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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT02200003
Study groupRoleWhat they receive
Attention Bias ModificationExperimental640 Trials (20 minutes) four times over four weeks
Receives: Behavioral: attention bias modification for anxiety
Sham Attention bias modificationSham comparator640 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted25 Jul 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2018
  4. Study completionJul 2018

Resources

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)
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

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.

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