Attention Bias Modification for Anxiety: A Randomized Control Trial With Biomarkers

NCT02200003 | Completed Phase 2 DMC

• 1 other identifier: 1 SC MH 109349-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

attention bias modification, anxiety, event-related potentials

Outcome Measures

Primary Outcomes (3)

• Change in anxiety severity - immediate post intervention

  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

  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

  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 Outcomes (3)

• Change in neural responses to threat

  Change in neural responses to threat will be assessed five weeks after the baseline assessment

• Change in behavioral stress reactivity

  Change in behavioral stress reactivity will be assessed five weeks after the baseline assessment

• Change in physiological measures of stress reactivity

  Change in physiological stress reactivity will be assessed five weeks after the baseline assessment

Study Arms (2)

Attention Bias Modification

EXPERIMENTAL

640 Trials (20 minutes) four times over four weeks

Behavioral: attention bias modification for anxiety

Sham Attention bias modification

SHAM COMPARATOR

640 Trials (20 minutes) four times over four weeks

Behavioral: attention bias modification for anxiety

Interventions

attention bias modification for anxiety BEHAVIORAL

Attention Bias Modification; Sham Attention bias modification

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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:

• 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.

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Hunter College of the City University of New York

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tracy Dennis, Ph.D.

  Hunter College of The City University of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: RCT of Attention Bias Modification

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 25, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (1)