NCT03092609

Brief Summary

Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is an increased attentional bias to threat, which has been identified as a causal contributor in the development of anxiety. Given this causal relationship, attention bias modification was introduced as a treatment option where anxiety is reduced by training individuals to direct their attention away from threat and thereby decreasing anxiety. Over a decade of research using this approach, called attention bias modification (ABM), suggests that overall the approach is effective in reducing anxiety. Although ABM appears to be a very promising treatment option for anxiety, there are several factors limiting the effectiveness of ABM. These include the recognition of individual-level needs and a known underlying mechanism of action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to visual threat is associated with a network of brain regions including the amygdala, anterior cingulate cortex, and visual cortex. In human participants, experience-dependent neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume following training. Recently, voxel-based morphometry measures of gray matter volume have been linked to dendritic spine density-a known cellular mechanism for learning-related neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure learning-related neuroplasticity following attention bias modification. In this proposal participants' level of attentional bias, anxiety, and gray matter volume will be measured before and after completing six weeks of attention bias modification training (N = 50) or attention control training (N= 50). The proposal aims to (1) establish that pre-treatment bias predicts variability in gray matter volume in the extended amygdala and anterior cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior cingulate cortex gray matter volume following ABM underlies reductions in attentional bias and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and NIMH's focus on identifying and validating new targets for treatment development that underlie disease mechanisms, the current proposal plans to involve students at a rural primarily undergraduate university in a research project aimed at establishing neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism for ABM training outcome, which could be used to objectively track training-related outcomes in anxiety treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2020

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

March 14, 2017

Last Update Submit

January 11, 2022

Conditions

Keywords

Attentional Bias to Threat

Outcome Measures

Primary Outcomes (1)

  • Attentional Bias

    Reaction time difference to congruent and incongruent trials in the dot-probe task, which measure heightened attentional bias to threat.

    Baseline and after 6 weeks of the intervention

Secondary Outcomes (1)

  • State and Trait Anxiety

    Baseline and after 6 weeks of the intervention

Other Outcomes (2)

  • MRI measures of gray matter volume

    Baseline and after 6 weeks of the intervention

  • MRI measures of structural and functional connectivity

    Baseline and after 6 weeks of the intervention

Study Arms (2)

Attention Bias Modification

EXPERIMENTAL
Behavioral: Attention Bias Modification

Attention Control

ACTIVE COMPARATOR
Behavioral: Attention Control

Interventions

Attention bias modification (ABM) sessions will consist of a modified dot-probe task that only contains incongruent trials (i.e., target-dot - neutral stimulus 100% pairing).

Attention Bias Modification

Attention control (AC) sessions, will consist of a standard dot-probe task (i.e., target-dot - neutral/threat stimulus 50% pairing). Thus, for AC participants, bias should remain the same, while ABM participants should show a reduced bias to threat.

Attention Control

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Handedness (right handed)
  • Normal Vision
  • High Anxiety
  • Preexisting Attentional Bias

You may not qualify if:

  • No MRI contraindications
  • No History of Head Injury
  • No Neurological History
  • Psychological History
  • Limited Recreational Drug Use, No Abuse
  • Limited Prescription Drug Use, No Abuse
  • No Claustrophobia
  • Not Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Michigan University

Marquette, Michigan, 49855, United States

Location

Related Publications (2)

  • Carlson JM, Fang L, Koster EHW, Andrzejewski JA, Gilbertson H, Elwell KA, Zuidema TR. Neuroplastic changes in anterior cingulate cortex gray matter volume and functional connectivity following attention bias modification in high trait anxious individuals. Biol Psychol. 2022 Jul;172:108353. doi: 10.1016/j.biopsycho.2022.108353. Epub 2022 May 13.

  • Carlson JM, Fang L. Attentional bias to threat and gray matter volume morphology in high anxious individuals. Cogn Affect Behav Neurosci. 2022 Jun;22(3):600-609. doi: 10.3758/s13415-021-00968-9. Epub 2021 Nov 9.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Joshua M Carlson, PhD

    Northern Michigan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 28, 2017

Study Start

December 15, 2017

Primary Completion

March 14, 2020

Study Completion

March 14, 2020

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Data will be uploaded to the NIMH Data Archive

Locations