Acronym
- ABMT
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2014
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers
- ClinicalTrials.gov ID
- NCT02200003
- Acronym / sponsor ID
- ABMT / 1 SC MH 109349-01
- Conditions
- Anxiety
- Keywords
- attention bias modification, anxiety, event-related potentials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT of Attention Bias Modification
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification | Experimental | Behavioral: attention bias modification for anxiety640 Trials (20 minutes) four times over four weeks |
| Sham Attention bias modification | Sham comparator | Behavioral: attention bias modification for anxiety640 Trials (20 minutes) four times over four weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| attention bias modification for anxiety | Behavioural | Attention Bias Modification, Sham Attention bias modification |
Primary outcome
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 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 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
3 secondary outcomes
Change in neural responses to threat
Time frame: 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
Change in physiological measures of stress reactivity
Time frame: Change in physiological stress reactivity will be assessed five weeks after the baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
Tracy Dennis, Ph.D. principal investigator
Hunter College of The City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing attention bias modification for anxiety in people with Anxiety, run by Hunter College of City University of New York at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 1 Aug 2018. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in anxiety severity - immediate post intervention (time frame: Change in anxiety severity will be assessed five weeks after the baseline assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2018.